Pazopanib Versus Sunitinib in the Treatment of Asian Subjects With Locally Advanced and/or Metastatic Renal Cell Carcinoma

Sponsor
Novartis Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT01147822
Collaborator
(none)
183
21
2
135.5
8.7
0.1

Study Details

Study Description

Brief Summary

This study is being conducted to provide a direct comparison of the efficacy, safety, and tolerabilityfor pazopanib and sunitinib (SUTENT) in the Asian population.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

The study is designed to evaluate efficacy and safety of pazopanib versus sunitinib for the treatment of Asian subjects with locally advanced and/or metastatic renal cell carcinoma (RCC) enrolled from selected Far-East Asian countries. The primary objective is to evaluate the primary endpoint progression free survival in the enrolled Asian subjects treated with pazopanib versus those treated with sunitinib. The secondary objectives are to evaluate the following secondary endpoints in each treatment arm: objective response rate, duration of response, time to response, overall survival and safety. Subjects will be randomized in a 1:1 ratio to receive either 800mg pazopanib to be administered once daily orally continuous dosing or 50mg sunitinib to be administered in 6-week cycles: 50mg orally daily for 4 weeks followed by 2 weeks off treatment. Subjects are permitted to receive supportive care throughout the study including transfusion of blood and blood products, treatment with antibiotics, anti-emetics, anti-diarrheal agents, analgesics, erythropoietin, or bisphosphonates, when appropriate. The study treatment will continue until subjects experience disease progression, unacceptable toxicity, withdraw consent, or death.

Study Design

Study Type:
Interventional
Actual Enrollment :
183 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Study to Evaluate Efficacy and Safety of Pazopanib Versus Sunitinib for the Treatment of Asian Subjects With Locally Advanced and/or Metastatic Renal Cell Carcinoma - A Substudy to VEG108844
Actual Study Start Date :
May 19, 2010
Actual Primary Completion Date :
May 21, 2012
Actual Study Completion Date :
Sep 3, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Pazopanib

800 mg administered once daily orally continuous dosing

Drug: Pazopanib
800 mg administered once daily orally continuous dosing

Active Comparator: Sunitinib

50 mg sunitinib to be administered in 6-week cycles: 50 mg orally daily for 4 weeks followed by 2 weeks off treatment

Drug: Sunitinib
50 mg sunitinib to be administered in 6-week cycle: 50 mg orally daily for 4 weeks followed by 2 weeks off treatment

Outcome Measures

Primary Outcome Measures

  1. Progression-free Survival (PFS) [From randomization to the earliest date of disease progression or death (up to 39 months)]

    PFS is defined as the interval between the date of randomization and the earliest date of progressive disease (PD), as defined by the Independent Review Committee (IRC), or death due to any cause. The IRC defined PD per Response Evaluation Criteria in Solid Tumors (RECIST), Version 1. Per RECIST, PD is defined as a >=20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter (LD) recorded since the treatment started or the appearance of >=1 new lesion. Participants who had neither progressed nor died were censored at the date of the last adequate tumor assessment at the time of the cut-off.

Secondary Outcome Measures

  1. Overall Survival (OS) [From randomization until death (up to 44 months)]

    OS is defined as the time from randomization until death due to any cause. Participants who had not died were censored at the date of the last adequate tumor assessment at the time of the cut-off.

  2. Number of Participants With a Best Response of Confirmed Complete Response (CR) or Confirmed Partial Response (PR) as Assessed by the IRC [From Baseline until the time of response or the earliest date of disease progression/death (up to 39 months)]

    The number of participants with evidence of CR (the disappearance of all target lesions. Any pathological lymph node must be less than 10 millimeters [mm] in the short axis) or PR (at least a 30% decrease in the sum of the longest diameters [LD] of target lesions, taking as a reference the Baseline sum LD) was evaluated by an independent review per RECIST, Version 1.

  3. Time to Response [From Baseline until the time of response or the earliest date of disease progression/death (up to 39 months)]

    Time to response is defined as the time from the start of treatment until the first documented evidence of confirmed CR (the disappearance of all target lesions. Any pathological lymph node must be less than 10 mm in the short axis) or PR (at least a 30% decrease in the sum of the LD of target lesions, taking as a reference the Baseline sum LD), whichever comes first. CR and PR were evaluated by an independent review per RECIST, Version 1.

  4. Duration of Response (DOR) [From the time of response until the earliest date of disease progression/death (up to 38 months)]

    DOR is defined as the time from the first documented evidence of confirmed response (CR or PR) until the first documented sign of disease progression (a >=20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of >=1 new lesion) or death, if sooner. CR=the disappearance of all target lesions. Any pathological lymph node must be less than 10 mm in the short axis. PR=at least a 30% decrease in the sum of the LD of target lesions, taking as a reference the Baseline sum LD.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Written informed consent

  • Diagnosis of renal cell carcinoma with clear-cell component histology.

