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Sunitinib Plus Prednisone In Patients With Metastatic Castration-Resistant Prostate Cancer After Failure Of Docetaxel Chemotherapy (SUN 1120)

Primary Purpose

Prostatic Neoplasms

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Prednisone
sunitinib
Placebo
Prednisone
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostatic Neoplasms focused on measuring Docetaxel-refractory mCRPC, Second-line treatment with sunitinib and prednisone

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Histologically or cytologically confirmed adenocarcinoma of the prostate.
  • Progressive, metastatic castration-resistant prostate cancer after failure of docetaxel chemotherapy (resistant or intolerant).
  • Progressive disease based on PSA progression, RECIST, or positive bone scan.
  • ECOG 0 or 1.

Exclusion Criteria:

  • Prior treatment with sunitinib and/or more than 1 prior chemotherapy regimen in the metastatic disease setting.
  • Chemotherapy within 3 weeks.
  • Impending complications from bone metastases.
  • Ongoing urinary obstruction.
  • Cardiac dysfunction, QTc >470 msec.
  • CNS involvement.

Sites / Locations

  • Pfizer Investigational Site
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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

A

B

Arm Description

Treatment Arm A - sunitinib + prednisone

Treatment Arm B - placebo + prednisone

Outcomes

Primary Outcome Measures

Overall Survival (OS)
OS is the duration from randomization to death. For participants who were alive, overall survival was censored at the last contact. OS (in months) calculated as (date of death minus [-] date of randomization plus [+] 1) divided (/) 30.4.

Secondary Outcome Measures

Progression-Free Survival (PFS)
PFS is the period from randomization until disease progression or death on study. PFS is censored on the date of last tumor assessment documenting absence of progressive disease. PFS (weeks) calculated as (first event date - randomization date + 1)/7.02
Percent of Participants With Objective Response (OR)
OR defined as the percent (%) of participants with confirmed Complete Response (CR) (disappearance of all target lesions) or Partial Response (PR) (>=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions) according to Response Evaluation Criteria in Solid Tumors (RECIST), relative to the full analysis population. Confirmed responses were those that persist on repeat imagining study >= 4 weeks after initial documentation of response.
Duration of Response (DR)
Time in weeks 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 cause - the date of the first CR or PR that was subsequently confirmed plus 1 divided by 7.02. DR calculated for the subgroup of participants with a confirmed objective tumor response
Change From Baseline in Pain Severity
Pain severity recorded on a numerical scale ranging from 0 (no pain) to 10 (pain as bad as you can imagine). Higher scores indicated greater level of pain. The pain score for each cycle averaged for the 7 days.
Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P)
FACT-P is a validated, self-administered instrument used to assess health-related quality of life and prostate cancer-specific symptoms. Scores ranged from 0 (not at all) to 4 (very much). It is 27-item FACT-General and 12 items for the prostate cancer specific concerns. The 27 items in FACT-G are grouped into 4 domains: physical well-being, social/family well-being, emotional well-being and functional well-being. The 12 prostate cancer symptoms items focus on pain (3 items), urination problems (3 items), sexual functions (2 items), weight loss, appetite, overall comfort, and bowel movement.
Change From Baseline in Euro Quality of Life (EQ-5D)- Health State Profile Utility Score
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"). Overall scores range from 0 to 1, with lower scores representing a higher level of dysfunction.

Full Information

First Posted
May 8, 2008
Last Updated
February 5, 2013
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00676650
Brief Title
Sunitinib Plus Prednisone In Patients With Metastatic Castration-Resistant Prostate Cancer After Failure Of Docetaxel Chemotherapy
Acronym
SUN 1120
Official Title
A Multicenter, Randomized, Double-Blind, Phase 3 Study Of Sunitinib Plus Prednisone Versus Prednisone In Patients With Progressive Metastatic Castration-Resistant Prostate Cancer After Failure Of A Docetaxel-Based Chemotherapy Regimen
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Terminated
Why Stopped
Study A6181120 was prematurely discontinued due to futility on 27 September 2010. No new or unexpected safety issues were identified.
Study Start Date
July 2008 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study will compare the safety and efficacy of sunitinib in combination with prednisone versus placebo and prednisone in patients that have metastatic castration-resistant prostate cancer that has progressed after treatment with a docetaxel-containing chemotherapy regimen. This is a second-line study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Neoplasms
Keywords
Docetaxel-refractory mCRPC, Second-line treatment with sunitinib and prednisone

