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Sunitinib Malate Schedule 4/2 vs. Sunitinib Malate Continuous Dosing As First-Line Therapy For Metastatic Renal Cell Cancer (RCC)

Sponsor
Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT00267748
Collaborator
(none)
317
Enrollment
159
Locations
2
Arms
54
Duration (Months)
2
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This trial has two parts. The purpose of the first part of the trial is to determine the doses of 2 drugs, sunitinib malate and interferon alfa-2b, that can be given safely in combination. This part is currently closed to enrollment.

The purpose of the second part of the trial is to see if sunitinib malate given on a 4/2 schedule (4 weeks on treatment, 2 weeks off treatment cycle) is any better at delaying progression of renal cell cancer than sunitinib malate given on a continuous dosing schedule. The trial will also determine the number of patients whose cancer responds to the treatments, whether life of patients can be extended, what the side effects are of the treatments, how bothersome disease or treatment-related symptoms are to patients, and whether tests can be found that will predict which patients may or may not respond to these treatments in the future.

Condition or Disease Intervention/Treatment Phase
  • Drug: Sunitinib Malate Continuous Daily Dosing
  • Drug: Sunitinib Malate Schedule 4/2
 Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
317 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Randomized Phase II Study Of The Efficacy And Safety Of Sunitinib Malate Schedule 4/2 vs. Sunitinib Malate Continuous Dosing As First-Line Therapy For Metastatic Renal Cell Cancer (Renal EFFECT Trial)
Study Start Date :
Dec 1, 2005
Actual Primary Completion Date :
Jun 1, 2010
Actual Study Completion Date :
Jun 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Experimental: C

Drug: Sunitinib Malate Continuous Daily Dosing
Sunitinib malate starting dose 37.5 mg daily continuous daily regimen.
Experimental: A

Drug: Sunitinib Malate Schedule 4/2
Sunitinib malate starting dose 50 mg per day for four weeks, followed by a two week off-drug period. This six week cycle is repeated.

Outcome Measures

Primary Outcome Measures

  1. Time to Tumor Progression (TTP) Assessed Using Memorial Sloan-Kettering Cancer Center (MSKCC) Prognostic Factors Model [From date of randomization until the date of first documented progression or date of death due to any cause, assessed up to a maximum of 2 years]

    MSKCC Prognostic Factor Model assessed as low(0),intermediate(1-2) or high(=>3) based on number of criteria present such as Karnofsky performance status < 80 %, Lactate dehydrogenase > 1.5 * Upper limit of Normal,Hemoglobin < lower limit of normal, serum calcium > 10 mg/dL;Time from first diagnosis of renal cell carcinoma to start of systemic therapy of < 1 year.TTP was time from start of study treatment to first documentation of objective tumor progression or death due to cancer.TTP was calculated as (first event date minus date of first dose of study medication plus 1) divided by 30.44.

Secondary Outcome Measures

  1. Percentage of Participants With Objective Response (OR) [From date of randomization until the date of first documented progression or date of death due to any cause, assessed up to a maximum of 2 years]

    Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR are defined as the disappearance of all lesions (target and/or non target). PR are those with atleast 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.

  2. Duration of Response (DR) [From date of randomization until the date of first documented progression or date of death due to any cause, assessed up to a maximum of 2 years]

    Time from the first documentation of objective tumor response 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 cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 30.44. DR was calculated for the subgroup of participants with a confirmed objective tumor response.

  3. Overall Survival (OS) Assessed Using MSKCC Prognostic Factors Model [From date of randomization until the date of first documented progression or date of death due to any cause, assessed up to a maximum of 2 years]

    MSKCC Prognostic Factor Model assessed as low (0), intermediate (1-2) or high (=>3) based upon number of criteria present. Criteria as follows: Karnofsky performance status < 80 %, Lactate dehydrogenase > 1.5 * Upper limit of Normal, Hemoglobin < lower limit of normal for local lab, Corrected serum calcium > 10 mg/dL; Time from first diagnosis of renal cell carcinoma to start of systemic therapy of < 1 year. OS was defined as time from date of start of treatment to date of death due to any cause. OS, in months, was calculated as (event date -start of treatment date + 1)/30.44.

Other Outcome Measures

  1. Functional Assessment of Cancer Therapy-General (FACT-G) [From date of randomization until the date of first documented progression or date of death due to any cause, assessed up to a maximum of 2 years]

    FACT-G is core questionnaire of Functional Assessment of Chronic Illness Therapy (FACIT) measurement system to evaluate quality of life (QoL) in cancer population.FACT-G consisted of 27 questions grouped in 4 domains of general Health-Related QoL(HRQoL):Physical Well-being(PWB),Social/Family Well-Being (SWB),Emotional Well-Being (EWB) and Functional Well-Being (FWB);each ranging from 0 (not at all) to 4 (very much) so that FACT-G ranged between 0-108.Since questions could be reversed coded, as appropriate, before calculating FACT-G,0 and 108 could be considered worst and best health states.

  2. FACT-Kidney Symptom Index for Disease Related Symptoms (FKSI-DRS) [From date of randomization until the date of first documented progression or date of death due to any cause, assessed up to a maximum of 2 years]

    FKSI-DRS is a subset of FKSI which is a questionnaire for Functional Assessment of Cancer Therapy -Kidney Symptom Index used to assess QoL/participant-reported outcomes for participants diagnosed with renal cell cancer. The FKSI contained 15 questions and the FKSI-DRS consisted of 9 questions each ranging from 0 (not at all) to 4 (very much) so that FKSI-DRS ranged between 0-36. Since the questions could be reversed coded, as appropriate, before calculating FKSI-DRS, 0 and 36 could be considered the worst and best health states based on the 9 questions comprising FKSI-DRS.

Eligibility Criteria

Criteria

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

  • Advanced renal cell carcinoma of clear cell origin or a component of clear cell histology.