  • Received no prior systemic therapy (interleukin-2, interferon-alpha, chemotherapy, bevacizumab, mTOR inhibitor, sunitinib, sorafenib or other VEGF TKI) for advanced or metastatic RCC

  • Locally advanced or metastatic renal cell carcinoma Measurable disease by CT or MRI

  • Karnofsky performance scale status of >=70

  • Age >=18 years

  • A female is eligible to enter and participate in this study if she is of: non-childbearing or agrees to use adequate contraception.

  • Adequate organ system function

  • Total serum calcium concentration <12.0mg/dL

  • Left ventricular ejection fraction >= lower limit of institutional normal

Exclusion Criteria:
  • Pregnant or lactating female (unless agrees to refrain from nursing throughout the treatment period and for 14 days following the last dose of study)-History of another malignancy (unless have been disease-free for 3 years)

  • History or clinical evidence of central nervous system (CNS) metastases (unless have previously-treated CNS metastases and meet all 3 of the following criteria are: are asymptomatic, have had no evidence of active CNS metastases for >=6 months prior to enrolment, and have no requirement for steroids or enzyme-inducing anticonvulsants)

  • Clinically significant gastrointestinal abnormalities including, but not limited to: malabsorption syndrome, major resection of the stomach or small bowel that could affect the absorption of study drug, active peptic ulcer disease, known intraluminal metastatic lesion/s with suspected bleeding, Inflammatory bowel disease, ulcerative colitis, or other gastrointestinal conditions with increased risk of perforation, history of abdominal fistula, gastrointestinal perforation, or intra abdominal abscess within 28 days prior to beginning study treatment

  • Presence of uncontrolled infection

  • Prolongation of corrected QT interval (QTc) > 480 milliseconds

  • History of any one or more of the following cardiovascular conditions within the past 12 months: cardiac angioplasty or stenting, myocardial infarction, unstable angina, coronary artery by-pass graft surgery, symptomatic peripheral vascular disease, Class III or IV congestive heart failure, as defined by the New York Heart Association

  • History of cerebrovascular accident including transient ischemic attack within the past 12 months

  • History of pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months (unless had recent DVT and have been treated with therapeutic anti-coagulating agents for at least 6 weeks)

  • Poorly controlled hypertension (defined as systolic blood pressure of >=150mmHg or diastolic blood pressure of >=90mmHg). Initiation or adjustment of antihypertensive medication(s) is permitted prior to study entry

  • Prior major surgery or trauma within 28 days prior to first dose of study drug and/or presence of any non-healing wound, fracture, or ulcer.

  • Evidence of active bleeding or bleeding susceptibility

  • Spitting/coughing up blood within 6 weeks of first dose of study drug

  • Known endobronchial lesions and/or lesions infiltrating major pulmonary vessels

  • Any serious and/or unstable pre-existing medical, psychiatric, or other conditions that could interfere with patient's safety, obtaining informed consent or compliance to the study

  • Use any prohibited medications within 14 days of the first dose of study medication

  • Use of an investigational agent, including an investigational anti-cancer agent, within 28 days or 5 half-lives, whichever is longer, prior to the first dose of study drug

  • Prior use of an investigational or licensed drug that targets VEGF or VEGF receptors (eg. bevacizumab, sunitinib, sorafenib, etc), or are mTOR inhibitors (eg. temsirolimus, everolimus, etc).

  • Is now undergoing and/or has undergone in the 14 days immediately prior to first dose of study drug, any cancer therapy (surgery, tumor embolization, chemotherapy, radiation therapy, immunotherapy, biological therapy, or hormonal therapy)

  • Any ongoing toxicity from prior anti-cancer therapy that is >Grade 1 and/or that is progressing in severity

  • Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to pazopanib or sunitinib

Contacts and Locations

Locations

Site City State Country Postal Code
1 Novartis Investigative Site Guangzhou Guangdong China 510060
2 Novartis Investigative Site Nanjing Jiangsu China 210002
3 Novartis Investigative Site Hangzhou Zhejiang China 310003
4 Novartis Investigative Site Beijing China 100021
5 Novartis Investigative Site Beijing China 100036
6 Novartis Investigative Site Beijing China 100853
7 Novartis Investigative Site Beijing China
8 Novartis Investigative Site Shanghai China 200032
9 Novartis Investigative Site Shanghai China 200127
10 Novartis Investigative Site Tianjin China 300060
11 Novartis Investigative Site Daejeon Korea, Republic of 301-721
12 Novartis Investigative Site Goyang-si, Gyeonggi-Do Korea, Republic of 410-769
13 Novartis Investigative Site Seoul Korea, Republic of 120-752
14 Novartis Investigative Site Seoul Korea, Republic of 135-710
15 Novartis Investigative Site Seoul Korea, Republic of 138-736
16 Novartis Investigative Site Kaohsiung Hsien Taiwan 833
17 Novartis Investigative Site Taichung Taiwan 40402
18 Novartis Investigative Site Taichung Taiwan 40705
19 Novartis Investigative Site Taipei Taiwan 10002
20 Novartis Investigative Site Taipei Taiwan 11217
21 Novartis Investigative Site Taoyuan County Taiwan 333

Sponsors and Collaborators

  • Novartis Pharmaceuticals

Investigators

  • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01147822
Other Study ID Numbers:
  • 113078
  • CPZP034A2201
First Posted:
Jun 22, 2010
Last Update Posted:
Dec 14, 2021
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Keywords provided by Novartis Pharmaceuticals
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details Study VEG113078 is a substudy of Study VEG108844 (NCT00720941). Due to the projected limited enrollment of Asian participants into Study VEG108844, Study VEG113078 was designed to evaluate the efficacy and safety of pazopanib versus sunitinib for the treatment of Asian participants (par.) enrolled from selected Far-East Asian countries.
Pre-assignment Detail Par. from China, Korea, and Taiwan who enrolled in either Study VEG108844 or VEG113078 and par. from Japan who enrolled in Study VEG108844 were pooled for analysis of the Asian population, presented in this report. Only 183 participants were enrolled in Study VEG113078 (as reflected in the Enrollment field in the Protocol record).
Arm/Group Title Pazopanib 800 mg Sunitinib 50 mg
Arm/Group Description Participants were administered pazopanib 800 milligrams (mg) (2 x 400 mg tablets) orally once daily (OD) continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Study treatment continued until participants experienced disease progression, death, or unacceptable toxicity, or withdrew consent for any other reason. Participants were administered sunitinib 50 mg capsules orally OD in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Study treatment continued until participants experienced disease progression, death, or unacceptable toxicity, or withdrew consent for any other reason.
Period Title: Overall Study
STARTED 188 179
Not Completed/Ongoing 111 102
COMPLETED 0 0
NOT COMPLETED 188 179

Baseline Characteristics

Arm/Group Title Pazopanib 800 mg Sunitinib 50 mg Total
Arm/Group Description Participants were administered pazopanib 800 milligrams (mg) (2 x 400 mg tablets) orally once daily (OD) continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Study treatment continued until participants experienced disease progression, death, or unacceptable toxicity, or withdrew consent for any other reason. Participants were administered sunitinib 50 mg capsules orally OD in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Study treatment continued until participants experienced disease progression, death, or unacceptable toxicity, or withdrew consent for any other reason. Total of all reporting groups
Overall Participants 188 179 367
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]
57.7
(11.51)
57.6
(11.19)
57.6
(11.34)
Sex: Female, Male (Count of Participants)
Female
51
27.1%
42
23.5%
93
25.3%
Male
137
72.9%
137
76.5%
274
74.7%
Race/Ethnicity, Customized (Number) [Number]
Asian - Central/South Asian Heritage
2
1.1%
1
0.6%
3
0.8%
Asian - East Asian Heritage
154
81.9%
144
80.4%
298
81.2%
Asian - Japanese Heritage
29
15.4%
31
17.3%
60
16.3%
Asian - South East Asian Heritage
3
1.6%
3
1.7%
6
1.6%

Outcome Measures

1. Primary Outcome
Title Progression-free Survival (PFS)
Description PFS is defined as the interval between the date of randomization and the earliest date of progressive disease (PD), as defined by the Independent Review Committee (IRC), or death due to any cause. The IRC defined PD per Response Evaluation Criteria in Solid Tumors (RECIST), Version 1. Per RECIST, PD is defined as a >=20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter (LD) recorded since the treatment started or the appearance of >=1 new lesion. Participants who had neither progressed nor died were censored at the date of the last adequate tumor assessment at the time of the cut-off.
Time Frame From randomization to the earliest date of disease progression or death (up to 39 months)