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
873 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
Treatment Arm A - sunitinib + prednisone
Arm Title
B
Arm Type
Placebo Comparator
Arm Description
Treatment Arm B - placebo + prednisone
Intervention Type
Drug
Intervention Name(s)
Prednisone
Other Intervention Name(s)
Deltasone
Intervention Description
5 mg BID, oral
Intervention Type
Drug
Intervention Name(s)
sunitinib
Other Intervention Name(s)
Sutent, SU011248
Intervention Description
37.5 mg/day, oral, administered on a continuous daily dosing regimen
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
37.5 mg/day, oral, administered on a continuous daily dosing regimen
Intervention Type
Drug
Intervention Name(s)
Prednisone
Other Intervention Name(s)
Deltasone
Intervention Description
5 mg BID, oral
Primary Outcome Measure Information:
Title
Overall Survival (OS)
Description
OS is the duration from randomization to death. For participants who were alive, overall survival was censored at the last contact. OS (in months) calculated as (date of death minus [-] date of randomization plus [+] 1) divided (/) 30.4.
Time Frame
Baseline up to 32 months
Secondary Outcome Measure Information:
Title
Progression-Free Survival (PFS)
Description
PFS is the period from randomization until disease progression or death on study. PFS is censored on the date of last tumor assessment documenting absence of progressive disease. PFS (weeks) calculated as (first event date - randomization date + 1)/7.02
Time Frame
Baseline, every 8 weeks up to 123 weeks
Title
Percent of Participants With Objective Response (OR)
Description
OR defined as the percent (%) of participants with confirmed Complete Response (CR) (disappearance of all target lesions) or Partial Response (PR) (>=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions) according to Response Evaluation Criteria in Solid Tumors (RECIST), relative to the full analysis population. Confirmed responses were those that persist on repeat imagining study >= 4 weeks after initial documentation of response.
Time Frame
Baseline, every 8 weeks up to 123 weeks
Title
Duration of Response (DR)
Description
Time in weeks 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 cause - the date of the first CR or PR that was subsequently confirmed plus 1 divided by 7.02. DR calculated for the subgroup of participants with a confirmed objective tumor response
Time Frame
Baseline, every 8 weeks up to 123 weeks
Title
Change From Baseline in Pain Severity
Description
Pain severity recorded on a numerical scale ranging from 0 (no pain) to 10 (pain as bad as you can imagine). Higher scores indicated greater level of pain. The pain score for each cycle averaged for the 7 days.
Time Frame
Day 1 through Day 7 every 28 days (every cycle) up to 29 months
Title
Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P)
Description
FACT-P is a validated, self-administered instrument used to assess health-related quality of life and prostate cancer-specific symptoms. Scores ranged from 0 (not at all) to 4 (very much). It is 27-item FACT-General and 12 items for the prostate cancer specific concerns. The 27 items in FACT-G are grouped into 4 domains: physical well-being, social/family well-being, emotional well-being and functional well-being. The 12 prostate cancer symptoms items focus on pain (3 items), urination problems (3 items), sexual functions (2 items), weight loss, appetite, overall comfort, and bowel movement.
Time Frame
Baseline, every 4 weeks up to 123 weeks
Title
Change From Baseline in Euro Quality of Life (EQ-5D)- Health State Profile Utility Score
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"). Overall scores range from 0 to 1, with lower scores representing a higher level of dysfunction.
Time Frame
Baseline, every 4 weeks up to 123 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically or cytologically confirmed adenocarcinoma of the prostate. Progressive, metastatic castration-resistant prostate cancer after failure of docetaxel chemotherapy (resistant or intolerant). Progressive disease based on PSA progression, RECIST, or positive bone scan. ECOG 0 or 1. Exclusion Criteria: Prior treatment with sunitinib and/or more than 1 prior chemotherapy regimen in the metastatic disease setting. Chemotherapy within 3 weeks. Impending complications from bone metastases. Ongoing urinary obstruction. Cardiac dysfunction, QTc >470 msec. CNS involvement.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Decatur
State/Province
Alabama
ZIP/Postal Code
35601
Country
United States
Facility Name
Pfizer Investigational Site
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Pfizer Investigational Site
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35805
Country
United States
Facility Name
