Axitinib (AG-013736) For the Treatment of Metastatic Renal Cell Cancer
Sponsor
Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT00920816
Collaborator
(none)
492
125
2
140.1
3.9
0
Study Details
Study Description
Brief Summary
The study is designed to demonstrate that axitinib (AG-013736) is superior to sorafenib in delaying tumor progression in patients with metastatic renal cell cancer.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
492 participants
Allocation:
Randomized
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
AG-013736 (AXITINIB) FOR THE TREATMENT OF METASTATIC RENAL CELL CANCER
Actual Study Start Date
:
Aug 25, 2009
Actual Primary Completion Date
:
Jul 27, 2012
Actual Study Completion Date
:
Apr 29, 2021
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: A
|
Drug: Axitinib (AG-013736)
axitinib will be given at a starting dose of 5 mg BID with continuous dosing
|
| Active Comparator: B
|
Drug: Sorafenib
sorafenib will be given at a dose of 400 mg BID continuous dosing
|
Outcome Measures
Primary Outcome Measures
- Progression Free Survival (PFS): First-Line Participants [Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 107)]
Time in months from randomization to first documentation of objective tumor progression or death due to any cause. PFS calculated as (first event date minus date of randomization plus 1)/30.4. Tumor progression determined from oncologic assessment data (where it meets criteria for progressive disease [PD]), or from adverse event (AE) data (where outcome was "Death"). Progression using Response Evaluation Criteria in Solid Tumors (RECIST) is >= 20 percent (%) increase in sum of longest diameter of target lesions; measurable increase in non-target lesion; appearance of new lesions.
- Progression Free Survival (PFS): Second-Line Participants [Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 103)]
Time in months from randomization to first documentation of objective tumor progression or death due to any cause. PFS calculated as (first event date minus date of randomization plus 1)/30.4. Tumor progression determined from oncologic assessment data (where it meets criteria for progressive disease [PD]), or from adverse event (AE) data (where outcome was "Death"). Progression using Response Evaluation Criteria in Solid Tumors (RECIST) is >= 20 percent (%) increase in sum of longest diameter of target lesions; measurable increase in non-target lesion; appearance of new lesions.
Secondary Outcome Measures
- Percentage of Participants With Objective Response (OR): First-Line Participants [Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 107)]
Percentage of participants with OR based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST. Confirmed response were those that persisted on repeat imaging study at least 4 weeks after initial documentation of response. CR was defined as disappearance of all lesions (target and/or non target). PR were those with at least 30 percent decrease in sum of the longest dimensions of target lesions taking as a reference the baseline sum longest dimensions, with non target lesions not increased or absent.
- Percentage of Participants With Objective Response (OR): Second-Line Participants [Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 103)]
Percentage of participants with OR based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST. Confirmed response were those that persisted on repeat imaging study at least 4 weeks after initial documentation of response. CR was defined as disappearance of all lesions (target and/or non target). PR were those with at least 30 percent decrease in sum of the longest dimensions of target lesions taking as a reference the baseline sum longest dimensions, with non target lesions not increased or absent.
- Duration of Response (DR): First-Line Participants [Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 107)]
Time in months from the first documentation of objective tumor response that is subsequently confirmed to objective tumor progression or death due to any cause. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to any cause minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 30.4. DR was calculated for the subgroup of participants with a confirmed objective tumor response.
- Duration of Response (DR): Second-Line Participants [Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 103)]
Time in months from the first documentation of objective tumor response that is subsequently confirmed to objective tumor progression or death due to any cause. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to any cause minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 30.4. DR was calculated for the subgroup of participants with a confirmed objective tumor response.
- Overall Survival (OS): First-Line Participants [Baseline until death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 107)]
Time in months from date of randomization to date of death due to any cause. OS was calculated as (the death date minus the date of randomization plus 1) divided by 30.4. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).
- Overall Survival (OS): Second-Line Participants [Baseline until death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 103)]
Time in months from date of randomization to date of death due to any cause. OS was calculated as (the death date minus the date of randomization plus 1) divided by 30.4. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).
Other Outcome Measures
- Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): First-Line Participants [Baseline (Pre-dose on Cycle [C]1 Day [D]1), D1 of each cycle until C23, end of treatment (up to Week 107), follow-up (28 days after last dose)]
FKSI-15 questionnaires (lack of energy, side effects, pain, weight loss, bone pain, fatigue, enjoying life, short of breath, worsened condition, appetite, coughing, bothered by fevers, ability to work, hematuria, sleep) was used to assess quality of life (QoL) for those diagnosed with renal cell cancer. Questions answered on 5-point Likert scale: 0 to 4 (0= not at all, 1= little bit, 2= somewhat, 3= quite a bit, 4= very much). Total FKSI score 0 to 60; higher scores=better health states (Individual questions may be reversed coded, as appropriate).
- Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): Second-Line Participants [Baseline (Pre-dose on Cycle [C]1 Day [D]1), D1 of each cycle until C21, end of treatment (up to Week 103), follow-up (28 days after last dose)]
FKSI-15 questionnaires (lack of energy, side effects, pain, weight loss, bone pain, fatigue, enjoying life, short of breath, worsened condition, appetite, coughing, bothered by fevers, ability to work, hematuria, sleep) was used to assess quality of life (QoL) for those diagnosed with renal cell cancer. Questions answered on 5-point Likert scale: 0 to 4 (0= not at all, 1= little bit, 2= somewhat, 3= quite a bit, 4= very much). Total FKSI score 0 to 60; higher scores=better health states (Individual questions may be reversed coded, as appropriate).
- Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): First-Line Participants [Baseline (Pre-dose on Cycle [C]1 Day [D]1), D1 of each cycle until C23, end of treatment (up to Week 107), follow-up (28 days after last dose)]
FKSI-DRS: subset of FKSI which is FACT-Kidney Symptom Index questionnaire used to assess QoL for participants diagnosed with renal cell cancer. FKSI contains 15 questions and FKSI-DRS 9 questions (lack of energy, pain, losing weight, bone pain, fatigue, short of breath, coughing, bothered by fevers, hematuria) each ranging from 0 (not at all) to 4 (very much). FKSI-DRS total score 0 to 36; higher scores associated with better health states (Individual questions may be reversed coded, as appropriate).
- Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): Second-Line Participants [Baseline (Pre-dose on Cycle [C]1 Day [D]1), D1 of each cycle until C21, end of treatment (up to Week 103), follow-up (28 days after last dose)]
FKSI-DRS: subset of FKSI which is FACT-Kidney Symptom Index questionnaire used to assess QoL for participants diagnosed with renal cell cancer. FKSI contains 15 questions and FKSI-DRS 9 questions (lack of energy, pain, losing weight, bone pain, fatigue, short of breath, coughing, bothered by fevers, hematuria) each ranging from 0 (not at all) to 4 (very much). FKSI-DRS total score 0 to 36; higher scores associated with better health states (Individual questions may be reversed coded, as appropriate).
- Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: First-Line Participants [Baseline (Pre-dose on Cycle [C]1 Day [D]1), D1 of each cycle until C23, end of treatment (up to Week 107), follow-up (28 days after last dose)]
EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
- Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: Second-Line Participants [Baseline (Pre-dose on Cycle [C]1 Day [D]1), D1 of each cycle until C21, end of treatment (up to Week 103), follow-up (28 days after last dose)]
EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
- Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): First-Line Participants [Baseline (Pre-dose on Cycle [C]1 Day [D]1), D1 of each cycle until C23, end of treatment (up to Week 107), follow-up (28 days after last dose)]
EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0: worst imaginable health state to 100: best imaginable health state; higher scores indicate a better health state.
- Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): Second-Line Participants [Baseline (Pre-dose on Cycle [C]1 Day [D]1), D1 of each cycle until C21, end of treatment (up to Week 103), follow-up (28 days after last dose)]
EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0: worst imaginable health state to 100: best imaginable health state; higher scores indicate a better health state.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Histologically documented metastatic renal cell cancer with a component of clear cell histology.
-
Evidence of measurable disease.
-
Patients with mRCC must have received no prior systemic first-line therapy or must have progressive disease per RECIST (version 1.0) after one prior systemic first line regimen for metastatic disease containing sunitinib, cytokine(s), or both.
Exclusion Criteria:
-
Prior treatment for metastatic renal cell cancer with more that one systemic first line therapy.
-
Major surgery less that 4 weeks or radiation less than 2 weeks of starting study drug.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Advanced Medical Specialties | Miami | Florida | United States | 33143 |
| 2 | Advanced Medical Specialties | Miami | Florida | United States | 33176 |
| 3 | Illinois Cancer Specialists | Arlington Heights | Illinois | United States | 60005 |
| 4 | Illinois Cancer Specialists | Niles | Illinois | United States | 60714 |
| 5 | Indiana University Health Central Indiana Cancer Centers | Carmel | Indiana | United States | 46032 |
| 6 | Indiana University Health Central Indiana Cancer Centers | Fishers | Indiana | United States | 46037 |
| 7 | Indiana University Health Central Indiana Cancer Centers | Greenfield | Indiana | United States | 46140 |
| 8 | Indiana University Health Central Indiana Cancer Centers | Indianapolis | Indiana | United States | 46219 |
| 9 | Indiana University Health Central Indiana Cancer Centers | Indianapolis | Indiana | United States | 46227 |
| 10 | Missouri Cancer Associates | Columbia | Missouri | United States | 65201 |
| 11 | Nebraska Methodist Hospital | Omaha | Nebraska | United States | 68114 |
| 12 | Comprehensive Cancer Centers of Nevada | Henderson | Nevada | United States | 89052 |
| 13 | US Oncology West Region | Henderson | Nevada | United States | 89052 |
| 14 | Comprehensive Cancer Centers of Nevada | Henderson | Nevada | United States | 89074 |
| 15 | Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada | United States | 89128 |
| 16 | Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada | United States | 89148 |
| 17 | Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada | United States | 89169 |
| 18 | Hematology-Oncology Associates of Northern NJ, PA | Morristown | New Jersey | United States | 07962 |
| 19 | Hematology-Oncology Associates of Northern NJ, PA | Parsippany | New Jersey | United States | 07054 |
| 20 | New York Oncology Hematology, PC | Albany | New York | United States | 12206 |
| 21 | New York Oncology Hematology, PC | Albany | New York | United States | 12208 |
| 22 | New York Oncology Hematology, PC | Latham | New York | United States | 12110 |
| 23 | New York Oncology Hematology, PC | Rexford | New York | United States | 12148 |
| 24 | New York Oncology Hematology, PC | Troy | New York | United States | 12180 |
| 25 | Raleigh Hematology Oncology Associates | Cary | North Carolina | United States | 27518 |
| 26 | Raleigh Hematology Oncology Associates | Raleigh | North Carolina | United States | 27607 |
| 27 | Raleigh Hematology Oncology Associates | Raleigh | North Carolina | United States | 27614 |
| 28 | Northwest Cancer Specialists, PC | Portland | Oregon | United States | 97213 |
| 29 | Northwest Cancer Specialists, PC | Portland | Oregon | United States | 97225 |
| 30 | Northwest Cancer Specialists, PC | Portland | Oregon | United States | 97227 |
| 31 | Northwest Cancer Specialists, PC | Tualatin | Oregon | United States | 97062 |
| 32 | Penn State Milton S. Hershey Medical Center, Penn State Cancer Institute | Hershey | Pennsylvania | United States | 17033-0850 |
| 33 | Medical University of South Carolina University Hospital | Charleston | South Carolina | United States | 29425 |
| 34 | Medical University of South Carolina | Charleston | South Carolina | United States | 29425 |
| 35 | Texas Oncology- Amarillo | Amarillo | Texas | United States | 79106 |
| 36 | Texas Oncology-Beaumont, Mamie McFaddin Ward Cancer Center | Beaumont | Texas | United States | 77702-1449 |
| 37 | Texas Oncology- Bedford | Bedford | Texas | United States | 76022 |
| 38 | Texas Oncology- Baylor Charles A. Sammons Cancer Center | Dallas | Texas | United States | 75246 |
| 39 | Texas Oncology- Fort Worth 12th Avenue | Fort Worth | Texas | United States | 76104 |
| 40 | Texas Oncology- Southwest Fort Worth | Fort Worth | Texas | United States | 76132 |
| 41 | Investigational Products Center (lPC) | Fort Worth | Texas | United States | 76177 |
| 42 | US Oncology Research and Clinical Pharmacy | Fort Worth | Texas | United States | 76177 |
| 43 | Texas Oncology - Grapevine | Grapevine | Texas | United States | 76051 |
| 44 | Cancer Care Centers of South Texas | Kerrville | Texas | United States | 78028 |
| 45 | Texas Oncology- McAllen South Second Street | McAllen | Texas | United States | 78503 |
| 46 | Texas Oncology- Midland Allison Cancer Center | Midland | Texas | United States | 79701 |
| 47 | Cancer Care Centers of South Texas | San Antonio | Texas | United States | 78217 |
| 48 | Cancer Care Centers of South Texas | San Antonio | Texas | United States | 78258-3912 |
| 49 | Texas Oncology-Deke Slayton Cancer Center | Webster | Texas | United States | 77598-4420 |
| 50 | Texas Oncology-Weslaco | Weslaco | Texas | United States | 78596 |
| 51 | Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care | Christiansburg | Virginia | United States | 24073 |
| 52 | Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care | Low Moor | Virginia | United States | 24457 |
| 53 | Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care | Roanoke | Virginia | United States | 24014 |
| 54 | Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care | Salem | Virginia | United States | 24153 |
| 55 | Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care | Wytheville | Virginia | United States | 24382 |
| 56 | Northwest Cancer Specialists, PC | Vancouver | Washington | United States | 98684 |
| 57 | Northwest Cancer Specialists, PC | Vancouver | Washington | United States | 98686 |
| 58 | Wenatchee Valley Medical Center | Wenatchee | Washington | United States | 98801 |
| 59 | Clinic of Oncology | Banja Luka | Bosnia and Herzegovina | 78000 | |
| 60 | Institute of Oncology, University Hospital Center Sarajevo | Sarajevo | Bosnia and Herzegovina | 71000 | |
| 61 | University Clinical Center Tuzla, Clinic for Oncology, Hematology and Radiotherapy | Tuzla | Bosnia and Herzegovina | 75000 | |
| 62 | Spetsializirana Bolnitsa za Aktivno Lechenie po Onkologiya, EAD, Klinika po Himioterapiya | Sofia | Bulgaria | 1756 | |
| 63 | SBALOZ D-r Marko Markov-Varna | Varna | Bulgaria | 9000 | |
| 64 | Instituto Clinico Oncologico del Sur | Temuco | Cautin | Chile | 4810469 |
| 65 | Instituto Clinico Oncologico del Sur | Temuco | IX Region | Chile | 4810561 |
| 66 | Instituto de Terapias Oncologicas Providencia | Providencia | Santiago | Chile | 7501088 |
| 67 | Private Office | Santiago | Chile | RM 8360160 | |
| 68 | Cancer Institute and Hospital ,Chinese Academy of Medical Sciences | Beijing | Beijing | China | 100021 |
| 69 | Chinese PLA General Hospital | Haidian District | Beijing | China | 100853 |
| 70 | The Fuzhou General Hospital, PLA Nanjing Military Area Command | Fuzhou | Fujian | China | 350025 |
| 71 | Nanfang Hospital | Guangzhou | Guang DONG | China | 510515 |
| 72 | Urology Department, Sun Yet-Sen University Cancer Center | Guangzhou | Guangdong | China | 510060 |
| 73 | Nanjing Bayi Hospital | Nanjing | Jiangsu | China | 210002 |
| 74 | The Oncology Department, Jiangsu Province Hospital | Nanjing | Jiangsu | China | 210029 |
| 75 | Jilin Provincial Cancer Hospital | Changchun | Jilin | China | 130012 |
| 76 | Urology Department, 1st Hospital of China Medical University | Shen Yang | LIAO NING | China | 110001 |
| 77 | Xijing Hospital, The Fourth Military Medical University,Oncology Department | Xi'an | Shaanxi | China | 710032 |
| 78 | Urology Department, Renji Hospital,Shanghai Jiao Tong University School of Medicine | Shanghai | Shanghai | China | 200127 |
| 79 | West China Hospital of Sichuan University | Chengdu | Sichuan | China | 610041 |
| 80 | Sir Run Run Shaw Hospital of College of Medicine of Zhejiang University, Center for Oncology | Hangzhou | Zhejiang | China | 310016 |
| 81 | Department of Urology,Peking University First Hospital | Beijing | China | 100034 | |
| 82 | Beijing Cancer Hospital/Department of Renal Cancer and Melanoma | Beijing | China | 100036 | |
| 83 | South-Western Hospital, 3rd Military Medical University | Chongqing | China | 400038 | |
| 84 | Jiangsu Cancer Hospital | Nanjing | China | 210009 | |
| 85 | Fudan University, Cancer Hospital, Department of Urology | Shanghai | China | 200032 | |
| 86 | Tianjin Oncology Hospital,biology treatment department | Tianjin | China | 300060 | |
| 87 | Urology Department, The Second Hospital of Tianjin Medical University | Tianjin | China | 300211 | |
| 88 | BIBI General Hospital and Cancer Centre, | Hyderabad | Andhra Pradesh | India | 500024 |
| 89 | Chinmaya Mission Hospital | Bangalore | Karnataka | India | 560038 |
| 90 | Sri Venkateshwara Hospital | Bangalore | Karnataka | India | 560068 |
| 91 | NU Hospitals | Bangalore | Karnataka | India | 560070 |
| 92 | Cancer Care Clinic and Hospitals | Nagpur | Maharashtra | India | 440012 |
| 93 | Shatabdi Superspeciality Hospital | Nashik | Maharashtra | India | 422 005 |
| 94 | Curie Manavata Cancer Centre | Nashik | Maharashtra | India | 422004 |
| 95 | Deenanath Mangeshkar Hospital and Research Centre | Pune | Maharashtra | India | 411 004 |
| 96 | Sahyadri Speciality Hospital | Pune | Maharashtra | India | 411 004 |
| 97 | Shettys hospital | Bangalore | India | 560068 | |