  • Measurable disease

Exclusion Criteria:

  • Prior systemic therapy of any kind for advanced renal cell cancer

  • History of brain metastases

  • Uncontrolled hypertension

Contacts and Locations

Locations

Site City State Country Postal Code
1 Pfizer Investigational Site Hot Springs Arkansas United States 71913
2 Pfizer Investigational Site Little Rock Arkansas United States 72205
3 Pfizer Investigational Site Anaheim California United States 92807
4 Pfizer Investigational Site Baldwin Park California United States 91706
5 Pfizer Investigational Site Bellflower California United States 90706
6 Pfizer Investigational Site Duarte California United States 91010
7 Pfizer Investigational Site Fontana California United States 92335
8 Pfizer Investigational Site Irvine California United States 92618
9 Pfizer Investigational Site Los Angeles California United States 90027
10 Pfizer Investigational Site Los Angeles California United States 90034
11 Pfizer Investigational Site Los Angeles California United States 90095
12 Pfizer Investigational Site Panorama City California United States 91402
13 Pfizer Investigational Site Riverside California United States 92505
14 Pfizer Investigational Site San Diego California United States 92108
15 Pfizer Investigational Site San Diego California United States 92120
16 Pfizer Investigational Site Woodland Hills California United States 91365
17 Pfizer Investigational Site Aurora Colorado United States 80012
18 Pfizer Investigational Site Boulder Colorado United States 80303
19 Pfizer Investigational Site Boulder Colorado United States 80304
20 Pfizer Investigational Site Colorado Springs Colorado United States 80909
21 Pfizer Investigational Site Denver Colorado United States 80218
22 Pfizer Investigational Site Denver Colorado United States 80220
23 Pfizer Investigational Site Lakewood Colorado United States 80228
24 Pfizer Investigational Site Littleton Colorado United States 80120
25 Pfizer Investigational Site Lone Tree Colorado United States 80124
26 Pfizer Investigational Site Longmont Colorado United States 80501
27 Pfizer Investigational Site Parker Colorado United States 80138
28 Pfizer Investigational Site Pueblo Colorado United States 81008
29 Pfizer Investigational Site Thorton Colorado United States 80260
30 Pfizer Investigational Site Norwich Connecticut United States 06360
31 Pfizer Investigational Site Newark Delaware United States 19713
32 Pfizer Investigational Site Newark Delaware United States 19718
33 Pfizer Investigational Site Wilmington Delaware United States 19899
34 Pfizer Investigational Site Boca Raton Florida United States 33486
35 Pfizer Investigational Site Delray Beach Florida United States 33484
36 Pfizer Investigational Site Lakeland Florida United States 33805
37 Pfizer Investigational Site Orlando Florida United States 32806
38 Pfizer Investigational Site Columbus Georgia United States 31902
39 Pfizer Investigational Site Columbus Georgia United States 31904
40 Pfizer Investigational Site Boise Idaho United States 83712
41 Pfizer Investigational Site Elkhart Indiana United States 46514
42 Pfizer Investigational Site Jefferson Indiana United States 47130
43 Pfizer Investigational Site Kokomo Indiana United States 46902-3803
44 Pfizer Investigational Site La Porte Indiana United States 46350
45 Pfizer Investigational Site LaPorte Indiana United States 46350-5533
46 Pfizer Investigational Site LaPorte Indiana United States 46350
47 Pfizer Investigational Site Michigan City Indiana United States 46360
48 Pfizer Investigational Site Plymouth Indiana United States 46563
49 Pfizer Investigational Site South Bend Indiana United States 46601
50 Pfizer Investigational Site South Bend Indiana United States 46617
51 Pfizer Investigational Site Cedar Rapids Iowa United States 52402
52 Pfizer Investigational Site Lexington Kentucky United States 40536-0293
53 Pfizer Investigational Site Lexington Kentucky United States 40536
54 Pfizer Investigational Site Louisville Kentucky United States 40202
55 Pfizer Investigational Site Louisville Kentucky United States 40207
56 Pfizer Investigational Site Louisville Kentucky United States 40217
57 Pfizer Investigational Site Shelbyville Kentucky United States 40065
58 Pfizer Investigational Site Baton Rouge Louisiana United States 70809
59 Pfizer Investigational Site Covington Louisiana United States 70433
60 Pfizer Investigational Site Gretna Louisiana United States 70056
61 Pfizer Investigational Site Marrero Louisiana United States 70072
62 Pfizer Investigational Site Metairie Louisiana United States 70006
63 Pfizer Investigational Site New Orleans Louisiana United States 70115
64 Pfizer Investigational Site Shreveport Louisiana United States 71103
65 Pfizer Investigational Site Baltimore Maryland United States 21201
66 Pfizer Investigational Site Baltimore Maryland United States 21237
67 Pfizer Investigational Site Bethesda Maryland United States 20817
68 Pfizer Investigational Site Grand Rapids Michigan United States 49503
69 Pfizer Investigational Site Holland Michigan United States 49424
70 Pfizer Investigational Site Niles Michigan United States 49120
71 Pfizer Investigational Site Saint Joseph Michigan United States 49085
72 Pfizer Investigational Site St. Joseph Michigan United States 49085-2112
73 Pfizer Investigational Site St. Joseph Michigan United States 49085-2158
74 Pfizer Investigational Site St. Joseph Michigan United States 49085
75 Pfizer Investigational Site Saint Louis Missouri United States 63141
76 Pfizer Investigational Site St. Louis Missouri United States 63141
77 Pfizer Investigational Site Washington Missouri United States 63090
78 Pfizer Investigational Site Henderson Nevada United States 89052
79 Pfizer Investigational Site Las Vegas Nevada United States 89128
80 Pfizer Investigational Site Las Vegas Nevada United States 89135
81 Pfizer Investigational Site Las Vegas Nevada United States 89148
82 Pfizer Investigational Site Las Vegas Nevada United States 89169
83 Pfizer Investigational Site Hackensack New Jersey United States 07601
84 Pfizer Investigational Site Albuquerque New Mexico United States 87131-0001
85 Pfizer Investigational Site Farmington New Mexico United States 87401-5631
86 Pfizer Investigational Site Albany New York United States 12206
87 Pfizer Investigational Site Albany New York United States 12208
88 Pfizer Investigational Site Amsterdam New York United States 12010
89 Pfizer Investigational Site Brockport New York United States 14420
90 Pfizer Investigational Site Canadaigua New York United States 14424
91 Pfizer Investigational Site Geneva New York United States 14456
92 Pfizer Investigational Site Hudson New York United States 12534
93 Pfizer Investigational Site Latham New York United States 12110
94 Pfizer Investigational Site New York New York United States 10021
95 Pfizer Investigational Site New York New York United States 10022
96 Pfizer Investigational Site New York New York United States 10032
97 Pfizer Investigational Site Rexford New York United States 12148
98 Pfizer Investigational Site Rochester New York United States 14623
99 Pfizer Investigational Site Rochester New York United States 14626
100 Pfizer Investigational Site Troy New York United States 12180
101 Pfizer Investigational Site Cary North Carolina United States 27518
102 Pfizer Investigational Site Clinton North Carolina United States 28328
103 Pfizer Investigational Site Elizabeth City North Carolina United States 27909
104 Pfizer Investigational Site Goldsboro North Carolina United States 27534
105 Pfizer Investigational Site Hickory North Carolina United States 28602
106 Pfizer Investigational Site Raleigh North Carolina United States 27607
107 Pfizer Investigational Site Raleigh North Carolina United States 27614
108 Pfizer Investigational Site Wilson North Carolina United States 27893
109 Pfizer Investigational Site Canton Ohio United States 44718
110 Pfizer Investigational Site Columbus Ohio United States 43219
111 Pfizer Investigational Site Norman Oklahoma United States 73071
112 Pfizer Investigational Site Oklahoma City Oklahoma United States 73102
113 Pfizer Investigational Site Oklahoma City Oklahoma United States 73109
114 Pfizer Investigational Site Oklahoma City Oklahoma United States 73112-4416
115 Pfizer Investigational Site Oklahoma City Oklahoma United States 73120
116 Pfizer Investigational Site Tulsa Oklahoma United States 74104
117 Pfizer Investigational Site Tulsa Oklahoma United States 74133
118 Pfizer Investigational Site Tulsa Oklahoma United States 74136-1902
119 Pfizer Investigational Site Eugene Oregon United States 97401
120 Pfizer Investigational Site Springfield Oregon United States 97477
121 Pfizer Investigational Site Dunmore Pennsylvania United States 18512-3169
122 Pfizer Investigational Site Lemoyne Pennsylvania United States 17043-1440
123 Pfizer Investigational Site Philadelphia Pennsylvania United States 19111-2497
124 Pfizer Investigational Site Scranton Pennsylvania United States 18508
125 Pfizer Investigational Site Easley South Carolina United States 29640
126 Pfizer Investigational Site Greenville South Carolina United States 29605
127 Pfizer Investigational Site Greenville South Carolina United States 29615
128 Pfizer Investigational Site Seneca South Carolina United States 29672
129 Pfizer Investigational Site Spartanburg South Carolina United States 29307
130 Pfizer Investigational Site Austin Texas United States 78705
131 Pfizer Investigational Site Austin Texas United States 78731
132 Pfizer Investigational Site Austin Texas United States 78745
133 Pfizer Investigational Site Austin Texas United States 78758
134 Pfizer Investigational Site Austin Texas United States 78759
135 Pfizer Investigational Site Bedford Texas United States 76022
136 Pfizer Investigational Site Corpus Christi Texas United States 78463
137 Pfizer Investigational Site Dallas Texas United States 75230
138 Pfizer Investigational Site Dallas Texas United States 75246
139 Pfizer Investigational Site Fort Worth Texas United States 76177
140 Pfizer Investigational Site Georgetown Texas United States 78626
141 Pfizer Investigational Site Round Rock Texas United States 78681
142 Pfizer Investigational Site San Antonio Texas United States 78207
143 Pfizer Investigational Site San Antonio Texas United States 78217
144 Pfizer Investigational Site San Antonio Texas United States 78229
145 Pfizer Investigational Site San Antonio Texas United States 78258
146 Pfizer Investigational Site Tyler Texas United States 75702
147 Pfizer Investigational Site Webster Texas United States 77598
148 Pfizer Investigational Site Salt Lake City Utah United States 84112
149 Pfizer Investigational Site Chesapeake Virginia United States 23320
150 Pfizer Investigational Site Hampton Virginia United States 23666
151 Pfizer Investigational Site Newport News Virginia United States 23502
152 Pfizer Investigational Site Newport News Virginia United States 23601
153 Pfizer Investigational Site Norfolk Virginia United States 23502
154 Pfizer Investigational Site Virginia Beach Virginia United States 23456
155 Pfizer Investigational Site Williamsburg Virginia United States 23188
156 Pfizer Investigational Site Seattle Washington United States 98109
157 Pfizer Investigational Site Seattle Washington United States 98195
158 Pfizer Investigational Site Morgantown West Virginia United States 26506
159 Pfizer Investigational Site Madison Wisconsin United States 53792