Pfizer Investigational Site
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Pfizer Investigational Site
City
Encinitas
State/Province
California
ZIP/Postal Code
92024
Country
United States
Facility Name
Pfizer Investigational Site
City
Glendale
State/Province
California
ZIP/Postal Code
91206
Country
United States
Facility Name
Pfizer Investigational Site
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Pfizer Investigational Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Pfizer Investigational Site
City
Modesto
State/Province
California
ZIP/Postal Code
95355
Country
United States
Facility Name
Pfizer Investigational Site
City
Thousand Oaks
State/Province
California
ZIP/Postal Code
91360
Country
United States
Facility Name
Pfizer Investigational Site
City
Thousands Oaks
State/Province
California
ZIP/Postal Code
91360
Country
United States
Facility Name
Pfizer Investigational Site
City
Vista
State/Province
California
ZIP/Postal Code
92083
Country
United States
Facility Name
Pfizer Investigational Site
City
Westlake Village
State/Province
California
ZIP/Postal Code
91361
Country
United States
Facility Name
Pfizer Investigational Site
City
Denver
State/Province
Colorado
ZIP/Postal Code
80205
Country
United States
Facility Name
Pfizer Investigational Site
City
Lafayette
State/Province
Colorado
ZIP/Postal Code
80025
Country
United States
Facility Name
Pfizer Investigational Site
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32605
Country
United States
Facility Name
Pfizer Investigational Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Pfizer Investigational Site
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Facility Name
Pfizer Investigational Site
City
Arlington Heights
State/Province
Illinois
ZIP/Postal Code
60005
Country
United States
Facility Name
Pfizer Investigational Site
City
Niles
State/Province
Illinois
ZIP/Postal Code
60714
Country
United States
Facility Name
Pfizer Investigational Site
City
Winfield
State/Province
Illinois
ZIP/Postal Code
60190
Country
United States
Facility Name
Pfizer Investigational Site
City
Zion
State/Province
Illinois
ZIP/Postal Code
60099
Country
United States
Facility Name
Pfizer Investigational Site
City
Carmel
State/Province
Indiana
ZIP/Postal Code
46032
Country
United States
Facility Name
Pfizer Investigational Site
City
Fishers
State/Province
Indiana
ZIP/Postal Code
46037
Country
United States
Facility Name
Pfizer Investigational Site
City
Greenfield
State/Province
Indiana
ZIP/Postal Code
46140
Country
United States
Facility Name
Pfizer Investigational Site
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46219
Country
United States
Facility Name
Pfizer Investigational Site
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46227
Country
United States
Facility Name
Pfizer Investigational Site
City
Lafayette
State/Province
Indiana
ZIP/Postal Code
47905
Country
United States
Facility Name
Pfizer Investigational Site
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40207
Country
United States
Facility Name
Pfizer Investigational Site
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Pfizer Investigational Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Pfizer Investigational Site
City
Danvers
State/Province
Massachusetts
ZIP/Postal Code
01923
Country
United States
Facility Name
Pfizer Investigational Site
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Pfizer Investigational Site
City
St. Cloud
State/Province
Minnesota
ZIP/Postal Code
56303-5000
Country
United States
Facility Name
Pfizer Investigational Site
City
Corinth
State/Province
Mississippi
ZIP/Postal Code
38834
Country
United States
Facility Name
Pfizer Investigational Site
City
Southaven
State/Province
Mississippi
ZIP/Postal Code
38671
Country
United States
Facility Name
Pfizer Investigational Site
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68506
Country
United States
Facility Name
Pfizer Investigational Site
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Pfizer Investigational Site
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89052
Country
United States
Facility Name
Pfizer Investigational Site
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89074
Country
United States
Facility Name
Pfizer Investigational Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
Pfizer Investigational Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89148
Country
United States
Facility Name
Pfizer Investigational Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89169
Country
United States
Facility Name
Pfizer Investigational Site
City
Sewell
State/Province
New Jersey
ZIP/Postal Code
08080
Country
United States
Facility Name
Pfizer Investigational Site
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Pfizer Investigational Site
City
Bronx
State/Province
New York