| 98 | University Malaya Medical Centre | Kuala Lumpur | Malaysia | 59100 | |
| 99 | Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran | Mexico | DF | Mexico | 14000 |
| 100 | Hospital General de Mexico O.D. | Mexico City | Distrito Federal | Mexico | 06726 |
| 101 | Centro Hemato-Oncologico Privado | Toluca | Estado DE Mexico | Mexico | 50080 |
| 102 | Centenario Hospital Miguel Hidalgo | Aguascalientes | Mexico | 20000 | |
| 103 | Oaxaca Site Management Organization | Oaxaca | Mexico | 68000 | |
| 104 | Rm. 3227 Doctors Clinic, Annex II Bldg., National Kidney & Transplant Institute | Quezon City | Diliman | Philippines | |
| 105 | St. Lukes Medical Center | Quezon City | Metro Manila | Philippines | 1102 |
| 106 | University of the East Ramon Magsaysay Memorial Medical Center | Quezon City | Metro Manila | Philippines | 1113 |
| 107 | Makati Medical Center | Makati City | Philippines | 1200 | |
| 108 | Room 805, Committee on Research Room, Manila Doctors Hospital | Manila | Philippines | 1000 | |
| 109 | Oncomed SRL | Timisoara | JUD. Timis | Romania | 300239 |
| 110 | Institutul Oncologic "Prof.Dr.I.Chiricuta" Cluj-Napoca | Cluj-Napoca | Romania | 400015 | |
| 111 | Institutul Oncologic ''Prof.Dr. I. Chiricuta'' Cluj Napoca | Cluj-Napoca | Romania | 400015 | |
| 112 | Moscow State Healthcare Institution Oncology Clinical Dispensary #1 | Moscow | Russian Federation | 105005 | |
| 113 | P.A. Herzen Moscow Oncology Research Institute, | Moscow | Russian Federation | 125284 | |
| 114 | GBU RO "Ryazan Regional Clinical Oncology Dispensary" | Ryazan | Russian Federation | 390011 | |
| 115 | FGBOU VO "Ryazan State Medical University named after academician I.P.Pavlov" | Ryazan | Russian Federation | 390026 | |
| 116 | FGBOU VO "First Saint-Petersburg State Medical University n.a. I.P.Pavlov" | Saint-Petersburg | Russian Federation | 197022 | |
| 117 | Republican Clinical Oncology Dispensary of the Ministry of Health of Bashkortostan Republic | Ufa | Russian Federation | 450054 | |
| 118 | GVI Oncology | Port Elizabeth | South Africa | 6045 | |
| 119 | Taichung Veterans General Hospital | Taichung | Taiwan | 407 | |
| 120 | Taipei Veterans General Hospital | Taipei | Taiwan | 112 | |
| 121 | KP Dnipropetrovska oblasna klinichna likarnia im. I.I. Mechnykova" Dnipropetrovskoi oblasnoi rady, | Dnipro | Ukraine | 49005 | |
| 122 | Komunalne nekomertsiine pidpryiemstvo Kharkivskoi oblasnoi rady Oblasnyi medychnyi klinichnyi tsentr | Kharkiv | Ukraine | 61037 | |
| 123 | DU Instytut Urolohii NAMN Ukrainy, viddil onkourolohii, KNP Kyivskyi miskyi klinichnyi onkolohichnyi | Kyiv | Ukraine | 03115 | |
| 124 | Komunalne nekomertsiine pidpryiemstvo Lvivskoi oblasnoi rady Lvivskyi onkolohichnyi rehionalnyi | Lviv | Ukraine | 79031 | |
| 125 | SI "Zaporizhzhya Medical Academy of Postgraduate Education of the Ministry of Health of Ukraine" | Zaporizhzhya | Ukraine | 69040 |
Sponsors and Collaborators
- Pfizer
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Pfizer
ClinicalTrials.gov Identifier:
NCT00920816
Other Study ID Numbers:
- A4061051
- 2010-018585-23
First Posted:
Jun 15, 2009
Last Update Posted:
May 6, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Keywords provided by Pfizer
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | First-line participants included all treatment-naive participants with metastatic renal cell cancer (mRCC) from global and second-line participants included all previously-treated Asian participants with mRCC. |
|---|---|
| Pre-assignment Detail | All China participants were excluded from safety analysis due to inability to obtain timely approval to use data in accordance with Human Genetic Resources Administration of China (HGRAC) regulation. |
| Arm/Group Title | Axitinib (First-line Participants) | Sorafenib (First-line Participants) | Axitinib (Second-line Participants) | Sorafenib (Second-line Participants) |
|---|---|---|---|---|
| Arm/Group Description | Participants with no prior systemic first-line therapy received axitinib (AG-013736) tablet at a starting dose of 5 milligram (mg) orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks. | Participants with no prior systemic first-line therapy received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks. | Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks. | Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks. |
| Period Title: Overall Study | ||||
| STARTED | 192 | 96 | 135 | 69 |
| Treated | 189 | 96 | 135 | 69 |
| Participants From China (Excluded From Safety Analysis) | 16 | 8 | 124 | 64 |
| COMPLETED | 0 | 0 | 0 | 0 |
| NOT COMPLETED | 192 | 96 | 135 | 69 |
Baseline Characteristics
| Arm/Group Title | Axitinib (First-line Participants) | Sorafenib (First-line Participants) | Axitinib (Second-line Participants) | Sorafenib (Second-line Participants) | Total |
|---|---|---|---|---|---|
| Arm/Group Description | Participants with no prior systemic first-line therapy received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks. | Participants with no prior systemic first-line therapy received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks. | Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks. | Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks. | Total of all reporting groups |
| Overall Participants | 192 | 96 | 135 | 69 | 492 |
| Age, Customized (Count of Participants) | |||||
| Less than (<) 65 years |
142
74%
|
77
80.2%
|
110
81.5%
|
56
81.2%
|
385
78.3%
|
| Greater than or equal to (>=) 65 years |
50
26%
|
19
19.8%
|
25
18.5%
|
13
18.8%
|
107
21.7%
|
| Sex: Female, Male (Count of Participants) | |||||
| Female |
58
30.2%
|
22
22.9%
|
41
30.4%
|
20
29%
|
141
28.7%
|
| Male |
134
69.8%
|
74
77.1%
|
94
69.6%
|
49
71%
|
351
71.3%
|
Outcome Measures
| Title | Progression Free Survival (PFS): First-Line Participants |
|---|---|
| Description | Time in months from randomization to first documentation of objective tumor progression or death due to any cause. PFS calculated as (first event date minus date of randomization plus 1)/30.4. Tumor progression determined from oncologic assessment data (where it meets criteria for progressive disease [PD]), or from adverse event (AE) data (where outcome was "Death"). Progression using Response Evaluation Criteria in Solid Tumors (RECIST) is >= 20 percent (%) increase in sum of longest diameter of target lesions; measurable increase in non-target lesion; appearance of new lesions. |
| Time Frame | Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 107) |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS included all treatment-naive participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug, or received a different drug from that to which they were randomized. |
| Arm/Group Title | Axitinib (First-line Participants) | Sorafenib (First-line Participants) |
|---|---|---|
| Arm/Group Description | Participants with no prior systemic first-line therapy received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks. | Participants with no prior systemic first-line therapy received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks. |
| Measure Participants | 192 | 96 |
| Median (95% Confidence Interval) [months] |
10.1
|
6.5
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Axitinib (First-line Participants), Sorafenib (First-line Participants) |
|---|---|---|
| Comments | First-line participants: hazard ratio was stratified by eastern cooperative oncology group (ECOG) performance status (0 versus 1). | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.767 | |
| Confidence Interval |
(2-Sided) 95% 0.559 to 1.053 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Progression Free Survival (PFS): Second-Line Participants |
|---|---|
| Description | Time in months from randomization to first documentation of objective tumor progression or death due to any cause. PFS calculated as (first event date minus date of randomization plus 1)/30.4. Tumor progression determined from oncologic assessment data (where it meets criteria for progressive disease [PD]), or from adverse event (AE) data (where outcome was "Death"). Progression using Response Evaluation Criteria in Solid Tumors (RECIST) is >= 20 percent (%) increase in sum of longest diameter of target lesions; measurable increase in non-target lesion; appearance of new lesions. |
| Time Frame | Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 103) |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS included all previously-treated Asian participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug, or received a different drug from that to which they were randomized. |
| Arm/Group Title | Axitinib (Second-line Participants) | Sorafenib (Second-line Participants) |
|---|---|---|
| Arm/Group Description | Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks. | Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks. |
| Measure Participants | 135 | 69 |
| Median (95% Confidence Interval) [months] |
6.5
|
4.8
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Axitinib (First-line Participants), Sorafenib (First-line Participants) |
|---|---|---|
| Comments | Second-line participants: hazard ratio was stratified by eastern cooperative oncology group (ECOG) performance status (0 versus 1) and prior treatment (sunitinib versus cytokine-containing regimen). | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.731 | |
| Confidence Interval |
(2-Sided) 95% 0.506 to 1.058 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Percentage of Participants With Objective Response (OR): First-Line Participants |
|---|---|