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:
, ,
ClinicalTrials.gov Identifier:
NCT00267748
Other Study ID Numbers:
  • A6181065
First Posted:
Dec 21, 2005
Last Update Posted:
Sep 5, 2011
Last Verified:
Aug 1, 2011
Additional relevant MeSH terms:
Carcinoma, Renal Cell
Sunitinib

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
Arm/Group Title Sunitinib 37.5 mg + Interferon Alpha-2b Sunitinib 50 mg (Schedule 4/2) Sunitinib 37.5 mg
Arm/Group Description Sunitinib 37.5 mg or 50 mg self administered orally once daily in the evening for 4 consecutive weeks followed by 2 weeks off (Schedule 4/2) to comprise a complete 6-weeks cycle. Concomitant Interferon (IFN) alpha-2b self-administered at a dose of 3 million units (MU) or 6 MU or 9MU subcutaneously (s.c.) 3 times weekly on non-consecutive days for up to 1 year (9 cycles) of treatment or early withdrawal. Sunitinib 50 mg self administered orally, once daily in the morning for 4 consecutive weeks followed by 2 weeks off treatment to comprise a complete 6-weeks cycle. Sunitinib 37.5 mg continuous daily dosing (CDD) self administered orally once daily in the morning.
Period Title: Non-randomized Period
STARTED 25 0 0
COMPLETED 2 0 0
NOT COMPLETED 23 0 0
Period Title: Non-randomized Period
STARTED 0 146 146
Treated 0 146 143
COMPLETED 0 19 14
NOT COMPLETED 0 127 132

Baseline Characteristics

Arm/Group Title Sunitinib 37.5 mg + Interferon Alpha-2b Sunitinib 50 mg (Schedule 4/2) Sunitinib 37.5 mg Total
Arm/Group Description Sunitinib 37.5 mg or 50 mg self administered orally once daily in the evening for 4 consecutive weeks followed by 2 weeks off (Schedule 4/2) to comprise a complete 6-weeks cycle. Concomitant Interferon (IFN) alpha-2b self-administered at a dose of 3 million units (MU) or 6 MU or 9MU subcutaneously (s.c.) 3 times weekly on non-consecutive days for up to 1 year (9 cycles) of treatment or early withdrawal. Sunitinib 50 mg self administered orally, once daily in the morning for 4 consecutive weeks followed by 2 weeks off treatment to comprise a complete 6-weeks cycle. Sunitinib 37.5 mg continuous daily dosing (CDD) self administered orally once daily in the morning. Total of all reporting groups
Overall Participants 25 146 146 317
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]
62.4
(7.2)
60.4
(9.8)
64.3
(9.7)
62.4
(9.7)
Sex: Female, Male (Count of Participants)
Female
5
20%
45
30.8%
57
39%
107
33.8%
Male
20
80%
101
69.2%
89
61%
210
66.2%