ZIP/Postal Code
10467-2401
Country
United States
Facility Name
Pfizer Investigational Site
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Pfizer Investigational Site
City
Cary
State/Province
North Carolina
ZIP/Postal Code
27518
Country
United States
Facility Name
Pfizer Investigational Site
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Pfizer Investigational Site
City
Kernersville
State/Province
North Carolina
ZIP/Postal Code
27284
Country
United States
Facility Name
Pfizer Investigational Site
City
Lexington
State/Province
North Carolina
ZIP/Postal Code
27295
Country
United States
Facility Name
Pfizer Investigational Site
City
Mount Airy
State/Province
North Carolina
ZIP/Postal Code
27030
Country
United States
Facility Name
Pfizer Investigational Site
City
North Wilkesboro
State/Province
North Carolina
ZIP/Postal Code
28659
Country
United States
Facility Name
Pfizer Investigational Site
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
Pfizer Investigational Site
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27614
Country
United States
Facility Name
Pfizer Investigational Site
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Pfizer Investigational Site
City
Bismarck
State/Province
North Dakota
ZIP/Postal Code
58501
Country
United States
Facility Name
Pfizer Investigational Site
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Pfizer Investigational Site
City
Mayfield Heights
State/Province
Ohio
ZIP/Postal Code
44124
Country
United States
Facility Name
Pfizer Investigational Site
City
Mentor
State/Province
Ohio
ZIP/Postal Code
44060
Country
United States
Facility Name
Pfizer Investigational Site
City
Orange Village
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
Pfizer Investigational Site
City
Westlake
State/Province
Ohio
ZIP/Postal Code
44145
Country
United States
Facility Name
Pfizer Investigational Site
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
Pfizer Investigational Site
City
Springfield
State/Province
Oregon
ZIP/Postal Code
97477
Country
United States
Facility Name
Pfizer Investigational Site
City
Clairton
State/Province
Pennsylvania
ZIP/Postal Code
15025
Country
United States
Facility Name
Pfizer Investigational Site
City
Greensburg
State/Province
Pennsylvania
ZIP/Postal Code
15601
Country
United States
Facility Name
Pfizer Investigational Site
City
Johnstown
State/Province
Pennsylvania
ZIP/Postal Code
15901
Country
United States
Facility Name
Pfizer Investigational Site
City
Kingston
State/Province
Pennsylvania
ZIP/Postal Code
18704
Country
United States
Facility Name
Pfizer Investigational Site
City
Lancaster
State/Province
Pennsylvania
ZIP/Postal Code
17604
Country
United States
Facility Name
Pfizer Investigational Site
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15215
Country
United States
Facility Name
Pfizer Investigational Site
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
Pfizer Investigational Site
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15237
Country
United States
Facility Name
Pfizer Investigational Site
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15241
Country
United States
Facility Name
Pfizer Investigational Site
City
Uniontown
State/Province
Pennsylvania
ZIP/Postal Code
15401
Country
United States
Facility Name
Pfizer Investigational Site
City
Wexford
State/Province
Pennsylvania
ZIP/Postal Code
15090
Country
United States
Facility Name
Pfizer Investigational Site
City
Brighton
State/Province
Tennessee
ZIP/Postal Code
38011
Country
United States
Facility Name
Pfizer Investigational Site
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38104
Country
United States
Facility Name
Pfizer Investigational Site
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Facility Name
Pfizer Investigational Site
City
Arlington
State/Province
Texas
ZIP/Postal Code
76014
Country
United States
Facility Name
Pfizer Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Pfizer Investigational Site
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76177
Country
United States
Facility Name
Pfizer Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Pfizer Investigational Site
City
Webster
State/Province
Texas
ZIP/Postal Code
77598
Country
United States
Facility Name
Pfizer Investigational Site
City
Everett
State/Province
Washington
ZIP/Postal Code
98201
Country
United States
Facility Name
Pfizer Investigational Site
City
Monroe
State/Province
Washington
ZIP/Postal Code
98272
Country
United States
Facility Name
Pfizer Investigational Site
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
Pfizer Investigational Site
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Pfizer Investigational Site
City
Port Macquarie
State/Province
New South Wales
ZIP/Postal Code
2444
Country
Australia
Facility Name
Pfizer Investigational Site
City
Wahroong