| Description | Percentage of participants with OR based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST. Confirmed response were those that persisted on repeat imaging study at least 4 weeks after initial documentation of response. CR was defined as disappearance of all lesions (target and/or non target). PR were those with at least 30 percent decrease in sum of the longest dimensions of target lesions taking as a reference the baseline sum longest dimensions, with non target lesions not increased or absent. |
| Time Frame | Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 107) |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS included all treatment-naive participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug, or received a different drug from that to which they were randomized. |
| Arm/Group Title | Axitinib (First-line Participants) | Sorafenib (First-line Participants) |
|---|---|---|
| Arm/Group Description | Participants with no prior systemic first-line therapy received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks. | Participants with no prior systemic first-line therapy received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks. |
| Measure Participants | 192 | 96 |
| Number (95% Confidence Interval) [percentage of participants] |
32.3
16.8%
|
14.6
15.2%
|
| Title | Percentage of Participants With Objective Response (OR): Second-Line Participants |
|---|---|
| Description | Percentage of participants with OR based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST. Confirmed response were those that persisted on repeat imaging study at least 4 weeks after initial documentation of response. CR was defined as disappearance of all lesions (target and/or non target). PR were those with at least 30 percent decrease in sum of the longest dimensions of target lesions taking as a reference the baseline sum longest dimensions, with non target lesions not increased or absent. |
| Time Frame | Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 103) |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS included all previously-treated Asian participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug, or received a different drug from that to which they were randomized. |
| Arm/Group Title | Axitinib (Second-line Participants) | Sorafenib (Second-line Participants) |
|---|---|---|
| Arm/Group Description | Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks. | Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks. |
| Measure Participants | 135 | 69 |
| Number (95% Confidence Interval) [percentage of participants] |
23.7
12.3%
|
10.1
10.5%
|
| Title | Duration of Response (DR): First-Line Participants |
|---|---|
| Description | Time in months from the first documentation of objective tumor response that is subsequently confirmed to objective tumor progression or death due to any cause. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to any cause minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 30.4. DR was calculated for the subgroup of participants with a confirmed objective tumor response. |
| Time Frame | Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 107) |
Outcome Measure Data
| Analysis Population Description |
|---|
| DR was calculated for the subgroup of participants from the FAS treatment-naive population, with a confirmed objective tumor response (CR or PR). |
| Arm/Group Title | Axitinib (First-line Participants) | Sorafenib (First-line Participants) |
|---|---|---|
| Arm/Group Description | Participants with no prior systemic first-line therapy received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks. | Participants with no prior systemic first-line therapy received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks. |
| Measure Participants | 62 | 14 |
| Median (95% Confidence Interval) [months] |
14.7
|
14.3
|
| Title | Duration of Response (DR): Second-Line Participants |
|---|---|
| Description | Time in months from the first documentation of objective tumor response that is subsequently confirmed to objective tumor progression or death due to any cause. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to any cause minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 30.4. DR was calculated for the subgroup of participants with a confirmed objective tumor response. |
| Time Frame | Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 103) |
Outcome Measure Data
| Analysis Population Description |
|---|
| DR was calculated for the subgroup of participants from the FAS previously-treated population, with a confirmed objective tumor response (CR or PR). |
| Arm/Group Title | Axitinib (Second-line Participants) | Sorafenib (Second-line Participants) |
|---|---|---|
| Arm/Group Description | Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks. | Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks. |
| Measure Participants | 32 | 7 |
| Median (95% Confidence Interval) [months] |
NA
|
8.7
|
| Title | Overall Survival (OS): First-Line Participants |
|---|---|
| Description | Time in months from date of randomization to date of death due to any cause. OS was calculated as (the death date minus the date of randomization plus 1) divided by 30.4. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death). |
| Time Frame | Baseline until death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 107) |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS included all treatment-naive participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug, or received a different drug from that to which they were randomized. |
| Arm/Group Title | Axitinib (First-line Participants) | Sorafenib (First-line Participants) |
|---|---|---|
| Arm/Group Description | Participants with no prior systemic first-line therapy received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks. | Participants with no prior systemic first-line therapy received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks. |
| Measure Participants | 192 | 96 |
| Median (95% Confidence Interval) [months] |
NA
|
NA
|
| Title | Overall Survival (OS): Second-Line Participants |
|---|---|
| Description | Time in months from date of randomization to date of death due to any cause. OS was calculated as (the death date minus the date of randomization plus 1) divided by 30.4. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death). |
| Time Frame | Baseline until death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 103) |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS included all previously-treated Asian participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug, or received a different drug from that to which they were randomized. |
| Arm/Group Title | Axitinib (Second-line Participants) | Sorafenib (Second-line Participants) |
|---|---|---|
| Arm/Group Description | Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks. | Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks. |
| Measure Participants | 135 | 69 |
| Median (95% Confidence Interval) [months] |
17.2
|
18.1
|
| Title | Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): First-Line Participants |
|---|---|
| Description | FKSI-15 questionnaires (lack of energy, side effects, pain, weight loss, bone pain, fatigue, enjoying life, short of breath, worsened condition, appetite, coughing, bothered by fevers, ability to work, hematuria, sleep) was used to assess quality of life (QoL) for those diagnosed with renal cell cancer. Questions answered on 5-point Likert scale: 0 to 4 (0= not at all, 1= little bit, 2= somewhat, 3= quite a bit, 4= very much). Total FKSI score 0 to 60; higher scores=better health states (Individual questions may be reversed coded, as appropriate). |
| Time Frame | Baseline (Pre-dose on Cycle [C]1 Day [D]1), D1 of each cycle until C23, end of treatment (up to Week 107), follow-up (28 days after last dose) |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS treatment-naive population. Here 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure and 'number analyzed' signifies those participants evaluated for this measure at specific time point for each group respectively. |
| Arm/Group Title | Axitinib (First-line Participants) | Sorafenib (First-line Participants) |
|---|---|---|
| Arm/Group Description | Participants with no prior systemic first-line therapy received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks. | Participants with no prior systemic first-line therapy received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks. |
| Measure Participants | 183 | 95 |
| C1 D1 |
43.869
(8.117)
|
43.865
(6.723)
|
| C2 D1 |
43.328
(7.630)
|
43.969
(6.286)
|
| C3 D1 |
43.366
(7.192)
|
43.345
(6.878)
|
| C4 D1 |
42.932
(7.566)
|
42.926
(7.324)
|
| C5 D1 |
43.211
(7.578)
|
44.022
(6.714)
|
| C6 D1 |
42.787
(8.098)
|
42.344
(6.685)
|
| C7 D1 |
42.474
(7.926)
|
43.446
(6.931)
|
| C8 D1 |
42.534
(7.510)
|
44.077
(6.986)
|
| C9 D1 |
42.778
(8.229)
|
44.051
(7.234)
|
| C10 D1 |
43.120
(7.966)
|
44.018
(6.751)
|
| C11 D1 |
43.264
(7.837)
|
45.000
(6.130)
|
| C12 D1 |
43.962
(7.243)
|
45.318
(6.440)
|
| C13 D1 |
44.141
(7.289)
|
45.787
(6.526)
|
| C14 D1 |
43.789
(7.985)
|
45.459
(6.535)
|
| C15 D1 |
44.176
(8.055)
|
45.514
(5.914)
|
| C16 D1 |
44.232
(7.515)
|
46.000
(5.651)
|
| C17 D1 |
43.897
(8.456)
|
46.400
(6.262)
|
| C18 D1 |
43.761
(8.019)
|
45.357
(6.983)
|
| C19 D1 |
43.737
(7.413)
|
45.583
(7.366)
|
| C20 D1 |
43.733
(7.605)
|
44.333
(7.066)
|
| C21 D1 |
45.417
(6.240)
|
43.500
(7.687)
|
| C22 D1 |
47.000
(5.985)
|
45.833
(5.937)
|
| C23 D1 |
47.571
(6.357)
|
45.714
(6.651)
|
| End of treatment |
39.052
(9.109)
|
39.524
(8.896)
|
| Follow-up |
39.683
(11.132)
|
40.038
(9.897)
|
| Title | Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): Second-Line Participants |
|---|---|