Outcome Measures

1. Primary Outcome
Title Time to Tumor Progression (TTP) Assessed Using Memorial Sloan-Kettering Cancer Center (MSKCC) Prognostic Factors Model
Description MSKCC Prognostic Factor Model assessed as low(0),intermediate(1-2) or high(=>3) based on number of criteria present such as Karnofsky performance status < 80 %, Lactate dehydrogenase > 1.5 * Upper limit of Normal,Hemoglobin < lower limit of normal, serum calcium > 10 mg/dL;Time from first diagnosis of renal cell carcinoma to start of systemic therapy of < 1 year.TTP was time from start of study treatment to first documentation of objective tumor progression or death due to cancer.TTP was calculated as (first event date minus date of first dose of study medication plus 1) divided by 30.44.
Time Frame From date of randomization until the date of first documented progression or date of death due to any cause, assessed up to a maximum of 2 years

Outcome Measure Data

Analysis Population Description
The intent-to-treat (ITT) population included all participants who were randomized into the study regardless of whether they received study medication.
Arm/Group Title Sunitinib 50 mg (Schedule 4/2) Sunitinib 37.5 mg
Arm/Group Description Sunitinib 50 mg self administered orally, once daily in the morning for 4 consecutive weeks followed by 2 weeks off treatment to comprise a complete 6-weeks cycle. Sunitinib 37.5 mg continuous daily dosing (CDD) self administered orally once daily in the morning.
Measure Participants 146 146
Stratified analysis : High Risk (=>3)
3.1
4.4
Stratified analysis : Intermediate Risk (1-2)
8.0
7.1
Stratified analysis : Low Risk (0)
20.7
8.4
Overall unstratified analysis
9.9
7.1
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sunitinib 50 mg (Schedule 4/2), Sunitinib 37.5 mg
Comments For High risk factor, the hazard ratio of TTP was estimated using stratified Cox Proportional Hazard model with the MSKCC prognostic factors (low, intermediate, high), used in the randomization, as a stratum and median TTP was estimated using Kaplan-Meier method. Log rank method was used to calculate p value.
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.860
Comments
Method Log Rank
Comments
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.089
Confidence Interval (2-Sided) 95%
0.423 to 2.803
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Sunitinib 50 mg (Schedule 4/2), Sunitinib 37.5 mg
Comments For intermediate risk factor, the hazard ratio of TTP was estimated using stratified Cox Proportional Hazard model with the MSKCC prognostic factors (low, intermediate, high), used in the randomization, as a stratum and median TTP was estimated using Kaplan-Meier method. Log rank method was used to calculate p value.
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.583
Comments
Method Log Rank
Comments
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.902
Confidence Interval (2-Sided) 95%
0.623 to 1.306
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Sunitinib 50 mg (Schedule 4/2), Sunitinib 37.5 mg
Comments For low risk factor, the hazard ratio of TTP was estimated using stratified Cox Proportional Hazard model with the MSKCC prognostic factors (low, intermediate, high), used in the randomization, as a stratum and median TTP was estimated using Kaplan-Meier method. Log rank method was used to calculate p value.
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.075
Comments
Method Log Rank
Comments
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.556
Confidence Interval (2-Sided) 95%
0.288 to 1.074
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Sunitinib 50 mg (Schedule 4/2), Sunitinib 37.5 mg
Comments For overall stratified analysis, the hazard ratio of TTP was estimated using stratified Cox Proportional Hazard model with the MSKCC prognostic factors (low, intermediate, high), used in the randomization, as a stratum and median TTP was estimated using Kaplan-Meier method. Log rank method was used to calculate p value.
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.220
Comments
Method Log Rank
Comments
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.827
Confidence Interval (2-Sided) 95%
0.609 to 1.124
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Sunitinib 50 mg (Schedule 4/2), Sunitinib 37.5 mg
Comments For overall unstratified analysis, the hazard ratio of TTP was estimated using stratified Cox Proportional Hazard model. Two-sided unstratified Log rank method was used to calculate p value.
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.090
Comments
Method Log Rank
Comments
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.773
Confidence Interval (2-Sided) 95%
0.572 to 1.044
Parameter Dispersion Type:
Value:
Estimation Comments
2. Secondary Outcome
Title Percentage of Participants With Objective Response (OR)
Description Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR are defined as the disappearance of all lesions (target and/or non target). PR are those with atleast 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.
Time Frame From date of randomization until the date of first documented progression or date of death due to any cause, assessed up to a maximum of 2 years

Outcome Measure Data

Analysis Population Description
ITT population included all participants who were randomized into the study regardless of whether they received study medication.
Arm/Group Title Sunitinib 50 mg (Schedule 4/2) Sunitinib 37.5 mg
Arm/Group Description Sunitinib 50 mg self administered orally, once daily in the morning for 4 consecutive weeks followed by 2 weeks off treatment to comprise a complete 6-weeks cycle. Sunitinib 37.5 mg continuous daily dosing (CDD) self administered orally once daily in the morning.
Measure Participants 146 146
Number (95% Confidence Interval) [Percentage of participants]
32.2
128.8%
28.1
19.2%
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sunitinib 50 mg (Schedule 4/2), Sunitinib 37.5 mg
Comments Response rate was estimated for each treatment group, 95% Confidence Interval (CI) on the difference in response rate between the 2 treatments was computed. P-value was calculated from a Pearson chi-square test.
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.444
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 4.110
Confidence Interval (2-Sided) 95%
-6.4 to 14.6
Parameter Dispersion Type:
Value:
Estimation Comments
3. Secondary Outcome
Title Duration of Response (DR)
Description Time from the first documentation of objective tumor response 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 cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 30.44. DR was calculated for the subgroup of participants with a confirmed objective tumor response.
Time Frame From date of randomization until the date of first documented progression or date of death due to any cause, assessed up to a maximum of 2 years

Outcome Measure Data

Analysis Population Description
DR was calculated for the subgroup of participants from the ITT set, with a confirmed OR.
Arm/Group Title Sunitinib 50 mg (Schedule 4/2) Sunitinib 37.5 mg
Arm/Group Description Sunitinib 50 mg self administered orally, once daily in the morning for 4 consecutive weeks followed by 2 weeks off treatment to comprise a complete 6-weeks cycle. Sunitinib 37.5 mg continuous daily dosing (CDD) self administered orally once daily in the morning.
Measure Participants 47 41
Median (Full Range) [Months]
12.5
8.7
4. Secondary Outcome
Title Overall Survival (OS) Assessed Using MSKCC Prognostic Factors Model
Description MSKCC Prognostic Factor Model assessed as low (0), intermediate (1-2) or high (=>3) based upon number of criteria present. Criteria as follows: Karnofsky performance status < 80 %, Lactate dehydrogenase > 1.5 * Upper limit of Normal, Hemoglobin < lower limit of normal for local lab, Corrected serum calcium > 10 mg/dL; Time from first diagnosis of renal cell carcinoma to start of systemic therapy of < 1 year. OS was defined as time from date of start of treatment to date of death due to any cause. OS, in months, was calculated as (event date -start of treatment date + 1)/30.44.
Time Frame From date of randomization until the date of first documented progression or date of death due to any cause, assessed up to a maximum of 2 years