Outcome Measure Data

Analysis Population Description
Intent-to-Treat (ITT) Population (Asian): All randomized participants (par) from Study VEG113078 and Study VEG108844 who enrolled in Japan, China, Taiwan, and Korea.
Arm/Group Title Pazopanib 800 mg Sunitinib 50 mg
Arm/Group Description Participants were administered pazopanib 800 milligrams (mg) (2 x 400 mg tablets) orally once daily (OD) continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Study treatment continued until participants experienced disease progression, death, or unacceptable toxicity, or withdrew consent for any other reason. Participants were administered sunitinib 50 mg capsules orally OD in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Study treatment continued until participants experienced disease progression, death, or unacceptable toxicity, or withdrew consent for any other reason.
Measure Participants 188 179
Median (95% Confidence Interval) [Months]
8.4
11.1
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pazopanib 800 mg, Sunitinib 50 mg
Comments
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 1.0184
Confidence Interval (2-Sided) 95%
0.7658 to 1.3542
Parameter Dispersion Type:
Value:
Estimation Comments The HR was estimated by the Cox regression model using treatment stratification factors as covariates. The HR was adjusted for Karnofsky Performance Scale scores, prior nephrectomy, and Baseline levels of lactate dehydrogenase.
2. Secondary Outcome
Title Overall Survival (OS)
Description OS is defined as the time from randomization until death due to any cause. Participants who had not died were censored at the date of the last adequate tumor assessment at the time of the cut-off.
Time Frame From randomization until death (up to 44 months)

Outcome Measure Data

Analysis Population Description
ITT Population (Asian)
Arm/Group Title Pazopanib 800 mg Sunitinib 50 mg
Arm/Group Description Participants were administered pazopanib 800 milligrams (mg) (2 x 400 mg tablets) orally once daily (OD) continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Study treatment continued until participants experienced disease progression, death, or unacceptable toxicity, or withdrew consent for any other reason. Participants were administered sunitinib 50 mg capsules orally OD in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Study treatment continued until participants experienced disease progression, death, or unacceptable toxicity, or withdrew consent for any other reason.
Measure Participants 188 179
Median (95% Confidence Interval) [Months]
NA
31.5
3. Secondary Outcome
Title Number of Participants With a Best Response of Confirmed Complete Response (CR) or Confirmed Partial Response (PR) as Assessed by the IRC
Description The number of participants with evidence of CR (the disappearance of all target lesions. Any pathological lymph node must be less than 10 millimeters [mm] in the short axis) or PR (at least a 30% decrease in the sum of the longest diameters [LD] of target lesions, taking as a reference the Baseline sum LD) was evaluated by an independent review per RECIST, Version 1.
Time Frame From Baseline until the time of response or the earliest date of disease progression/death (up to 39 months)

Outcome Measure Data

Analysis Population Description
ITT Population (Asian)
Arm/Group Title Pazopanib 800 mg Sunitinib 50 mg
Arm/Group Description Participants were administered pazopanib 800 milligrams (mg) (2 x 400 mg tablets) orally once daily (OD) continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Study treatment continued until participants experienced disease progression, death, or unacceptable toxicity, or withdrew consent for any other reason. Participants were administered sunitinib 50 mg capsules orally OD in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Study treatment continued until participants experienced disease progression, death, or unacceptable toxicity, or withdrew consent for any other reason.
Measure Participants 188 179
Complete Response
1
0.5%
0
0%
Partial Response
66
35.1%
37
20.7%
4. Secondary Outcome
Title Time to Response
Description Time to response is defined as the time from the start of treatment until the first documented evidence of confirmed CR (the disappearance of all target lesions. Any pathological lymph node must be less than 10 mm in the short axis) or PR (at least a 30% decrease in the sum of the LD of target lesions, taking as a reference the Baseline sum LD), whichever comes first. CR and PR were evaluated by an independent review per RECIST, Version 1.
Time Frame From Baseline until the time of response or the earliest date of disease progression/death (up to 39 months)

Outcome Measure Data

Analysis Population Description
ITT Population (Asian). Only those participants who experienced either a confirmed CR or a PR were analyzed.
Arm/Group Title Pazopanib 800 mg Sunitinib 50 mg
Arm/Group Description Participants were administered pazopanib 800 milligrams (mg) (2 x 400 mg tablets) orally once daily (OD) continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Study treatment continued until participants experienced disease progression, death, or unacceptable toxicity, or withdrew consent for any other reason. Participants were administered sunitinib 50 mg capsules orally OD in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Study treatment continued until participants experienced disease progression, death, or unacceptable toxicity, or withdrew consent for any other reason.
Measure Participants 67 37
Median (95% Confidence Interval) [Weeks]
11.9
17.9
5. Secondary Outcome
Title Duration of Response (DOR)
Description DOR is defined as the time from the first documented evidence of confirmed response (CR or PR) until the first documented sign of disease progression (a >=20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of >=1 new lesion) or death, if sooner. CR=the disappearance of all target lesions. Any pathological lymph node must be less than 10 mm in the short axis. PR=at least a 30% decrease in the sum of the LD of target lesions, taking as a reference the Baseline sum LD.
Time Frame From the time of response until the earliest date of disease progression/death (up to 38 months)