| Description | FKSI-15 questionnaires (lack of energy, side effects, pain, weight loss, bone pain, fatigue, enjoying life, short of breath, worsened condition, appetite, coughing, bothered by fevers, ability to work, hematuria, sleep) was used to assess quality of life (QoL) for those diagnosed with renal cell cancer. Questions answered on 5-point Likert scale: 0 to 4 (0= not at all, 1= little bit, 2= somewhat, 3= quite a bit, 4= very much). Total FKSI score 0 to 60; higher scores=better health states (Individual questions may be reversed coded, as appropriate). |
| Time Frame | Baseline (Pre-dose on Cycle [C]1 Day [D]1), D1 of each cycle until C21, end of treatment (up to Week 103), follow-up (28 days after last dose) |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS previously-treated Asian population. Here 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure and 'number analyzed' signifies those participants evaluated for this measure at specific time point for each group respectively. |
| Arm/Group Title | Axitinib (Second-line Participants) | Sorafenib (Second-line Participants) |
|---|---|---|
| Arm/Group Description | Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks. | Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks. |
| Measure Participants | 134 | 69 |
| C1 D1 |
46.753
(6.692)
|
47.470
(7.450)
|
| C2 D1 |
46.217
(7.028)
|
45.045
(7.478)
|
| C3 D1 |
45.968
(7.237)
|
45.684
(7.756)
|
| C4 D1 |
45.060
(8.040)
|
45.792
(7.762)
|
| C5 D1 |
45.775
(7.797)
|
46.125
(7.491)
|
| C6 D1 |
45.407
(7.274)
|
46.341
(7.213)
|
| C7 D1 |
45.709
(8.263)
|
45.053
(7.843)
|
| C8 D1 |
45.169
(7.609)
|
45.676
(9.357)
|
| C9 D1 |
45.829
(7.442)
|
45.970
(8.487)
|
| C10 D1 |
45.608
(8.299)
|
46.148
(8.156)
|
| C11 D1 |
45.833
(7.599)
|
47.227
(6.611)
|
| C12 D1 |
45.797
(6.967)
|
48.091
(6.414)
|
| C13 D1 |
46.727
(7.307)
|
47.600
(5.762)
|
| C14 D1 |
47.740
(7.094)
|
49.133
(5.235)
|
| C15 D1 |
48.023
(6.297)
|
49.308
(4.111)
|
| C16 D1 |
48.184
(6.186)
|
50.500
(3.989)
|
| C17 D1 |
47.909
(6.866)
|
49.000
(5.869)
|
| C18 D1 |
48.138
(6.791)
|
49.125
(5.139)
|
| C19 D1 |
48.636
(5.206)
|
48.571
(7.458)
|
| C20 D1 |
48.810
(6.478)
|
50.500
(4.637)
|
| C21 D1 |
50.188
(5.588)
|
50.000
(5.177)
|
| End of treatment |
41.432
(9.188)
|
42.889
(8.846)
|
| Follow-up |
35.385
(7.795)
|
38.583
(11.556)
|
| Title | Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): First-Line Participants |
|---|---|
| Description | FKSI-DRS: subset of FKSI which is FACT-Kidney Symptom Index questionnaire used to assess QoL for participants diagnosed with renal cell cancer. FKSI contains 15 questions and FKSI-DRS 9 questions (lack of energy, pain, losing weight, bone pain, fatigue, short of breath, coughing, bothered by fevers, hematuria) each ranging from 0 (not at all) to 4 (very much). FKSI-DRS total score 0 to 36; higher scores associated with better health states (Individual questions may be reversed coded, as appropriate). |
| Time Frame | Baseline (Pre-dose on Cycle [C]1 Day [D]1), D1 of each cycle until C23, end of treatment (up to Week 107), follow-up (28 days after last dose) |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS treatment-naive population. Here 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure and 'number analyzed' signifies those participants evaluated for this measure at specific time point for each group respectively. |
| Arm/Group Title | Axitinib (First-line Participants) | Sorafenib (First-line Participants) |
|---|---|---|
| Arm/Group Description | Participants with no prior systemic first-line therapy received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks. | Participants with no prior systemic first-line therapy received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks. |
| Measure Participants | 183 | 95 |
| C1 D1 |
28.691
(5.392)
|
29.653
(4.699)
|
| C2 D1 |
28.728
(4.581)
|
29.963
(3.817)
|
| C3 D1 ( |
29.171
(4.093)
|
29.750
(4.095)
|
| C4 D1 |
28.577
(4.305)
|
29.642
(4.244)
|
| C5 D1 |
29.020
(4.257)
|
30.255
(3.668)
|
| C6 D1 |
28.574
(4.674)
|
29.153
(4.009)
|
| C7 D1 |
28.568
(4.548)
|
29.523
(4.051)
|
| C8 D1 |
28.557
(4.308)
|
30.296
(3.890)
|
| C9 D1 |
28.817
(4.665)
|
30.186
(4.392)
|
| C10 D1 |
29.057
(4.484)
|
30.364
(4.143)
|
| C11 D1 |
29.146
(4.207)
|
30.688
(3.926)
|
| C12 D1 |
29.648
(3.752)
|
30.727
(3.896)
|
| C13 D1 |
29.545
(4.056)
|
31.483
(3.602)
|
| C14 D1 |
29.579
(4.186)
|
31.027
(3.790)
|
| C15 D1 |
29.859
(4.438)
|
30.730
(3.724)
|
| C16 D1 |
29.683
(4.242)
|
31.515
(3.242)
|
| C17 D1 |
29.564
(4.695)
|
31.567
(3.884)
|
| C18 D1 |
29.380
(4.752)
|
31.107
(4.425)
|
| C19 D1 |
29.737
(4.414)
|
31.417
(3.911)
|
| C20 D1 |
29.844
(4.527)
|
30.762
(4.122)
|
| C21 D1 |
30.889
(3.115)
|
30.056
(4.372)
|
| C22 D1 |
31.696
(3.081)
|
31.000
(3.275)
|
| C23 D1 |
31.357
(3.388)
|
31.143
(4.413)
|
| End of treatment |
26.556
(5.487)
|
26.786
(5.982)
|
| Follow-up |
26.805
(6.373)
|
26.769
(6.095)
|
| Title | Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): Second-Line Participants |
|---|---|
| Description | FKSI-DRS: subset of FKSI which is FACT-Kidney Symptom Index questionnaire used to assess QoL for participants diagnosed with renal cell cancer. FKSI contains 15 questions and FKSI-DRS 9 questions (lack of energy, pain, losing weight, bone pain, fatigue, short of breath, coughing, bothered by fevers, hematuria) each ranging from 0 (not at all) to 4 (very much). FKSI-DRS total score 0 to 36; higher scores associated with better health states (Individual questions may be reversed coded, as appropriate). |
| Time Frame | Baseline (Pre-dose on Cycle [C]1 Day [D]1), D1 of each cycle until C21, end of treatment (up to Week 103), follow-up (28 days after last dose) |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS previously-treated Asian population. Here 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure and 'number analyzed' signifies those participants evaluated for this measure at specific time point for each group respectively. |
| Arm/Group Title | Axitinib (Second-line Participants) | Sorafenib (Second-line Participants) |
|---|---|---|
| Arm/Group Description | Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks. | Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks. |
| Measure Participants | 134 | 69 |
| C1 D1 |
31.020
(3.986)
|
31.489
(4.538)
|
| C2 D1 |
30.600
(3.892)
|
30.682
(3.895)
|
| C3 D1 |
30.645
(3.681)
|
30.965
(3.803)
|
| C4 D1 |
30.103
(4.558)
|
30.679
(3.980)
|
| C5 D1 |
30.676
(4.271)
|
31.063
(3.629)
|
| C6 D1 |
30.731
(3.973)
|
31.439
(4.249)
|
| C7 D1 |
30.920
(4.373)
|
30.632
(4.365)
|
| C8 D1 |
30.966
(4.144)
|
30.703
(5.195)
|
| C9 D1 |
31.012
(3.783)
|
30.667
(4.884)
|
| C10 D1 |
30.986
(4.133)
|
30.926
(4.215)
|
| C11 D1 |
31.212
(4.033)
|
32.045
(3.579)
|
| C12 D1 |
31.356
(3.443)
|
32.000
(3.338)
|
| C13 D1 |
31.418
(3.775)
|
32.100
(2.989)
|
| C14 D1 |
32.100
(3.321)
|
32.800
(2.274)
|
| C15 D1 |
32.000
(2.861)
|
32.769
(2.279)
|
| C16 D1 |
31.921
(3.372)
|
33.167
(2.167)
|
| C17 D1 |
32.061
(3.344)
|
32.800
(2.898)
|
| C18 D1 |
31.931
(3.116)
|
32.625
(2.615)
|
| C19 D1 |
32.364
(2.341)
|
32.429
(4.429)
|
| C20 D1 |
31.905
(2.998)
|
33.500
(2.168)
|
| C21 D1 |
33.125
(2.473)
|
33.500
(2.345)
|
| End of treatment |
28.216
(5.662)
|
29.519
(4.661)
|
| Follow-up |
24.692
(4.366)
|
27.500
(6.762)
|
| Title | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: First-Line Participants |
|---|---|
| Description | EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. |
| Time Frame | Baseline (Pre-dose on Cycle [C]1 Day [D]1), D1 of each cycle until C23, end of treatment (up to Week 107), follow-up (28 days after last dose) |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS treatment-naive population. Here 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure and 'number analyzed' signifies those participants evaluated for this measure at specific time point for each group respectively. |
| Arm/Group Title | Axitinib (First-line Participants) | Sorafenib (First-line Participants) |
|---|---|---|
| Arm/Group Description | Participants with no prior systemic first-line therapy received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks. | Participants with no prior systemic first-line therapy received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks. |
| Measure Participants | 183 | 94 |
| C1 D1 |
0.710
(0.254)
|
0.712
(0.272)
|
| C2 D1 |
0.709
(0.214)
|
0.693
(0.237)
|
| C3 D1 |
0.694
(0.251)
|
0.687
(0.261)
|
| C4 D1 |
0.696
(0.235)
|
0.668
(0.265)
|
| C5 D1 |
0.708
(0.221)
|
0.673
(0.269)
|
| C6 D1 |
0.683
(0.263)
|
0.641
(0.281)
|
| C7 D1 |
0.685
(0.225)
|
0.676
(0.255)
|
| C8 D1 |
0.678
(0.274)
|
0.717
(0.244)
|
| C9 D1 |
0.704
(0.239)
|
0.729
(0.202)
|
| C10 D1 |
0.682
(0.277)
|
0.723
(0.238)
|
| C11 D1 |
0.698
(0.260)
|
0.748
(0.199)
|
| C12 D1 |
0.708
(0.227)
|
0.742
(0.218)
|
| C13 D1 |
0.708
(0.253)
|
0.761
(0.220)
|
| C14 D1 |
0.703
(0.260)
|
0.731
(0.254)
|
| C15 D1 |
0.689
(0.269)
|
0.755
(0.225)
|
| C16 D1 |
0.702
(0.244)
|
0.775
(0.186)
|
| C17 D1 |
0.706
(0.250)
|
0.738
(0.250)
|
| C18 D1 |
0.699
(0.259)
|
0.777
(0.191)
|
| C19 D1 |
0.713
(0.256)
|
0.762
(0.261)
|
| C20 D1 |
0.699
(0.261)
|
0.710
(0.300)
|
| C21 D1 |
0.712
(0.232)
|
0.702
(0.307)
|
| C22 D1 |
0.737
(0.255)
|
0.774
(0.177)
|
| C23 D1 |
0.736
(0.275)
|
0.789
(0.187)
|
| End of treatment |
0.635
(0.268)
|
0.588
(0.291)
|
| Follow-up |
0.545
(0.434)
|
0.618
(0.254)
|
| Title | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: Second-Line Participants |
|---|---|
| Description | EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. |
| Time Frame | Baseline (Pre-dose on Cycle [C]1 Day [D]1), D1 of each cycle until C21, end of treatment (up to Week 103), follow-up (28 days after last dose) |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS previously-treated Asian population. Here 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure and 'number analyzed' signifies those participants evaluated for this measure at specific time point for each group respectively. |