Outcome Measure Data

Analysis Population Description
ITT population included all participants who were randomized into the study regardless of whether they received study medication.
Arm/Group Title Sunitinib 50 mg (Schedule 4/2) Sunitinib 37.5 mg
Arm/Group Description Sunitinib 50 mg self administered orally, once daily in the morning for 4 consecutive weeks followed by 2 weeks off treatment to comprise a complete 6-weeks cycle. Sunitinib 37.5 mg continuous daily dosing (CDD) self administered orally once daily in the morning.
Measure Participants 146 146
High Risk (equal or more than 3)
3.5
6.1
Intermediate Risk (1-2)
19.3
21.8
Low Risk (0)
NA
28.9
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sunitinib 50 mg (Schedule 4/2), Sunitinib 37.5 mg
Comments For high risk factor, the hazard ratio of OS was estimated using stratified Cox Proportional Hazard model with the MSKCC prognostic factors (low, intermediate, high), used in the randomization, as a stratum and median OS was estimated using Kaplan-Meier method. Log rank method was used to calculate p value.
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.866
Comments
Method Log Rank
Comments
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.071
Confidence Interval (2-Sided) 95%
0.481 to 2.387
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Sunitinib 50 mg (Schedule 4/2), Sunitinib 37.5 mg
Comments For intermediate risk factor,the hazard ratio of OS was estimated using stratified Cox Proportional Hazard model with the MSKCC prognostic factors (low, intermediate, high), used in the randomization, as a stratum and median OS was estimated using Kaplan-Meier method. Log rank method was used to calculate p value.
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.439
Comments
Method Log Rank
Comments
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.169
Confidence Interval (2-Sided) 95%
0.785 to 1.741
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Sunitinib 50 mg (Schedule 4/2), Sunitinib 37.5 mg
Comments For low risk factor, the hazard ratio of OS was estimated using stratified Cox Proportional Hazard model with the MSKCC prognostic factors (low, intermediate, high), used in the randomization, as a stratum and median OS was estimated using Kaplan-Meier method. Log rank method was used to calculate p value.
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.614
Comments
Method Log Rank
Comments
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.238
Confidence Interval (2-Sided) 95%
0.538 to 2.851
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Sunitinib 50 mg (Schedule 4/2), Sunitinib 37.5 mg
Comments For overall stratified analysis, the hazard ratio of OS was estimated using stratified Cox Proportional Hazard model with the MSKCC prognostic factors (low, intermediate, high), used in the randomization, as a stratum and median OS was estimated using Kaplan-Meier method. Log rank method was used to calculate p value.
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.365
Comments
Method Log Rank
Comments
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.162
Confidence Interval (2-Sided) 95%
0.838 to 1.612
Parameter Dispersion Type:
Value:
Estimation Comments
5. Other Pre-specified Outcome
Title Functional Assessment of Cancer Therapy-General (FACT-G)
Description FACT-G is core questionnaire of Functional Assessment of Chronic Illness Therapy (FACIT) measurement system to evaluate quality of life (QoL) in cancer population.FACT-G consisted of 27 questions grouped in 4 domains of general Health-Related QoL(HRQoL):Physical Well-being(PWB),Social/Family Well-Being (SWB),Emotional Well-Being (EWB) and Functional Well-Being (FWB);each ranging from 0 (not at all) to 4 (very much) so that FACT-G ranged between 0-108.Since questions could be reversed coded, as appropriate, before calculating FACT-G,0 and 108 could be considered worst and best health states.
Time Frame From date of randomization until the date of first documented progression or date of death due to any cause, assessed up to a maximum of 2 years

Outcome Measure Data

Analysis Population Description
ITT population included all participants who were randomized into the study regardless of whether they received study medication.
Arm/Group Title Sunitinib 50 mg (Schedule 4/2) Sunitinib 37.5 mg
Arm/Group Description Sunitinib 50 mg self administered orally, once daily in the morning for 4 consecutive weeks followed by 2 weeks off treatment to comprise a complete 6-weeks cycle. Sunitinib 37.5 mg continuous daily dosing (CDD) self administered orally once daily in the morning.
Measure Participants 95 103
Mean (Standard Deviation) [Units on a scale]
78.0
(15.9)
77.0
(17.1)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sunitinib 50 mg (Schedule 4/2), Sunitinib 37.5 mg
Comments P value was calculated using sample t-test.
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.6737
Comments
Method t-test, 2 sided
Comments
6. Other Pre-specified Outcome
Title FACT-Kidney Symptom Index for Disease Related Symptoms (FKSI-DRS)
Description FKSI-DRS is a subset of FKSI which is a questionnaire for Functional Assessment of Cancer Therapy -Kidney Symptom Index used to assess QoL/participant-reported outcomes for participants diagnosed with renal cell cancer. The FKSI contained 15 questions and the FKSI-DRS consisted of 9 questions each ranging from 0 (not at all) to 4 (very much) so that FKSI-DRS ranged between 0-36. Since the questions could be reversed coded, as appropriate, before calculating FKSI-DRS, 0 and 36 could be considered the worst and best health states based on the 9 questions comprising FKSI-DRS.
Time Frame From date of randomization until the date of first documented progression or date of death due to any cause, assessed up to a maximum of 2 years

Outcome Measure Data

Analysis Population Description
ITT population included all participants who were randomized into the study regardless of whether they received study medication.
Arm/Group Title Sunitinib 50 mg (Schedule 4/2) Sunitinib 37.5 mg
Arm/Group Description Sunitinib 50 mg self administered orally, once daily in the morning for 4 consecutive weeks followed by 2 weeks off treatment to comprise a complete 6-weeks cycle. Sunitinib 37.5 mg continuous daily dosing (CDD) self administered orally once daily in the morning.
Measure Participants 95 104
Mean (Standard Deviation) [Units on scale]
28.3
(5.6)
27.2
(5.9)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sunitinib 50 mg (Schedule 4/2), Sunitinib 37.5 mg
Comments P value was calculated using sample t-test.
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.1967
Comments
Method t-test, 2 sided
Comments