Outcome Measure Data

Analysis Population Description
ITT Population (Asian). Only those participants who experienced either a confirmed CR or a PR were analyzed.
Arm/Group Title Pazopanib 800 mg Sunitinib 50 mg
Arm/Group Description Participants were administered pazopanib 800 milligrams (mg) (2 x 400 mg tablets) orally once daily (OD) continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Study treatment continued until participants experienced disease progression, death, or unacceptable toxicity, or withdrew consent for any other reason. Participants were administered sunitinib 50 mg capsules orally OD in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Study treatment continued until participants experienced disease progression, death, or unacceptable toxicity, or withdrew consent for any other reason.
Measure Participants 67 37
Median (95% Confidence Interval) [Months]
15.2
18.0

Adverse Events

Time Frame Participants were analyzed from the first dose of study medication until the follow-up contact (up to Study Week 156).
Adverse Event Reporting Description Serious adverse events (SAEs) and non-serious AEs were collected in the Safety Population, comprised of all randomized participants who received at least one dose of study medication, according to the actual treatment received.
Arm/Group Title Pazopanib 800 mg Sunitinib 50 mg
Arm/Group Description Participants were administered pazopanib 800 milligrams (mg) (2 x 400 mg tablets) orally once daily (OD) continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Study treatment continued until participants experienced disease progression, death, or unacceptable toxicity, or withdrew consent for any other reason. Participants were administered sunitinib 50 mg capsules orally OD in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Study treatment continued until participants experienced disease progression, death, or unacceptable toxicity, or withdrew consent for any other reason.
All Cause Mortality
Pazopanib 800 mg Sunitinib 50 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total / (NaN) / (NaN)
Serious Adverse Events
Pazopanib 800 mg Sunitinib 50 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 68/186 (36.6%) 73/177 (41.2%)
Blood and lymphatic system disorders
Anemia 4/186 (2.2%) 4/177 (2.3%)
Febrile neutropenia 2/186 (1.1%) 0/177 (0%)
Thrombocytopenia 2/186 (1.1%) 15/177 (8.5%)
Neutropenia 1/186 (0.5%) 5/177 (2.8%)
Lymphopenia 0/186 (0%) 1/177 (0.6%)
Cardiac disorders
Cardiac failure congestive 1/186 (0.5%) 0/177 (0%)
Cardiopulmonary failure 1/186 (0.5%) 0/177 (0%)
Angina unstable 0/186 (0%) 1/177 (0.6%)
Ear and labyrinth disorders
Sudden hearing loss 0/186 (0%) 1/177 (0.6%)
Gastrointestinal disorders
Diarrhea 2/186 (1.1%) 1/177 (0.6%)
Ileus 2/186 (1.1%) 0/177 (0%)
Anal fistula 1/186 (0.5%) 0/177 (0%)
Ascites 1/186 (0.5%) 0/177 (0%)
Colonic polyp 1/186 (0.5%) 0/177 (0%)
Duodenal ulcer 1/186 (0.5%) 0/177 (0%)
Enterocolitis 1/186 (0.5%) 0/177 (0%)
Gastritis erosive 1/186 (0.5%) 0/177 (0%)
Lower gastrointestinal hemorrhage 1/186 (0.5%) 0/177 (0%)
Nausea 1/186 (0.5%) 0/177 (0%)
Small intestinal hemorrhage 1/186 (0.5%) 0/177 (0%)