| Arm/Group Title | Axitinib (Second-line Participants) | Sorafenib (Second-line Participants) |
|---|---|---|
| Arm/Group Description | Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks. | Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks. |
| Measure Participants | 134 | 69 |
| C1 D1 |
0.812
(0.225)
|
0.831
(0.186)
|
| C2 D1 |
0.769
(0.218)
|
0.754
(0.251)
|
| C3 D1 |
0.772
(0.206)
|
0.755
(0.278)
|
| C4 D1 |
0.737
(0.272)
|
0.759
(0.211)
|
| C5 D1 |
0.780
(0.203)
|
0.768
(0.275)
|
| C6 D1 |
0.767
(0.251)
|
0.753
(0.245)
|
| C7 D1 |
0.762
(0.252)
|
0.768
(0.239)
|
| C8 D1 |
0.758
(0.241)
|
0.733
(0.339)
|
| C9 D1 |
0.796
(0.203)
|
0.794
(0.262)
|
| C10 D1 |
0.768
(0.243)
|
0.820
(0.169)
|
| C11 D1 |
0.792
(0.210)
|
0.848
(0.158)
|
| C12 D1 |
0.797
(0.201)
|
0.837
(0.157)
|
| C13 D1 |
0.786
(0.217)
|
0.814
(0.156)
|
| C14 D1 |
0.833
(0.162)
|
0.871
(0.131)
|
| C15 D1 |
0.819
(0.151)
|
0.829
(0.152)
|
| C16 D1 |
0.811
(0.186)
|
0.828
(0.142)
|
| C17 D1 |
0.834
(0.158)
|
0.865
(0.122)
|
| C18 D1 |
0.830
(0.164)
|
0.829
(0.160)
|
| C19 D1 |
0.830
(0.148)
|
0.861
(0.139)
|
| C20 D1 |
0.832
(0.163)
|
0.923
(0.129)
|
| C21 D1 |
0.859
(0.155)
|
0.852
(0.176)
|
| End of treatment |
0.582
(0.406)
|
0.623
(0.296)
|
| Follow-up |
0.429
(0.358)
|
0.418
(0.565)
|
| Title | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): First-Line Participants |
|---|---|
| Description | EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0: worst imaginable health state to 100: best imaginable health state; higher scores indicate a better health state. |
| Time Frame | Baseline (Pre-dose on Cycle [C]1 Day [D]1), D1 of each cycle until C23, end of treatment (up to Week 107), follow-up (28 days after last dose) |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS treatment-naive population. Here 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure and 'number analyzed' signifies those participants evaluated for this measure at specific time point for each group respectively. |
| Arm/Group Title | Axitinib (First-line Participants) | Sorafenib (First-line Participants) |
|---|---|---|
| Arm/Group Description | Participants with no prior systemic first-line therapy received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks. | Participants with no prior systemic first-line therapy received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks. |
| Measure Participants | 182 | 94 |
| C1 D1 |
71.181
(19.641)
|
72.362
(16.466)
|
| C2 D1 |
71.714
(16.583)
|
72.422
(14.576)
|
| C3 D1 |
72.006
(16.971)
|
71.241
(16.252)
|
| C4 D1 |
72.179
(16.980)
|
72.086
(14.904)
|
| C5 D1 |
72.451
(18.237)
|
73.615
(14.665)
|
| C6 D1 |
71.574
(18.929)
|
69.944
(17.535)
|
| C7 D1 |
71.050
(18.967)
|
73.923
(13.998)
|
| C8 D1 |
71.031
(19.081)
|
73.183
(16.674)
|
| C9 D1 |
72.690
(18.789)
|
73.780
(16.180)
|
| C10 D1 |
72.910
(19.354)
|
72.400
(18.814)
|
| C11 D1 |
72.763
(18.174)
|
72.271
(18.512)
|
| C12 D1 |
73.610
(18.275)
|
75.295
(17.052)
|
| C13 D1 |
73.030
(18.348)
|
75.432
(17.907)
|
| C14 D1 |
73.147
(17.546)
|
75.108
(18.371)
|
| C15 D1 |
74.494
(17.938)
|
74.405
(17.650)
|
| C16 D1 |
73.878
(18.289)
|
75.818
(17.716)
|
| C17 D1 |
73.090
(17.717)
|
74.333
(18.654)
|
| C18 D1 |
73.817
(17.288)
|
75.571
(18.550)
|
| C19 D1 |
72.089
(18.169)
|
75.125
(20.919)
|
| C20 D1 |
74.244
(17.044)
|
74.190
(20.425)
|
| C21 D1 |
75.694
(11.918)
|
70.500
(21.637)
|
| C22 D1 |
78.000
(12.544)
|
73.917
(15.900)
|
| C23 D1 |
77.143
(12.697)
|
72.571
(14.820)
|
| End of treatment |
67.254
(19.495)
|
67.048
(22.570)
|
| Follow-up |
69.195
(20.366)
|
64.885
(19.916)
|
| Title | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): Second-Line Participants |
|---|---|
| Description | EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0: worst imaginable health state to 100: best imaginable health state; higher scores indicate a better health state. |
| Time Frame | Baseline (Pre-dose on Cycle [C]1 Day [D]1), D1 of each cycle until C21, end of treatment (up to Week 103), follow-up (28 days after last dose) |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS previously-treated Asian population. Here 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure and 'number analyzed' signifies those participants evaluated for this measure at specific time point for each group respectively. |
| Arm/Group Title | Axitinib (Second-line Participants) | Sorafenib (Second-line Participants) |
|---|---|---|
| Arm/Group Description | Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks. | Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks. |
| Measure Participants | 134 | 69 |
| C1 D1 |
82.799
(13.351)
|
82.058
(14.021)
|
| C2 D1 |
81.102
(13.895)
|
78.231
(15.823)
|
| C3 D1 |
80.895
(13.387)
|
80.534
(16.453)
|
| C4 D1 |
81.138
(13.508)
|
81.245
(14.590)
|
| C5 D1 |
83.018
(12.829)
|
80.250
(15.495)
|
| C6 D1 |
82.222
(13.793)
|
80.829
(15.091)
|
| C7 D1 |
82.900
(13.287)
|
80.868
(16.140)
|
| C8 D1 |
83.382
(12.636)
|
81.000
(14.606)
|
| C9 D1 |
84.171
(11.260)
|
83.788
(10.349)
|
| C10 D1 |
83.041
(13.042)
|
82.778
(11.440)
|
| C11 D1 |
84.136
(14.231)
|
83.000
(11.832)
|
| C12 D1 |
84.305
(13.211)
|
83.500
(12.188)
|
| C13 D1 |
82.927
(17.317)
|
83.300
(11.263)
|
| C14 D1 |
86.520
(10.831)
|
86.667
(8.715)
|
| C15 D1 |
85.841
(11.783)
|
86.462
(8.678)
|
| C16 D1 |
87.579
(10.391)
|
86.083
(8.816)
|
| C17 D1 |
88.424
(10.866)
|
84.300
(10.328)
|
| C18 D1 |
86.586
(13.605)
|
83.125
(8.839)
|
| C19 D1 |
89.500
(8.684)
|
82.143
(11.495)
|
| C20 D1 |
90.333
(8.679)
|
86.000
(9.695)
|
| C21 D1 |
90.313
(9.741)
|
84.167
(9.704)
|
| End of treatment |
75.568
(17.934)
|
74.741
(17.623)
|
| Follow-up |
58.154
(20.760)
|
64.333
(25.564)
|
Adverse Events
| Time Frame | ||||||||
|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received. | |||||||
| Arm/Group Title | Axitinib (First-line Participants) | Sorafenib (First-line Participants) | Axitinib (Second-line Participants) | Sorafenib (Second-line Participants) | ||||
| Arm/Group Description | Participants with no prior systemic first-line therapy received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks. | Participants with no prior systemic first-line therapy received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks. | Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks. | Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks. | ||||
All Cause Mortality |
||||||||
| Axitinib (First-line Participants) | Sorafenib (First-line Participants) | Axitinib (Second-line Participants) | Sorafenib (Second-line Participants) | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 117/173 (67.6%) | 63/88 (71.6%) | 9/11 (81.8%) | 3/5 (60%) | ||||
Serious Adverse Events |
||||||||
| Axitinib (First-line Participants) | Sorafenib (First-line Participants) | Axitinib (Second-line Participants) | Sorafenib (Second-line Participants) | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 77/173 (44.5%) | 26/88 (29.5%) | 6/11 (54.5%) | 3/5 (60%) | ||||
| Blood and lymphatic system disorders | ||||||||
| Anaemia | 0/173 (0%) | 1/88 (1.1%) | 3/11 (27.3%) | 1/5 (20%) | ||||
| Thrombocytopenia | 1/173 (0.6%) | 0/88 (0%) | 0/11 (0%) | 0/5 (0%) | ||||
| Cardiac disorders | ||||||||
| Angina pectoris | 1/173 (0.6%) | 0/88 (0%) | 0/11 (0%) | 0/5 (0%) | ||||
| Myocardial infarction | 3/173 (1.7%) | 2/88 (2.3%) | 0/11 (0%) | 0/5 (0%) | ||||
| Myocardial ischaemia | 1/173 (0.6%) | 0/88 (0%) | 0/11 (0%) | 0/5 (0%) | ||||
| Acute myocardial infarction | 1/173 (0.6%) | 2/88 (2.3%) | 1/11 (9.1%) | 0/5 (0%) | ||||
| Atrial flutter | 1/173 (0.6%) | 0/88 (0%) | 0/11 (0%) | 0/5 (0%) | ||||
| Cardiac arrest | 3/173 (1.7%) | 0/88 (0%) | 0/11 (0%) | 0/5 (0%) | ||||
| Cardio-respiratory arrest | 2/173 (1.2%) | 0/88 (0%) | 0/11 (0%) | 1/5 (20%) | ||||
| Atrioventricular block second degree | 1/173 (0.6%) | 0/88 (0%) | 0/11 (0%) | 0/5 (0%) | ||||
| Ischaemic cardiomyopathy | 0/173 (0%) | 0/88 (0%) | 1/11 (9.1%) | 0/5 (0%) | ||||
| Gastrointestinal disorders | ||||||||
| Abdominal pain | 1/173 (0.6%) | 3/88 (3.4%) | 2/11 (18.2%) | 1/5 (20%) | ||||
| Anal fistula | 1/173 (0.6%) | 0/88 (0%) | 0/11 (0%) | 1/5 (20%) | ||||
| Diarrhoea | 8/173 (4.6%) | 2/88 (2.3%) | 1/11 (9.1%) | 0/5 (0%) | ||||
| Gastritis | 1/173 (0.6%) | 0/88 (0%) | 1/11 (9.1%) | 0/5 (0%) | ||||
| Oesophagitis | 0/173 (0%) | 0/88 (0%) | 1/11 (9.1%) | 0/5 (0%) | ||||
| Upper gastrointestinal haemorrhage | 1/173 (0.6%) | 0/88 (0%) | 1/11 (9.1%) | 0/5 (0%) | ||||
| Abdominal distension | 1/173 (0.6%) | 0/88 (0%) | 0/11 (0%) | 0/5 (0%) | ||||
| Gastric haemorrhage | 0/173 (0%) | 1/88 (1.1%) | 0/11 (0%) | 0/5 (0%) | ||||
| Gastric ulcer | 1/173 (0.6%) | 0/88 (0%) | 0/11 (0%) | 0/5 (0%) | ||||
| Gastrointestinal haemorrhage | 1/173 (0.6%) | 0/88 (0%) | 0/11 (0%) | 0/5 (0%) | ||||
| Impaired gastric emptying | 1/173 (0.6%) | 0/88 (0%) | 0/11 (0%) | 0/5 (0%) | ||||
| Melaena | 1/173 (0.6%) | 0/88 (0%) | 0/11 (0%) | 0/5 (0%) | ||||
| Nausea | 1/173 (0.6%) | 1/88 (1.1%) | 0/11 (0%) | 0/5 (0%) | ||||
| Oesophageal varices haemorrhage | 1/173 (0.6%) | 0/88 (0%) | 0/11 (0%) | 0/5 (0%) | ||||
| Peptic ulcer | 1/173 (0.6%) | 0/88 (0%) | 0/11 (0%) | 0/5 (0%) | ||||
| Proctitis | 0/173 (0%) | 1/88 (1.1%) | 0/11 (0%) | 0/5 (0%) | ||||
| Rectal haemorrhage | 3/173 (1.7%) | 0/88 (0%) | 0/11 (0%) | 0/5 (0%) | ||||
| Retroperitoneal haematoma | 1/173 (0.6%) | 0/88 (0%) | 0/11 (0%) | 0/5 (0%) | ||||
| Vomiting | 1/173 (0.6%) | 0/88 (0%) | 0/11 (0%) | 0/5 (0%) | ||||
| Abdominal pain upper | 1/173 (0.6%) | 0/88 (0%) | 0/11 (0%) | 0/5 (0%) | ||||
| General disorders | ||||||||
| Death | 0/173 (0%) | 1/88 (1.1%) | 0/11 (0%) | 0/5 (0%) | ||||
| Multiple organ dysfunction syndrome | 0/173 (0%) | 0/88 (0%) | 0/11 (0%) | 1/5 (20%) | ||||
| Disease progression | 20/173 (11.6%) | 6/88 (6.8%) | 0/11 (0%) | 0/5 (0%) | ||||