Adverse Events

Time Frame
Adverse Event Reporting Description The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Arm/Group Title Sunitinib 37.5 mg + Interferon Alpha-2b Sunitinib 50 mg (Schedule 4/2) Sunitinib 37.5 mg
Arm/Group Description Sunitinib 37.5 mg or 50 mg self administered orally once daily in the evening for 4 consecutive weeks followed by 2 weeks off (Schedule 4/2) to comprise a complete 6-weeks cycle. Concomitant Interferon (IFN) alpha-2b self-administered at a dose of 3 million units (MU) or 6 MU or 9MU subcutaneously (s.c.) 3 times weekly on non-consecutive days for up to 1 year (9 cycles) of treatment or early withdrawal. Sunitinib 50 mg self administered orally, once daily in the morning for 4 consecutive weeks followed by 2 weeks off treatment to comprise a complete 6-weeks cycle. Sunitinib 37.5 mg continuous daily dosing (CDD) self administered orally once daily in the morning.
All Cause Mortality
Sunitinib 37.5 mg + Interferon Alpha-2b Sunitinib 50 mg (Schedule 4/2) Sunitinib 37.5 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total / (NaN) / (NaN) / (NaN)
Serious Adverse Events
Sunitinib 37.5 mg + Interferon Alpha-2b Sunitinib 50 mg (Schedule 4/2) Sunitinib 37.5 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 7/25 (28%) 50/146 (34.2%) 54/143 (37.8%)
Blood and lymphatic system disorders
Anaemia 1/25 (4%) 3/146 (2.1%) 2/143 (1.4%)
Pancytopenia 0/25 (0%) 1/146 (0.7%) 0/143 (0%)
Disseminated intravascular coagulati 0/25 (0%) 0/146 (0%) 1/143 (0.7%)
Thrombocytopenia 0/25 (0%) 1/146 (0.7%) 2/143 (1.4%)
Febrile neutropenia 0/25 (0%) 1/146 (0.7%) 0/143 (0%)
Neutropenia 0/25 (0%) 0/146 (0%) 1/143 (0.7%)
Cardiac disorders
Myocardial infarction 1/25 (4%) 0/146 (0%) 0/143 (0%)
Atrial fibrillation 0/25 (0%) 0/146 (0%) 1/143 (0.7%)
Cardiac arrest 0/25 (0%) 2/146 (1.4%) 0/143 (0%)
Cardiac failure congestive 0/25 (0%) 2/146 (1.4%) 1/143 (0.7%)
Cardiomyopathy 0/25 (0%) 1/146 (0.7%) 0/143 (0%)
Gastrointestinal disorders
Gastrointestinal haemorrhage 1/25 (4%) 3/146 (2.1%) 3/143 (2.1%)
Haematemesis 0/25 (0%) 0/146 (0%) 1/143 (0.7%)
Rectal haemorrhage 0/25 (0%) 0/146 (0%) 1/143 (0.7%)
Upper gastrointestinal haemorrhage 0/25 (0%) 1/146 (0.7%) 0/143 (0%)
Gastritis 0/25 (0%) 1/146 (0.7%) 1/143 (0.7%)
Gastroduodenitis 0/25 (0%) 0/146 (0%) 1/143 (0.7%)
Oesophagitis 0/25 (0%) 0/146 (0%) 1/143 (0.7%)
Constipation 0/25 (0%) 0/146 (0%) 1/143 (0.7%)
Diarrhoea 0/25 (0%) 3/146 (2.1%) 1/143 (0.7%)
Abdominal pain 0/25 (0%) 1/146 (0.7%) 1/143 (0.7%)
Abdominal pain upper 0/25 (0%) 0/146 (0%) 1/143 (0.7%)
Nausea 0/25 (0%) 3/146 (2.1%) 2/143 (1.4%)
Vomiting 0/25 (0%) 3/146 (2.1%) 3/143 (2.1%)
Intestinal perforation 0/25 (0%) 0/146 (0%) 1/143 (0.7%)
Ascites 0/25 (0%) 1/146 (0.7%) 0/143 (0%)
Peritonitis 0/25 (0%) 1/146 (0.7%) 0/143 (0%)
General disorders
Pyrexia 0/25 (0%) 4/146 (2.7%) 1/143 (0.7%)
Device dislocation 0/25 (0%) 1/146 (0.7%) 0/143 (0%)
Asthenia 0/25 (0%) 3/146 (2.1%) 0/143 (0%)
Disease progression 0/25 (0%) 7/146 (4.8%) 11/143 (7.7%)
Fatigue 0/25 (0%) 1/146 (0.7%) 1/143 (0.7%)
Oedema peripheral 0/25 (0%) 0/146 (0%) 1/143 (0.7%)
Pain 0/25 (0%) 0/146 (0%) 1/143 (0.7%)
Hepatobiliary disorders
Cholecystitis 1/25 (4%) 1/146 (0.7%) 2/143 (1.4%)
Immune system disorders
Hypersensitivity 0/25 (0%) 0/146 (0%) 1/143 (0.7%)
Infections and infestations
Cellulitis 0/25 (0%) 1/146 (0.7%) 0/143 (0%)
Clostridium difficile colitis 0/25 (0%) 1/146 (0.7%) 0/143 (0%)
Abdominal wall abscess 0/25 (0%) 1/146 (0.7%) 0/143 (0%)
Bacteraemia 0/25 (0%) 0/146 (0%) 1/143 (0.7%)
Gastroenteritis 0/25 (0%) 1/146 (0.7%) 1/143 (0.7%)
Pneumonia 0/25 (0%) 3/146 (2.1%) 3/143 (2.1%)
Retroperitoneal abscess 0/25 (0%) 0/146 (0%) 1/143 (0.7%)
Sinusitis 0/25 (0%) 0/146 (0%) 1/143 (0.7%)
Subacute endocarditis 0/25 (0%) 0/146 (0%) 1/143 (0.7%)
Urinary tract infection 0/25 (0%) 3/146 (2.1%) 0/143 (0%)
Viral infection 0/25 (0%) 0/146 (0%) 1/143 (0.7%)
Injury, poisoning and procedural complications
Compression fracture 0/25 (0%) 1/146 (0.7%) 0/143 (0%)
Femur fracture 0/25 (0%) 1/146 (0.7%) 1/143 (0.7%)
Hip fracture 0/25 (0%) 0/146 (0%) 1/143 (0.7%)
Meniscus lesion 0/25 (0%) 1/146 (0.7%) 0/143 (0%)
Fall 0/25 (0%) 1/146 (0.7%) 1/143 (0.7%)
Investigations