Upper gastrointestinal hemorrhage 1/186 (0.5%) 2/177 (1.1%)
Vomiting 1/186 (0.5%) 0/177 (0%)
Abdominal distension 0/186 (0%) 1/177 (0.6%)
Gastritis 0/186 (0%) 1/177 (0.6%)
Gastrointestinal hemorrhage 0/186 (0%) 1/177 (0.6%)
Pancreatitis acute 0/186 (0%) 1/177 (0.6%)
General disorders
Pyrexia 3/186 (1.6%) 7/177 (4%)
Disease progression 1/186 (0.5%) 0/177 (0%)
Fatigue 1/186 (0.5%) 4/177 (2.3%)
Pain 1/186 (0.5%) 0/177 (0%)
Asthenia 0/186 (0%) 2/177 (1.1%)
Hepatobiliary disorders
Hepatic function abnormal 6/186 (3.2%) 3/177 (1.7%)
Cholecystitis acute 1/186 (0.5%) 0/177 (0%)
Drug-induced liver injury 1/186 (0.5%) 1/177 (0.6%)
Cholecystitis 0/186 (0%) 1/177 (0.6%)
Hepatitis 0/186 (0%) 1/177 (0.6%)
Hyperbilirubinemia 0/186 (0%) 2/177 (1.1%)
Infections and infestations
Pneumonia 2/186 (1.1%) 1/177 (0.6%)
Appendicitis 1/186 (0.5%) 1/177 (0.6%)
Cellulitis 1/186 (0.5%) 0/177 (0%)
H1N1 influenza 1/186 (0.5%) 0/177 (0%)
Infection 1/186 (0.5%) 0/177 (0%)
Lung infection 1/186 (0.5%) 0/177 (0%)
Septic shock 1/186 (0.5%) 0/177 (0%)
Gastroenteritis 0/186 (0%) 1/177 (0.6%)
Herpes zoster 0/186 (0%) 1/177 (0.6%)
Perinephric abscess 0/186 (0%) 1/177 (0.6%)
Peritonitis 0/186 (0%) 1/177 (0.6%)
Pneumonia bacterial 0/186 (0%) 1/177 (0.6%)
Retroperitoneal abscess 0/186 (0%) 1/177 (0.6%)
Injury, poisoning and procedural complications
Brain herniation 1/186 (0.5%) 0/177 (0%)
Contusion 1/186 (0.5%) 0/177 (0%)
Fracture 0/186 (0%) 1/177 (0.6%)
Patella fracture 0/186 (0%) 1/177 (0.6%)
Investigations
Alanine aminotransferase increased 11/186 (5.9%) 3/177 (1.7%)
Aspartate aminotransferase increased 4/186 (2.2%) 0/177 (0%)
Lipase increased 4/186 (2.2%) 3/177 (1.7%)
Neutrophil count decreased 2/186 (1.1%) 0/177 (0%)
Blood bilirubin increased 1/186 (0.5%) 1/177 (0.6%)
Blood glucose decreased 1/186 (0.5%) 0/177 (0%)
Blood potassium increased 1/186 (0.5%) 0/177 (0%)
Gamma-glutamyltransferase increased 1/186 (0.5%) 0/177 (0%)
Liver function test abnormal 1/186 (0.5%) 0/177 (0%)
Amylase increased 0/186 (0%) 1/177 (0.6%)
Blood calcium increased 0/186 (0%) 1/177 (0.6%)
Blood creatine phosphokinase increased 0/186 (0%) 1/177 (0.6%)
Blood magnesium decreased 0/186 (0%) 1/177 (0.6%)
Platelet count decreased 0/186 (0%) 7/177 (4%)
Metabolism and nutrition disorders
Hyponatremia 3/186 (1.6%) 2/177 (1.1%)
Decreased appetite 2/186 (1.1%) 0/177 (0%)
Hypercalcemia 1/186 (0.5%) 0/177 (0%)
Hyperlipasemia 1/186 (0.5%) 0/177 (0%)
Hyperuricemia 1/186 (0.5%) 2/177 (1.1%)
Hypocalcemia 1/186 (0.5%) 0/177 (0%)
Hyperkalemia 0/186 (0%) 1/177 (0.6%)
Musculoskeletal and connective tissue disorders
Arthralgia 1/186 (0.5%) 0/177 (0%)
Back pain 1/186 (0.5%) 2/177 (1.1%)
Bone pain 1/186 (0.5%) 0/177 (0%)
Flank pain 1/186 (0.5%) 1/177 (0.6%)
Pain in extremity 1/186 (0.5%) 1/177 (0.6%)
Fistula 0/186 (0%) 1/177 (0.6%)
Musculoskeletal pain 0/186 (0%) 1/177 (0.6%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer 2/186 (1.1%) 0/177 (0%)
Cancer pain 1/186 (0.5%) 0/177 (0%)
Metastases to central nervous system 1/186 (0.5%) 0/177 (0%)
Tumour rupture 1/186 (0.5%) 0/177 (0%)
Gastric cancer 0/186 (0%) 1/177 (0.6%)