| Asthenia | 2/173 (1.2%) | 0/88 (0%) | 0/11 (0%) | 0/5 (0%) | ||||
| Chest pain | 2/173 (1.2%) | 1/88 (1.1%) | 0/11 (0%) | 0/5 (0%) | ||||
| General physical health deterioration | 1/173 (0.6%) | 0/88 (0%) | 0/11 (0%) | 0/5 (0%) | ||||
| Impaired healing | 0/173 (0%) | 1/88 (1.1%) | 0/11 (0%) | 0/5 (0%) | ||||
| Mucosal inflammation | 1/173 (0.6%) | 0/88 (0%) | 0/11 (0%) | 0/5 (0%) | ||||
| Pyrexia | 1/173 (0.6%) | 0/88 (0%) | 1/11 (9.1%) | 0/5 (0%) | ||||
| Sudden death | 1/173 (0.6%) | 0/88 (0%) | 0/11 (0%) | 0/5 (0%) | ||||
| Hepatobiliary disorders | ||||||||
| Cholecystitis | 0/173 (0%) | 0/88 (0%) | 1/11 (9.1%) | 0/5 (0%) | ||||
| Cholecystitis acute | 1/173 (0.6%) | 0/88 (0%) | 0/11 (0%) | 0/5 (0%) | ||||
| Infections and infestations | ||||||||
| Cellulitis | 0/173 (0%) | 1/88 (1.1%) | 0/11 (0%) | 0/5 (0%) | ||||
| Gastroenteritis | 1/173 (0.6%) | 0/88 (0%) | 0/11 (0%) | 0/5 (0%) | ||||
| Upper respiratory tract infection | 0/173 (0%) | 0/88 (0%) | 1/11 (9.1%) | 0/5 (0%) | ||||
| Anal abscess | 0/173 (0%) | 0/88 (0%) | 0/11 (0%) | 1/5 (20%) | ||||
| Abscess | 1/173 (0.6%) | 0/88 (0%) | 0/11 (0%) | 0/5 (0%) | ||||
| Cholecystitis infective | 1/173 (0.6%) | 0/88 (0%) | 0/11 (0%) | 0/5 (0%) | ||||
| Pneumonia | 4/173 (2.3%) | 1/88 (1.1%) | 1/11 (9.1%) | 1/5 (20%) | ||||
| Pyelonephritis | 1/173 (0.6%) | 0/88 (0%) | 0/11 (0%) | 0/5 (0%) | ||||
| Sepsis | 2/173 (1.2%) | 0/88 (0%) | 0/11 (0%) | 0/5 (0%) | ||||
| Skin bacterial infection | 0/173 (0%) | 1/88 (1.1%) | 0/11 (0%) | 0/5 (0%) | ||||
| Tonsillitis | 1/173 (0.6%) | 0/88 (0%) | 0/11 (0%) | 0/5 (0%) | ||||
| Urinary tract infection | 2/173 (1.2%) | 0/88 (0%) | 0/11 (0%) | 0/5 (0%) | ||||
| Wound infection | 1/173 (0.6%) | 0/88 (0%) | 0/11 (0%) | 0/5 (0%) | ||||
| Injury, poisoning and procedural complications | ||||||||
| Ankle fracture | 0/173 (0%) | 1/88 (1.1%) | 0/11 (0%) | 0/5 (0%) | ||||
| Facial bones fracture | 0/173 (0%) | 1/88 (1.1%) | 0/11 (0%) | 0/5 (0%) | ||||
| Humerus fracture | 1/173 (0.6%) | 0/88 (0%) | 0/11 (0%) | 0/5 (0%) | ||||
| Multiple injuries | 0/173 (0%) | 1/88 (1.1%) | 0/11 (0%) | 0/5 (0%) | ||||
| Patella fracture | 0/173 (0%) | 1/88 (1.1%) | 0/11 (0%) | 0/5 (0%) | ||||
| Upper limb fracture | 0/173 (0%) | 1/88 (1.1%) | 1/11 (9.1%) | 0/5 (0%) | ||||
| Wound dehiscence | 2/173 (1.2%) | 0/88 (0%) | 0/11 (0%) | 0/5 (0%) | ||||
| Hip fracture | 1/173 (0.6%) | 0/88 (0%) | 0/11 (0%) | 0/5 (0%) | ||||
| Contusion | 1/173 (0.6%) | 0/88 (0%) | 0/11 (0%) | 0/5 (0%) | ||||
| Investigations | ||||||||
| Haemoglobin decreased | 0/173 (0%) | 0/88 (0%) | 1/11 (9.1%) | 0/5 (0%) | ||||
| Metabolism and nutrition disorders | ||||||||
| Decreased appetite | 1/173 (0.6%) | 0/88 (0%) | 0/11 (0%) | 0/5 (0%) | ||||
| Dehydration | 1/173 (0.6%) | 1/88 (1.1%) | 0/11 (0%) | 0/5 (0%) | ||||
| Hyperkalaemia | 0/173 (0%) | 2/88 (2.3%) | 0/11 (0%) | 0/5 (0%) | ||||
| Musculoskeletal and connective tissue disorders | ||||||||
| Back pain | 1/173 (0.6%) | 0/88 (0%) | 1/11 (9.1%) | 0/5 (0%) | ||||
| Muscular weakness | 1/173 (0.6%) | 0/88 (0%) | 0/11 (0%) | 0/5 (0%) | ||||
| Pathological fracture | 0/173 (0%) | 1/88 (1.1%) | 0/11 (0%) | 0/5 (0%) | ||||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||
| Cardiac neoplasm unspecified | 1/173 (0.6%) | 0/88 (0%) | 0/11 (0%) | 0/5 (0%) | ||||
| Renal cancer | 2/173 (1.2%) | 0/88 (0%) | 0/11 (0%) | 0/5 (0%) | ||||
| Renal cancer metastatic | 2/173 (1.2%) | 0/88 (0%) | 0/11 (0%) | 0/5 (0%) | ||||
| Renal cell carcinoma | 0/173 (0%) | 1/88 (1.1%) | 0/11 (0%) | 0/5 (0%) | ||||
| Tumour haemorrhage | 1/173 (0.6%) | 0/88 (0%) | 0/11 (0%) | 0/5 (0%) | ||||
| Malignant neoplasm progression | 3/173 (1.7%) | 0/88 (0%) | 0/11 (0%) | 0/5 (0%) | ||||
| Lung neoplasm malignant | 0/173 (0%) | 1/88 (1.1%) | 0/11 (0%) | 0/5 (0%) | ||||
| Nervous system disorders | ||||||||
| Axonal and demyelinating polyneuropathy | 0/173 (0%) | 1/88 (1.1%) | 0/11 (0%) | 1/5 (20%) | ||||
| Haemorrhagic stroke | 0/173 (0%) | 0/88 (0%) | 1/11 (9.1%) | 0/5 (0%) | ||||
| Cerebrovascular accident | 0/173 (0%) | 0/88 (0%) | 1/11 (9.1%) | 0/5 (0%) | ||||
| Ischaemic stroke | 1/173 (0.6%) | 0/88 (0%) | 0/11 (0%) | 0/5 (0%) | ||||
| Cerebral haemorrhage | 1/173 (0.6%) | 0/88 (0%) | 0/11 (0%) | 0/5 (0%) | ||||
| Cerebral ischaemia | 1/173 (0.6%) | 0/88 (0%) | 0/11 (0%) | 0/5 (0%) | ||||
| Paraparesis | 0/173 (0%) | 1/88 (1.1%) | 0/11 (0%) | 0/5 (0%) | ||||
| Spinal cord compression | 0/173 (0%) | 1/88 (1.1%) | 0/11 (0%) | 0/5 (0%) | ||||
| Syncope | 0/173 (0%) | 1/88 (1.1%) | 0/11 (0%) | 0/5 (0%) | ||||
| Renal and urinary disorders | ||||||||
| Ureteric obstruction | 0/173 (0%) | 0/88 (0%) | 1/11 (9.1%) | 0/5 (0%) | ||||
| Dysuria | 1/173 (0.6%) | 0/88 (0%) | 0/11 (0%) | 0/5 (0%) | ||||
| Haematuria | 1/173 (0.6%) | 0/88 (0%) | 0/11 (0%) | 0/5 (0%) | ||||
| Urinary retention | 0/173 (0%) | 1/88 (1.1%) | 0/11 (0%) | 0/5 (0%) | ||||
| Respiratory, thoracic and mediastinal disorders | ||||||||
| Cough | 1/173 (0.6%) | 0/88 (0%) | 0/11 (0%) | 0/5 (0%) | ||||
| Chronic obstructive pulmonary disease | 0/173 (0%) | 0/88 (0%) | 1/11 (9.1%) | 0/5 (0%) | ||||
| Epistaxis | 0/173 (0%) | 0/88 (0%) | 1/11 (9.1%) | 0/5 (0%) | ||||
| Pleural effusion | 2/173 (1.2%) | 3/88 (3.4%) | 0/11 (0%) | 0/5 (0%) | ||||
| Pulmonary embolism | 2/173 (1.2%) | 0/88 (0%) | 0/11 (0%) | 0/5 (0%) | ||||
| Atelectasis | 1/173 (0.6%) | 0/88 (0%) | 0/11 (0%) | 0/5 (0%) | ||||
| Dyspnoea | 1/173 (0.6%) | 0/88 (0%) | 0/11 (0%) | 0/5 (0%) | ||||
| Haemoptysis | 1/173 (0.6%) | 1/88 (1.1%) | 0/11 (0%) | 0/5 (0%) | ||||
| Pleurisy | 0/173 (0%) | 1/88 (1.1%) | 0/11 (0%) | 0/5 (0%) | ||||
| Pulmonary oedema | 1/173 (0.6%) | 0/88 (0%) | 0/11 (0%) | 0/5 (0%) | ||||
| Respiratory distress | 1/173 (0.6%) | 0/88 (0%) | 0/11 (0%) | 0/5 (0%) | ||||
| Respiratory failure | 0/173 (0%) | 1/88 (1.1%) | 0/11 (0%) | 0/5 (0%) | ||||
| Skin and subcutaneous tissue disorders | ||||||||
| Erythema multiforme | 0/173 (0%) | 1/88 (1.1%) | 0/11 (0%) | 0/5 (0%) | ||||
| Palmar-plantar erythrodysaesthesia syndrome | 0/173 (0%) | 2/88 (2.3%) | 0/11 (0%) | 0/5 (0%) | ||||
| Vascular disorders | ||||||||
| Angiopathy | 0/173 (0%) | 1/88 (1.1%) | 0/11 (0%) | 0/5 (0%) | ||||
| Hypertensive crisis | 1/173 (0.6%) | 0/88 (0%) | 0/11 (0%) | 0/5 (0%) | ||||
Other (Not Including Serious) Adverse Events |
||||||||
| Axitinib (First-line Participants) | Sorafenib (First-line Participants) | Axitinib (Second-line Participants) | Sorafenib (Second-line Participants) | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 161/173 (93.1%) | 83/88 (94.3%) | 11/11 (100%) | 5/5 (100%) | ||||
| Blood and lymphatic system disorders | ||||||||
| Anaemia | 15/173 (8.7%) | 9/88 (10.2%) | 2/11 (18.2%) | 2/5 (40%) | ||||
| Anisocytosis | 0/173 (0%) | 0/88 (0%) | 1/11 (9.1%) | 0/5 (0%) | ||||
| Macrocytosis | 0/173 (0%) | 0/88 (0%) | 1/11 (9.1%) | 0/5 (0%) | ||||
| Polychromasia | 0/173 (0%) | 0/88 (0%) | 1/11 (9.1%) | 0/5 (0%) | ||||
| Thrombocytopenia | 0/173 (0%) | 0/88 (0%) | 1/11 (9.1%) | 0/5 (0%) | ||||
| Thrombocytosis | 0/173 (0%) | 0/88 (0%) | 1/11 (9.1%) | 0/5 (0%) | ||||
| Ear and labyrinth disorders | ||||||||
| Tinnitus | 0/173 (0%) | 0/88 (0%) | 0/11 (0%) | 1/5 (20%) | ||||
| Endocrine disorders | ||||||||
| Hypothyroidism | 36/173 (20.8%) | 5/88 (5.7%) | 3/11 (27.3%) | 0/5 (0%) | ||||
| Hyperthyroidism | 0/173 (0%) | 0/88 (0%) | 2/11 (18.2%) | 0/5 (0%) | ||||
| Eye disorders | ||||||||
| Vision blurred | 0/173 (0%) | 0/88 (0%) | 0/11 (0%) | 1/5 (20%) | ||||
| Gastrointestinal disorders | ||||||||
| Abdominal pain | 17/173 (9.8%) | 8/88 (9.1%) | 3/11 (27.3%) | 0/5 (0%) | ||||
| Abdominal pain upper | 32/173 (18.5%) | 7/88 (8%) | 2/11 (18.2%) | 0/5 (0%) | ||||
| Constipation | 17/173 (9.8%) | 10/88 (11.4%) | 2/11 (18.2%) | 1/5 (20%) | ||||
| Diarrhoea | 88/173 (50.9%) | 34/88 (38.6%) | 6/11 (54.5%) | 2/5 (40%) | ||||
| Mouth ulceration | 0/173 (0%) | 0/88 (0%) | 1/11 (9.1%) | 0/5 (0%) | ||||
| Nausea | 38/173 (22%) | 15/88 (17%) | 1/11 (9.1%) | 0/5 (0%) | ||||
| Stomatitis | 20/173 (11.6%) | 4/88 (4.5%) | 2/11 (18.2%) | 1/5 (20%) | ||||
| Vomiting | 38/173 (22%) | 11/88 (12.5%) | 0/11 (0%) | 0/5 (0%) | ||||
| Abdominal distension | 9/173 (5.2%) | 1/88 (1.1%) | 1/11 (9.1%) | 0/5 (0%) | ||||
| Dry mouth | 10/173 (5.8%) | 1/88 (1.1%) | 0/11 (0%) | 0/5 (0%) | ||||
| Dyspepsia | 13/173 (7.5%) | 3/88 (3.4%) | 1/11 (9.1%) | 0/5 (0%) | ||||
| Flatulence | 10/173 (5.8%) | 3/88 (3.4%) | 0/11 (0%) | 0/5 (0%) | ||||
| Abdominal discomfort | 0/173 (0%) | 0/88 (0%) | 0/11 (0%) | 1/5 (20%) | ||||
| Anal fissure | 0/173 (0%) | 0/88 (0%) | 0/11 (0%) | 1/5 (20%) | ||||
| Cheilitis | 0/173 (0%) | 0/88 (0%) | 1/11 (9.1%) | 0/5 (0%) | ||||
| Duodenitis | 0/173 (0%) | 0/88 (0%) | 1/11 (9.1%) | 0/5 (0%) | ||||
| Gastric ulcer | 0/173 (0%) | 0/88 (0%) | 1/11 (9.1%) | 0/5 (0%) | ||||
| Gastrooesophageal reflux disease | 0/173 (0%) | 0/88 (0%) | 1/11 (9.1%) | 0/5 (0%) | ||||
| Gingival bleeding | 0/173 (0%) | 0/88 (0%) | 1/11 (9.1%) | 0/5 (0%) | ||||
| Glossodynia | 0/173 (0%) | 0/88 (0%) | 1/11 (9.1%) | 0/5 (0%) | ||||
| Haematemesis | 0/173 (0%) | 0/88 (0%) | 1/11 (9.1%) | 0/5 (0%) | ||||
| Haemorrhoids | 0/173 (0%) | 0/88 (0%) | 1/11 (9.1%) | 0/5 (0%) | ||||
| Hiatus hernia | 0/173 (0%) | 0/88 (0%) | 1/11 (9.1%) | 0/5 (0%) | ||||
| Hyperchlorhydria | 0/173 (0%) | 0/88 (0%) | 2/11 (18.2%) | 0/5 (0%) | ||||
| Melaena | 0/173 (0%) | 0/88 (0%) | 2/11 (18.2%) | 0/5 (0%) | ||||
| Oesophagitis | 0/173 (0%) | 0/88 (0%) | 1/11 (9.1%) | 0/5 (0%) | ||||
| Oral disorder | 0/173 (0%) | 0/88 (0%) | 1/11 (9.1%) | 0/5 (0%) | ||||
| Rectal haemorrhage | 0/173 (0%) | 0/88 (0%) | 1/11 (9.1%) | 0/5 (0%) | ||||
| Toothache | 0/173 (0%) | 0/88 (0%) | 2/11 (18.2%) | 0/5 (0%) | ||||
| Upper gastrointestinal haemorrhage | 0/173 (0%) | 0/88 (0%) | 0/11 (0%) | 1/5 (20%) | ||||
| General disorders | ||||||||