Haemoglobin decreased 1/25 (4%) 0/146 (0%) 0/143 (0%)
Metabolism and nutrition disorders
Dehydration 1/25 (4%) 6/146 (4.1%) 12/143 (8.4%)
Hypercalcaemia 1/25 (4%) 2/146 (1.4%) 0/143 (0%)
Hypocalcaemia 1/25 (4%) 0/146 (0%) 0/143 (0%)
Hypoglycaemia 1/25 (4%) 0/146 (0%) 2/143 (1.4%)
Hypokalaemia 1/25 (4%) 0/146 (0%) 0/143 (0%)
Hyponatraemia 0/25 (0%) 1/146 (0.7%) 5/143 (3.5%)
Hypovolaemia 0/25 (0%) 1/146 (0.7%) 0/143 (0%)
Musculoskeletal and connective tissue disorders
Pathological fracture 0/25 (0%) 0/146 (0%) 1/143 (0.7%)
Muscular weakness 0/25 (0%) 2/146 (1.4%) 2/143 (1.4%)
Spinal column stenosis 0/25 (0%) 1/146 (0.7%) 0/143 (0%)
Back pain 0/25 (0%) 0/146 (0%) 2/143 (1.4%)
Musculoskeletal chest pain 0/25 (0%) 1/146 (0.7%) 0/143 (0%)
Musculoskeletal pain 0/25 (0%) 0/146 (0%) 1/143 (0.7%)
Pain in extremity 0/25 (0%) 0/146 (0%) 1/143 (0.7%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain 0/25 (0%) 0/146 (0%) 1/143 (0.7%)
Multiple myeloma 0/25 (0%) 1/146 (0.7%) 0/143 (0%)
Nervous system disorders
Convulsion 1/25 (4%) 0/146 (0%) 0/143 (0%)
Syncope 1/25 (4%) 1/146 (0.7%) 3/143 (2.1%)
Cerebral ischaemia 0/25 (0%) 2/146 (1.4%) 0/143 (0%)
Cerebrovascular accident 0/25 (0%) 1/146 (0.7%) 0/143 (0%)
Embolic stroke 0/25 (0%) 0/146 (0%) 1/143 (0.7%)
Haemorrhage intracranial 0/25 (0%) 0/146 (0%) 1/143 (0.7%)
Transient ischaemic attack 0/25 (0%) 1/146 (0.7%) 1/143 (0.7%)
Demyelination 0/25 (0%) 0/146 (0%) 1/143 (0.7%)
Headache 0/25 (0%) 0/146 (0%) 1/143 (0.7%)
Dizziness 0/25 (0%) 1/146 (0.7%) 2/143 (1.4%)
Presyncope 0/25 (0%) 0/146 (0%) 1/143 (0.7%)
Psychiatric disorders
Confusional state 0/25 (0%) 1/146 (0.7%) 1/143 (0.7%)
Delirium 0/25 (0%) 0/146 (0%) 1/143 (0.7%)
Mental status changes 0/25 (0%) 2/146 (1.4%) 0/143 (0%)
Renal and urinary disorders
Bladder neck obstruction 0/25 (0%) 1/146 (0.7%) 0/143 (0%)
Renal failure 0/25 (0%) 0/146 (0%) 2/143 (1.4%)
Renal failure acute 0/25 (0%) 2/146 (1.4%) 4/143 (2.8%)
Renal haemorrhage 0/25 (0%) 0/146 (0%) 1/143 (0.7%)
Haematuria 0/25 (0%) 1/146 (0.7%) 3/143 (2.1%)
Respiratory, thoracic and mediastinal disorders
Pleural effusion 1/25 (4%) 2/146 (1.4%) 3/143 (2.1%)
Pneumonia aspiration 0/25 (0%) 0/146 (0%) 2/143 (1.4%)
Pulmonary embolism 0/25 (0%) 3/146 (2.1%) 2/143 (1.4%)
Aspiration 0/25 (0%) 1/146 (0.7%) 0/143 (0%)
Cough 0/25 (0%) 1/146 (0.7%) 0/143 (0%)
Dyspnoea 0/25 (0%) 2/146 (1.4%) 4/143 (2.8%)
Hypoxia 0/25 (0%) 1/146 (0.7%) 0/143 (0%)
Epistaxis 0/25 (0%) 0/146 (0%) 1/143 (0.7%)
Skin and subcutaneous tissue disorders
Angioedema 0/25 (0%) 0/146 (0%) 1/143 (0.7%)
Panniculitis 0/25 (0%) 1/146 (0.7%) 0/143 (0%)
Surgical and medical procedures
Wound drainage 0/25 (0%) 1/146 (0.7%) 0/143 (0%)
Vascular disorders
Hypertension 1/25 (4%) 2/146 (1.4%) 2/143 (1.4%)
Aortic dissection 0/25 (0%) 0/146 (0%) 1/143 (0.7%)
Arterial insufficiency 0/25 (0%) 1/146 (0.7%) 0/143 (0%)
Hypotension 0/25 (0%) 0/146 (0%) 4/143 (2.8%)
Orthostatic hypotension 0/25 (0%) 1/146 (0.7%) 0/143 (0%)
Shock 0/25 (0%) 1/146 (0.7%) 0/143 (0%)
Microangiopathy 0/25 (0%) 1/146 (0.7%) 0/143 (0%)
Other (Not Including Serious) Adverse Events
Sunitinib 37.5 mg + Interferon Alpha-2b Sunitinib 50 mg (Schedule 4/2) Sunitinib 37.5 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 25/25 (100%) 144/146 (98.6%) 142/143 (99.3%)
Blood and lymphatic system disorders
Neutropenia 14/25 (56%) 24/146 (16.4%) 19/143 (13.3%)
Thrombocytopenia 9/25 (36%) 35/146 (24%) 28/143 (19.6%)
Leukopenia 7/25 (28%) 8/146 (5.5%) 5/143 (3.5%)
Anaemia 5/25 (20%) 25/146 (17.1%) 27/143 (18.9%)
Lymphopenia 3/25 (12%) 0/146 (0%) 0/143 (0%)
Endocrine disorders
Hypothyroidism 0/25 (0%) 19/146 (13%) 11/143 (7.7%)
Eye disorders
Lacrimation increased 0/25 (0%) 8/146 (5.5%) 7/143 (4.9%)
Gastrointestinal disorders
Diarrhoea 20/25 (80%) 85/146 (58.2%) 98/143 (68.5%)
Nausea 14/25 (56%) 91/146 (62.3%) 76/143 (53.1%)
Stomatitis 13/25 (52%) 32/146 (21.9%) 33/143 (23.1%)
Dyspepsia 10/25 (40%) 37/146 (25.3%) 36/143 (25.2%)
Vomiting 8/25 (32%) 48/146 (32.9%) 48/143 (33.6%)
Constipation 5/25 (20%) 40/146 (27.4%) 39/143 (27.3%)
Abdominal pain 4/25 (16%) 16/146 (11%) 15/143 (10.5%)
Oral pain 4/25 (16%) 19/146 (13%) 18/143 (12.6%)
Gastrooesophageal reflux disease 3/25 (12%) 19/146 (13%) 7/143 (4.9%)