Tumour hemorrhage 0/186 (0%) 1/177 (0.6%)
Nervous system disorders
Cerebral hemorrhage 1/186 (0.5%) 0/177 (0%)
Hemorrhage intracranial 1/186 (0.5%) 0/177 (0%)
Subarachnoid hemorrhage 0/186 (0%) 1/177 (0.6%)
Syncope 0/186 (0%) 1/177 (0.6%)
Tremor 0/186 (0%) 1/177 (0.6%)
Central nervous system hemorrhage 0/186 (0%) 1/177 (0.6%)
Cerebral infarction 0/186 (0%) 1/177 (0.6%)
Hemorrhagic cerebral infarction 0/186 (0%) 1/177 (0.6%)
Psychiatric disorders
Mental status changes 1/186 (0.5%) 0/177 (0%)
Renal and urinary disorders
Hematuria 0/186 (0%) 1/177 (0.6%)
Renal failure 0/186 (0%) 1/177 (0.6%)
Respiratory, thoracic and mediastinal disorders
Pleuritic pain 1/186 (0.5%) 0/177 (0%)
Pulmonary embolism 1/186 (0.5%) 0/177 (0%)
Respiratory failure 1/186 (0.5%) 2/177 (1.1%)
Hiccups 0/186 (0%) 1/177 (0.6%)
Laryngeal hemorrhage 0/186 (0%) 1/177 (0.6%)
Pleural effusion 0/186 (0%) 4/177 (2.3%)
Pneumonia aspiration 0/186 (0%) 1/177 (0.6%)
Pneumonitis 0/186 (0%) 1/177 (0.6%)
Pneumothorax 0/186 (0%) 1/177 (0.6%)
Pulmonary artery thrombosis 0/186 (0%) 1/177 (0.6%)
Vascular disorders
Deep vein thrombosis 1/186 (0.5%) 0/177 (0%)
Hypertension 1/186 (0.5%) 2/177 (1.1%)
Arterial rupture 0/186 (0%) 1/177 (0.6%)
Other (Not Including Serious) Adverse Events
Pazopanib 800 mg Sunitinib 50 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 182/186 (97.8%) 173/177 (97.7%)
Blood and lymphatic system disorders
Neutropenia 43/186 (23.1%) 75/177 (42.4%)
Leukopenia 40/186 (21.5%) 59/177 (33.3%)
Thrombocytopenia 29/186 (15.6%) 79/177 (44.6%)
Anemia 10/186 (5.4%) 48/177 (27.1%)
Lymphopenia 3/186 (1.6%) 11/177 (6.2%)
Endocrine disorders
Hypothyroidism 29/186 (15.6%) 50/177 (28.2%)
Hyperthyroidism 3/186 (1.6%) 11/177 (6.2%)
Eye disorders
Eyelid oedema 17/186 (9.1%) 29/177 (16.4%)
Gastrointestinal disorders
Diarrhea 100/186 (53.8%) 81/177 (45.8%)
Nausea 44/186 (23.7%) 40/177 (22.6%)
Vomiting 39/186 (21%) 26/177 (14.7%)
Abdominal pain upper 29/186 (15.6%) 21/177 (11.9%)
Stomatitis 25/186 (13.4%) 53/177 (29.9%)
Abdominal pain 18/186 (9.7%) 15/177 (8.5%)
Dyspepsia 18/186 (9.7%) 23/177 (13%)
Mouth ulceration 17/186 (9.1%) 27/177 (15.3%)
Constipation 14/186 (7.5%) 31/177 (17.5%)
Abdominal discomfort 12/186 (6.5%) 16/177 (9%)
Gingivitis 12/186 (6.5%) 8/177 (4.5%)
Abdominal distension 10/186 (5.4%) 10/177 (5.6%)
Gingival bleeding 6/186 (3.2%) 9/177 (5.1%)
Toothache 5/186 (2.7%) 9/177 (5.1%)
General disorders
Fatigue 78/186 (41.9%) 89/177 (50.3%)
Pyrexia 18/186 (9.7%) 25/177 (14.1%)
Mucosal inflammation 12/186 (6.5%) 20/177 (11.3%)
Oedema peripheral 12/186 (6.5%) 20/177 (11.3%)
Oedema 8/186 (4.3%) 17/177 (9.6%)
Face oedema 7/186 (3.8%) 32/177 (18.1%)
Hepatobiliary disorders
Hyperbilirubinaemia 17/186 (9.1%) 10/177 (5.6%)
Infections and infestations
Nasopharyngitis 15/186 (8.1%) 19/177 (10.7%)
Upper respiratory tract infection 9/186 (4.8%) 11/177 (6.2%)
Investigations
Aspartate aminotransferase increased 74/186 (39.8%) 59/177 (33.3%)
Alanine aminotransferase increased 71/186 (38.2%) 55/177 (31.1%)
Blood bilirubin increased 34/186 (18.3%) 26/177 (14.7%)
Blood creatinine increased 31/186 (16.7%) 48/177 (27.1%)
Platelet count decreased 30/186 (16.1%) 58/177 (32.8%)