| Chest pain | 9/173 (5.2%) | 7/88 (8%) | 1/11 (9.1%) | 1/5 (20%) | ||||
| Fatigue | 55/173 (31.8%) | 25/88 (28.4%) | 4/11 (36.4%) | 2/5 (40%) | ||||
| Pyrexia | 9/173 (5.2%) | 4/88 (4.5%) | 2/11 (18.2%) | 0/5 (0%) | ||||
| Asthenia | 41/173 (23.7%) | 15/88 (17%) | 5/11 (45.5%) | 0/5 (0%) | ||||
| Mucosal inflammation | 21/173 (12.1%) | 9/88 (10.2%) | 1/11 (9.1%) | 0/5 (0%) | ||||
| Oedema peripheral | 10/173 (5.8%) | 4/88 (4.5%) | 1/11 (9.1%) | 0/5 (0%) | ||||
| Infections and infestations | ||||||||
| Nasopharyngitis | 10/173 (5.8%) | 3/88 (3.4%) | 2/11 (18.2%) | 0/5 (0%) | ||||
| Upper respiratory tract infection | 14/173 (8.1%) | 1/88 (1.1%) | 0/11 (0%) | 1/5 (20%) | ||||
| Urinary tract infection | 10/173 (5.8%) | 4/88 (4.5%) | 2/11 (18.2%) | 0/5 (0%) | ||||
| Haemorrhoid infection | 0/173 (0%) | 0/88 (0%) | 1/11 (9.1%) | 0/5 (0%) | ||||
| Pharyngotonsillitis | 0/173 (0%) | 0/88 (0%) | 1/11 (9.1%) | 0/5 (0%) | ||||
| Rhinitis | 0/173 (0%) | 0/88 (0%) | 1/11 (9.1%) | 0/5 (0%) | ||||
| Sinusitis | 0/173 (0%) | 0/88 (0%) | 1/11 (9.1%) | 0/5 (0%) | ||||
| Tonsillitis | 0/173 (0%) | 0/88 (0%) | 1/11 (9.1%) | 0/5 (0%) | ||||
| Tooth infection | 0/173 (0%) | 0/88 (0%) | 1/11 (9.1%) | 0/5 (0%) | ||||
| Injury, poisoning and procedural complications | ||||||||
| Fall | 10/173 (5.8%) | 0/88 (0%) | 1/11 (9.1%) | 0/5 (0%) | ||||
| Mucosal excoriation | 0/173 (0%) | 0/88 (0%) | 1/11 (9.1%) | 0/5 (0%) | ||||
| Skin abrasion | 0/173 (0%) | 0/88 (0%) | 1/11 (9.1%) | 0/5 (0%) | ||||
| Spinal compression fracture | 0/173 (0%) | 0/88 (0%) | 1/11 (9.1%) | 0/5 (0%) | ||||
| Investigations | ||||||||
| Alanine aminotransferase increased | 19/173 (11%) | 8/88 (9.1%) | 0/11 (0%) | 0/5 (0%) | ||||
| Aspartate aminotransferase increased | 17/173 (9.8%) | 8/88 (9.1%) | 0/11 (0%) | 0/5 (0%) | ||||
| Blood alkaline phosphatase increased | 7/173 (4%) | 6/88 (6.8%) | 0/11 (0%) | 0/5 (0%) | ||||
| Blood creatinine increased | 14/173 (8.1%) | 6/88 (6.8%) | 2/11 (18.2%) | 1/5 (20%) | ||||
| Blood phosphorus decreased | 0/173 (0%) | 0/88 (0%) | 1/11 (9.1%) | 1/5 (20%) | ||||
| Blood thyroid stimulating hormone increased | 17/173 (9.8%) | 2/88 (2.3%) | 1/11 (9.1%) | 0/5 (0%) | ||||
| Haemoglobin decreased | 0/173 (0%) | 0/88 (0%) | 2/11 (18.2%) | 0/5 (0%) | ||||
| Weight decreased | 70/173 (40.5%) | 24/88 (27.3%) | 4/11 (36.4%) | 1/5 (20%) | ||||
| Lipase increased | 7/173 (4%) | 5/88 (5.7%) | 2/11 (18.2%) | 1/5 (20%) | ||||
| Amylase increased | 0/173 (0%) | 0/88 (0%) | 3/11 (27.3%) | 1/5 (20%) | ||||
| Blood bicarbonate decreased | 0/173 (0%) | 0/88 (0%) | 1/11 (9.1%) | 1/5 (20%) | ||||
| Blood bilirubin increased | 0/173 (0%) | 0/88 (0%) | 1/11 (9.1%) | 0/5 (0%) | ||||
| Blood calcium increased | 0/173 (0%) | 0/88 (0%) | 1/11 (9.1%) | 0/5 (0%) | ||||
| Blood chloride increased | 0/173 (0%) | 0/88 (0%) | 1/11 (9.1%) | 0/5 (0%) | ||||
| Blood cholesterol increased | 0/173 (0%) | 0/88 (0%) | 0/11 (0%) | 1/5 (20%) | ||||
| Blood lactate dehydrogenase increased | 0/173 (0%) | 0/88 (0%) | 0/11 (0%) | 1/5 (20%) | ||||
| Blood urea increased | 0/173 (0%) | 0/88 (0%) | 0/11 (0%) | 1/5 (20%) | ||||
| Creatinine renal clearance decreased | 0/173 (0%) | 0/88 (0%) | 2/11 (18.2%) | 0/5 (0%) | ||||
| Eosinophil count increased | 0/173 (0%) | 0/88 (0%) | 1/11 (9.1%) | 0/5 (0%) | ||||
| Glomerular filtration rate decreased | 0/173 (0%) | 0/88 (0%) | 1/11 (9.1%) | 0/5 (0%) | ||||
| Haematocrit increased | 0/173 (0%) | 0/88 (0%) | 1/11 (9.1%) | 0/5 (0%) | ||||
| Haemoglobin increased | 0/173 (0%) | 0/88 (0%) | 1/11 (9.1%) | 0/5 (0%) | ||||
| International normalised ratio increased | 0/173 (0%) | 0/88 (0%) | 0/11 (0%) | 1/5 (20%) | ||||
| Liver function test increased | 0/173 (0%) | 0/88 (0%) | 1/11 (9.1%) | 2/5 (40%) | ||||
| Lymphocyte percentage decreased | 0/173 (0%) | 0/88 (0%) | 0/11 (0%) | 1/5 (20%) | ||||
| Protein total decreased | 0/173 (0%) | 0/88 (0%) | 1/11 (9.1%) | 0/5 (0%) | ||||
| Tri-iodothyronine free decreased | 0/173 (0%) | 0/88 (0%) | 1/11 (9.1%) | 0/5 (0%) | ||||
| Blood pressure increased | 0/173 (0%) | 0/88 (0%) | 2/11 (18.2%) | 0/5 (0%) | ||||
| Metabolism and nutrition disorders | ||||||||
| Decreased appetite | 48/173 (27.7%) | 16/88 (18.2%) | 5/11 (45.5%) | 0/5 (0%) | ||||
| Hyperkalaemia | 0/173 (0%) | 0/88 (0%) | 1/11 (9.1%) | 0/5 (0%) | ||||
| Hyperlipidaemia | 0/173 (0%) | 0/88 (0%) | 1/11 (9.1%) | 0/5 (0%) | ||||
| Hyperglycaemia | 6/173 (3.5%) | 5/88 (5.7%) | 0/11 (0%) | 0/5 (0%) | ||||
| Hyperuricaemia | 0/173 (0%) | 0/88 (0%) | 1/11 (9.1%) | 0/5 (0%) | ||||
| Musculoskeletal and connective tissue disorders | ||||||||
| Arthralgia | 28/173 (16.2%) | 10/88 (11.4%) | 5/11 (45.5%) | 1/5 (20%) | ||||
| Back pain | 29/173 (16.8%) | 14/88 (15.9%) | 6/11 (54.5%) | 0/5 (0%) | ||||
| Musculoskeletal pain | 0/173 (0%) | 0/88 (0%) | 0/11 (0%) | 1/5 (20%) | ||||
| Pain in extremity | 23/173 (13.3%) | 6/88 (6.8%) | 4/11 (36.4%) | 0/5 (0%) | ||||
| Muscle spasms | 3/173 (1.7%) | 6/88 (6.8%) | 0/11 (0%) | 0/5 (0%) | ||||
| Musculoskeletal chest pain | 7/173 (4%) | 5/88 (5.7%) | 0/11 (0%) | 0/5 (0%) | ||||
| Arthritis | 0/173 (0%) | 0/88 (0%) | 1/11 (9.1%) | 0/5 (0%) | ||||
| Flank pain | 0/173 (0%) | 0/88 (0%) | 1/11 (9.1%) | 0/5 (0%) | ||||
| Gouty arthritis | 0/173 (0%) | 0/88 (0%) | 1/11 (9.1%) | 0/5 (0%) | ||||
| Myalgia | 0/173 (0%) | 0/88 (0%) | 4/11 (36.4%) | 0/5 (0%) | ||||
| Osteoarthritis | 0/173 (0%) | 0/88 (0%) | 1/11 (9.1%) | 0/5 (0%) | ||||
| Periarthritis | 0/173 (0%) | 0/88 (0%) | 1/11 (9.1%) | 0/5 (0%) | ||||
| Joint swelling | 0/173 (0%) | 0/88 (0%) | 1/11 (9.1%) | 0/5 (0%) | ||||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||
| Anal neoplasm | 0/173 (0%) | 0/88 (0%) | 0/11 (0%) | 1/5 (20%) | ||||
| Nervous system disorders | ||||||||
| Dizziness | 14/173 (8.1%) | 2/88 (2.3%) | 1/11 (9.1%) | 0/5 (0%) | ||||
| Headache | 23/173 (13.3%) | 6/88 (6.8%) | 1/11 (9.1%) | 0/5 (0%) | ||||
| Dizziness exertional | 0/173 (0%) | 0/88 (0%) | 1/11 (9.1%) | 0/5 (0%) | ||||
| Dysaesthesia | 0/173 (0%) | 0/88 (0%) | 1/11 (9.1%) | 0/5 (0%) | ||||
| Neuralgia | 0/173 (0%) | 0/88 (0%) | 0/11 (0%) | 1/5 (20%) | ||||
| Psychiatric disorders | ||||||||
| Anxiety | 10/173 (5.8%) | 0/88 (0%) | 0/11 (0%) | 0/5 (0%) | ||||
| Insomnia | 10/173 (5.8%) | 5/88 (5.7%) | 1/11 (9.1%) | 0/5 (0%) | ||||
| Renal and urinary disorders | ||||||||
| Proteinuria | 19/173 (11%) | 9/88 (10.2%) | 6/11 (54.5%) | 0/5 (0%) | ||||
| Chronic kidney disease | 0/173 (0%) | 0/88 (0%) | 0/11 (0%) | 1/5 (20%) | ||||
| Dysuria | 0/173 (0%) | 0/88 (0%) | 1/11 (9.1%) | 0/5 (0%) | ||||
| Haematuria | 0/173 (0%) | 0/88 (0%) | 1/11 (9.1%) | 0/5 (0%) | ||||
| Pollakiuria | 0/173 (0%) | 0/88 (0%) | 1/11 (9.1%) | 0/5 (0%) | ||||
| Reproductive system and breast disorders | ||||||||
| Breast mass | 0/173 (0%) | 0/88 (0%) | 0/11 (0%) | 1/5 (20%) | ||||
| Respiratory, thoracic and mediastinal disorders | ||||||||
| Cough | 33/173 (19.1%) | 14/88 (15.9%) | 2/11 (18.2%) | 1/5 (20%) | ||||
| Dysphonia | 37/173 (21.4%) | 10/88 (11.4%) | 0/11 (0%) | 0/5 (0%) | ||||
| Dyspnoea | 24/173 (13.9%) | 11/88 (12.5%) | 0/11 (0%) | 0/5 (0%) | ||||
| Pleural effusion | 3/173 (1.7%) | 5/88 (5.7%) | 0/11 (0%) | 0/5 (0%) | ||||
| Epistaxis | 7/173 (4%) | 5/88 (5.7%) | 0/11 (0%) | 0/5 (0%) | ||||
| Oropharyngeal pain | 12/173 (6.9%) | 5/88 (5.7%) | 4/11 (36.4%) | 0/5 (0%) | ||||
| Dry throat | 0/173 (0%) | 0/88 (0%) | 1/11 (9.1%) | 0/5 (0%) | ||||
| Skin and subcutaneous tissue disorders | ||||||||
| Alopecia | 6/173 (3.5%) | 17/88 (19.3%) | 1/11 (9.1%) | 1/5 (20%) | ||||
| Palmar-plantar erythrodysaesthesia syndrome | 41/173 (23.7%) | 31/88 (35.2%) | 4/11 (36.4%) | 4/5 (80%) | ||||
| Rash | 15/173 (8.7%) | 18/88 (20.5%) | 1/11 (9.1%) | 0/5 (0%) | ||||
| Erythema | 5/173 (2.9%) | 21/88 (23.9%) | 0/11 (0%) | 0/5 (0%) | ||||
| Pruritus | 7/173 (4%) | 9/88 (10.2%) | 1/11 (9.1%) | 1/5 (20%) | ||||
| Skin exfoliation | 3/173 (1.7%) | 6/88 (6.8%) | 1/11 (9.1%) | 0/5 (0%) | ||||
| Blister | 0/173 (0%) | 0/88 (0%) | 1/11 (9.1%) | 0/5 (0%) | ||||
| Dry skin | 0/173 (0%) | 0/88 (0%) | 1/11 (9.1%) | 0/5 (0%) | ||||
| Eczema | 0/173 (0%) | 0/88 (0%) | 1/11 (9.1%) | 0/5 (0%) | ||||
| Pain of skin | 0/173 (0%) | 0/88 (0%) | 1/11 (9.1%) | 0/5 (0%) | ||||
| Pigmentation disorder | 0/173 (0%) | 0/88 (0%) | 1/11 (9.1%) | 0/5 (0%) | ||||
| Rash erythematous | 0/173 (0%) | 0/88 (0%) | 1/11 (9.1%) | 0/5 (0%) | ||||
| Skin fissures | 0/173 (0%) | 0/88 (0%) | 1/11 (9.1%) | 0/5 (0%) | ||||
| Skin hyperpigmentation | 0/173 (0%) | 0/88 (0%) | 1/11 (9.1%) | 0/5 (0%) | ||||
| Skin lesion | 0/173 (0%) | 0/88 (0%) | 2/11 (18.2%) | 0/5 (0%) | ||||
| Skin mass | 0/173 (0%) | 0/88 (0%) | 0/11 (0%) | 1/5 (20%) | ||||
| Skin toxicity | 0/173 (0%) | 0/88 (0%) | 1/11 (9.1%) | 0/5 (0%) | ||||
| Skin ulcer | 0/173 (0%) | 0/88 (0%) | 1/11 (9.1%) | 0/5 (0%) | ||||
| Surgical and medical procedures | ||||||||
| Haemostasis | 0/173 (0%) | 0/88 (0%) | 1/11 (9.1%) | 0/5 (0%) | ||||
| Vascular disorders | ||||||||
| Hypertension | 83/173 (48%) | 28/88 (31.8%) | 4/11 (36.4%) | 1/5 (20%) | ||||
| Hypotension | 13/173 (7.5%) | 3/88 (3.4%) | 0/11 (0%) | 0/5 (0%) | ||||
Limitations/Caveats
The objective of the statistical analysis for secondary endpoints was to summarize data using descriptive statistics without performing any hypothesis testing. Safety analysis did not include data from all China participants due to inability to obtain timely approval to use data in accordance to HGRAC regulations.
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
| Name/Title | Pfizer ClinicalTrials.gov Call Center |
|---|---|
| Organization | Pfizer Inc. |
| Phone | 1-800-718-1021 |
| ClinicalTrials.gov_Inquiries@pfizer.com |
Responsible Party:
Pfizer
ClinicalTrials.gov Identifier:
NCT00920816
Other Study ID Numbers:
- A4061051
- 2010-018585-23
First Posted:
Jun 15, 2009
Last Update Posted:
May 6, 2022
Last Verified:
Apr 1, 2022