Abdominal distension 2/25 (8%) 12/146 (8.2%) 2/143 (1.4%)
Glossitis 2/25 (8%) 0/146 (0%) 0/143 (0%)
Glossodynia 2/25 (8%) 10/146 (6.8%) 7/143 (4.9%)
Rectal haemorrhage 2/25 (8%) 7/146 (4.8%) 8/143 (5.6%)
Abdominal pain upper 0/25 (0%) 11/146 (7.5%) 9/143 (6.3%)
Dry mouth 0/25 (0%) 11/146 (7.5%) 12/143 (8.4%)
Dysphagia 0/25 (0%) 12/146 (8.2%) 5/143 (3.5%)
Flatulence 0/25 (0%) 10/146 (6.8%) 12/143 (8.4%)
Haemorrhoids 0/25 (0%) 6/146 (4.1%) 8/143 (5.6%)
Toothache 0/25 (0%) 8/146 (5.5%) 3/143 (2.1%)
General disorders
Fatigue 25/25 (100%) 94/146 (64.4%) 100/143 (69.9%)
Pyrexia 8/25 (32%) 23/146 (15.8%) 17/143 (11.9%)
Chills 7/25 (28%) 14/146 (9.6%) 18/143 (12.6%)
Influenza like illness 6/25 (24%) 0/146 (0%) 0/143 (0%)
Mucosal inflammation 2/25 (8%) 41/146 (28.1%) 36/143 (25.2%)
Oedema peripheral 2/25 (8%) 29/146 (19.9%) 26/143 (18.2%)
Asthenia 0/25 (0%) 13/146 (8.9%) 16/143 (11.2%)
Chest pain 0/25 (0%) 7/146 (4.8%) 8/143 (5.6%)
Pain 0/25 (0%) 4/146 (2.7%) 13/143 (9.1%)
Infections and infestations
Urinary tract infection 2/25 (8%) 10/146 (6.8%) 8/143 (5.6%)
Sinusitis 0/25 (0%) 11/146 (7.5%) 3/143 (2.1%)
Upper respiratory tract infection 0/25 (0%) 12/146 (8.2%) 5/143 (3.5%)
Injury, poisoning and procedural complications
Contusion 0/25 (0%) 8/146 (5.5%) 12/143 (8.4%)
Investigations
Alanine aminotransferase increased 3/25 (12%) 0/146 (0%) 0/143 (0%)
Weight decreased 3/25 (12%) 20/146 (13.7%) 30/143 (21%)
Aspartate aminotransferase increased 2/25 (8%) 0/146 (0%) 0/143 (0%)
White blood cell count decreased 2/25 (8%) 0/146 (0%) 0/143 (0%)
Blood creatinine increased 0/25 (0%) 11/146 (7.5%) 11/143 (7.7%)
Haemoglobin decreased 0/25 (0%) 6/146 (4.1%) 11/143 (7.7%)
Metabolism and nutrition disorders
Decreased appetite 11/25 (44%) 46/146 (31.5%) 59/143 (41.3%)
Dehydration 0/25 (0%) 10/146 (6.8%) 21/143 (14.7%)
Hypokalaemia 0/25 (0%) 5/146 (3.4%) 8/143 (5.6%)
Musculoskeletal and connective tissue disorders
Arthralgia 6/25 (24%) 20/146 (13.7%) 25/143 (17.5%)
Myalgia 6/25 (24%) 14/146 (9.6%) 11/143 (7.7%)
Pain in extremity 3/25 (12%) 32/146 (21.9%) 23/143 (16.1%)
Back pain 2/25 (8%) 29/146 (19.9%) 24/143 (16.8%)
Muscle spasms 0/25 (0%) 13/146 (8.9%) 6/143 (4.2%)
Musculoskeletal chest pain 0/25 (0%) 5/146 (3.4%) 8/143 (5.6%)
Musculoskeletal pain 0/25 (0%) 9/146 (6.2%) 9/143 (6.3%)
Nervous system disorders
Dysgeusia 7/25 (28%) 55/146 (37.7%) 49/143 (34.3%)
Dizziness 6/25 (24%) 22/146 (15.1%) 20/143 (14%)
Headache 5/25 (20%) 33/146 (22.6%) 23/143 (16.1%)
Paraesthesia 5/25 (20%) 0/146 (0%) 0/143 (0%)
Ageusia 2/25 (8%) 0/146 (0%) 0/143 (0%)
Psychiatric disorders
Anxiety 0/25 (0%) 14/146 (9.6%) 11/143 (7.7%)
Depression 0/25 (0%) 10/146 (6.8%) 18/143 (12.6%)
Insomnia 0/25 (0%) 27/146 (18.5%) 22/143 (15.4%)
Renal and urinary disorders
Pollakiuria 2/25 (8%) 0/146 (0%) 0/143 (0%)
Respiratory, thoracic and mediastinal disorders
Dyspnoea 10/25 (40%) 29/146 (19.9%) 26/143 (18.2%)
Epistaxis 6/25 (24%) 34/146 (23.3%) 25/143 (17.5%)
Dyspnoea exertional 4/25 (16%) 0/146 (0%) 0/143 (0%)
Cough 2/25 (8%) 29/146 (19.9%) 31/143 (21.7%)
Oropharyngeal pain 0/25 (0%) 11/146 (7.5%) 13/143 (9.1%)
Skin and subcutaneous tissue disorders
Dry skin 7/25 (28%) 22/146 (15.1%) 20/143 (14%)
Palmar-plantar erythrodysaesthesia syndrome 6/25 (24%) 46/146 (31.5%) 36/143 (25.2%)
Rash 6/25 (24%) 36/146 (24.7%) 44/143 (30.8%)
Pruritus 4/25 (16%) 10/146 (6.8%) 10/143 (7%)
Yellow skin 4/25 (16%) 8/146 (5.5%) 7/143 (4.9%)
Hair colour changes 2/25 (8%) 18/146 (12.3%) 21/143 (14.7%)
Night sweats 2/25 (8%) 0/146 (0%) 0/143 (0%)
Alopecia 0/25 (0%) 8/146 (5.5%) 16/143 (11.2%)
Erythema 0/25 (0%) 12/146 (8.2%) 7/143 (4.9%)
Periorbital oedema 0/25 (0%) 9/146 (6.2%) 7/143 (4.9%)
Skin discolouration 0/25 (0%) 10/146 (6.8%) 3/143 (2.1%)
Skin lesion 0/25 (0%) 9/146 (6.2%) 5/143 (3.5%)
Vascular disorders
Hypertension 6/25 (24%) 46/146 (31.5%) 42/143 (29.4%)
Accelerated hypertension 2/25 (8%) 0/146 (0%) 0/143 (0%)

Limitations/Caveats

[Not Specified]

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
Email ClinicalTrials.gov_Inquiries@pfizer.com
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00267748
Other Study ID Numbers:
  • A6181065
First Posted:
Dec 21, 2005
Last Update Posted:
Sep 5, 2011
Last Verified:
Aug 1, 2011