Blood lactate dehydrogenase increased 26/186 (14%) 43/177 (24.3%)
Neutrophil count decreased 25/186 (13.4%) 47/177 (26.6%)
White blood cell count decreased 24/186 (12.9%) 52/177 (29.4%)
Haemoglobin decreased 21/186 (11.3%) 48/177 (27.1%)
Amylase increased 20/186 (10.8%) 13/177 (7.3%)
Lipase increased 20/186 (10.8%) 18/177 (10.2%)
Blood alkaline phosphatase increased 19/186 (10.2%) 12/177 (6.8%)
Bilirubin conjugated increased 17/186 (9.1%) 6/177 (3.4%)
Blood thyroid stimulating hormone increased 17/186 (9.1%) 32/177 (18.1%)
Blood triglycerides increased 17/186 (9.1%) 22/177 (12.4%)
Gamma-glutamyltransferase increased 17/186 (9.1%) 6/177 (3.4%)
Weight decreased 17/186 (9.1%) 5/177 (2.8%)
Blood bilirubin unconjugated increased 16/186 (8.6%) 8/177 (4.5%)
Blood albumin decreased 12/186 (6.5%) 14/177 (7.9%)
Blood urea increased 9/186 (4.8%) 12/177 (6.8%)
Blood glucose increased 8/186 (4.3%) 10/177 (5.6%)
Blood phosphorus decreased 8/186 (4.3%) 11/177 (6.2%)
Haematocrit decreased 6/186 (3.2%) 12/177 (6.8%)
Red blood cell count decreased 2/186 (1.1%) 9/177 (5.1%)
Xanthochromia 1/186 (0.5%) 10/177 (5.6%)
Metabolism and nutrition disorders
Decreased appetite 77/186 (41.4%) 66/177 (37.3%)
Hyponatremia 11/186 (5.9%) 16/177 (9%)
Hypophosphatemia 11/186 (5.9%) 16/177 (9%)
Hyperglycemia 8/186 (4.3%) 15/177 (8.5%)
Hypoalbuminemia 4/186 (2.2%) 11/177 (6.2%)
Hypocalcemia 2/186 (1.1%) 11/177 (6.2%)
Hyperuricemia 0/186 (0%) 9/177 (5.1%)
Musculoskeletal and connective tissue disorders
Back pain 21/186 (11.3%) 17/177 (9.6%)
Myalgia 14/186 (7.5%) 12/177 (6.8%)
Arthralgia 13/186 (7%) 10/177 (5.6%)
Pain in extremity 13/186 (7%) 18/177 (10.2%)
Flank pain 0/186 (0%) 9/177 (5.1%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hypogeusia 9/186 (4.8%) 12/177 (6.8%)
Nervous system disorders
Headache 27/186 (14.5%) 20/177 (11.3%)
Dysgeusia 25/186 (13.4%) 37/177 (20.9%)
Dizziness 16/186 (8.6%) 17/177 (9.6%)
Psychiatric disorders
Insomnia 10/186 (5.4%) 14/177 (7.9%)
Renal and urinary disorders
Proteinuria 60/186 (32.3%) 53/177 (29.9%)
Haematuria 8/186 (4.3%) 10/177 (5.6%)
Respiratory, thoracic and mediastinal disorders
Cough 20/186 (10.8%) 23/177 (13%)
Epistaxis 14/186 (7.5%) 27/177 (15.3%)
Dysphonia 13/186 (7%) 4/177 (2.3%)
Oropharyngeal pain 11/186 (5.9%) 14/177 (7.9%)
Dyspnoea 8/186 (4.3%) 19/177 (10.7%)
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome 93/186 (50%) 114/177 (64.4%)
Hair colour changes 67/186 (36%) 14/177 (7.9%)
Rash 27/186 (14.5%) 35/177 (19.8%)
Alopecia 23/186 (12.4%) 11/177 (6.2%)
Skin hypopigmentation 16/186 (8.6%) 4/177 (2.3%)
Pruritus 4/186 (2.2%) 16/177 (9%)
Yellow skin 4/186 (2.2%) 43/177 (24.3%)
Vascular disorders
Hypertension 103/186 (55.4%) 94/177 (53.1%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.

Results Point of Contact

Name/Title Clinical Disclosure Office
Organization Novartis Pharmaceuticals
Phone 862-778-8300
Email
Responsible Party:
Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01147822
Other Study ID Numbers:
  • 113078
  • CPZP034A2201
First Posted:
Jun 22, 2010
Last Update Posted:
Dec 14, 2021
Last Verified:
Dec 1, 2021