State/Province
New South Wales
ZIP/Postal Code
2076
Country
Australia
Facility Name
Pfizer Investigational Site
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Pfizer Investigational Site
City
Wodonga
State/Province
Victoria
ZIP/Postal Code
3690
Country
Australia
Facility Name
Pfizer Investigational Site
City
Bruxelles
ZIP/Postal Code
1000
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Liege
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Mons
ZIP/Postal Code
7000
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Namur
ZIP/Postal Code
5000
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Wilrijk
ZIP/Postal Code
2610
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Salvador
State/Province
BA
ZIP/Postal Code
40170-110
Country
Brazil
Facility Name
Pfizer Investigational Site
City
Belo Horizonte
State/Province
MG
ZIP/Postal Code
30150-281
Country
Brazil
Facility Name
Pfizer Investigational Site
City
Rio de Janeiro
State/Province
RJ
ZIP/Postal Code
22260-020
Country
Brazil
Facility Name
Pfizer Investigational Site
City
Caxias do Sul
State/Province
RS
ZIP/Postal Code
95070-560
Country
Brazil
Facility Name
Pfizer Investigational Site
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90050-170
Country
Brazil
Facility Name
Pfizer Investigational Site
City
Santo André
State/Province
SP
ZIP/Postal Code
09060-650
Country
Brazil
Facility Name
Pfizer Investigational Site
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1Y 5L3
Country
Canada
Facility Name
Pfizer Investigational Site
City
Barrie
State/Province
Ontario
ZIP/Postal Code
L4M 6M2
Country
Canada
Facility Name
Pfizer Investigational Site
City
Oshawa
State/Province
Ontario
ZIP/Postal Code
L1G 2B9
Country
Canada
Facility Name
Pfizer Investigational Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 4M1
Country
Canada
Facility Name
Pfizer Investigational Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3G 1A4
Country
Canada
Facility Name
Pfizer Investigational Site
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
Facility Name
Pfizer Investigational Site
City
WuHan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
Facility Name
Pfizer Investigational Site
City
Beijing
ZIP/Postal Code
100036
Country
China
Facility Name
Pfizer Investigational Site
City
Chongqing
ZIP/Postal Code
400038
Country
China
Facility Name
Pfizer Investigational Site
City
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Name
Pfizer Investigational Site
City
Shanghai
ZIP/Postal Code
200433
Country
China
Facility Name
Pfizer Investigational Site
City
Brno
ZIP/Postal Code
625 00
Country
Czech Republic
Facility Name
Pfizer Investigational Site
City
Olomouc
ZIP/Postal Code
775 20
Country
Czech Republic
Facility Name
Pfizer Investigational Site
City
Usti nad Labem
ZIP/Postal Code
40113
Country
Czech Republic
Facility Name
Pfizer Investigational Site
City
Herlev
ZIP/Postal Code
2730
Country
Denmark
Facility Name
Pfizer Investigational Site
City
Koebenhavn Oe
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Pfizer Investigational Site
City
Odense C
ZIP/Postal Code
5000
Country
Denmark
Facility Name
Pfizer Investigational Site
City
Vejle
ZIP/Postal Code
7100
Country
Denmark
Facility Name
Pfizer Investigational Site
City
Helsinki
ZIP/Postal Code
00290
Country
Finland
Facility Name
Pfizer Investigational Site
City
Tampere
ZIP/Postal Code
33520
Country
Finland
Facility Name
Pfizer Investigational Site
City
Besancon
ZIP/Postal Code
25030
Country
France
Facility Name
Pfizer Investigational Site
City
Bordeaux Cedex
ZIP/Postal Code
33076
Country
France
Facility Name
Pfizer Investigational Site
City
Clermont-Ferrand Cedex 1
ZIP/Postal Code
63011
Country
France
Facility Name
Pfizer Investigational Site
City
Lille
ZIP/Postal Code
59000
Country
France
Facility Name
Pfizer Investigational Site
City
Lyon
ZIP/Postal Code
69008
Country
France
Facility Name
Pfizer Investigational Site
City
Paris Cedex 15
ZIP/Postal Code
75908
Country
France
Facility Name
Pfizer Investigational Site
City
Poitiers cedex
ZIP/Postal Code
86021
Country
France
Facility Name
Pfizer Investigational Site
City
Rennes
ZIP/Postal Code
35042
Country
France
Facility Name
Pfizer Investigational Site
City
ROUEN Cedex
ZIP/Postal Code
76031
Country
France
Facility Name
Pfizer Investigational Site
City
Saint Gregoire
ZIP/Postal Code
35760
Country
France
Facility Name
Pfizer Investigational Site
City
Tours
ZIP/Postal Code
37044
Country
France
Facility Name
Pfizer Investigational Site
City
Berlin
ZIP/Postal Code
10719
Country
Germany
Facility Name
Pfizer Investigational Site
City
Homburg/Saar
ZIP/Postal Code
66421
Country
Germany
Facility Name
Pfizer Investigational Site
City
Kempen
ZIP/Postal Code
47906
Country
Germany
Facility Name
Pfizer Investigational Site
City
Leipzig
ZIP/Postal Code
04109
Country
Germany
Facility Name
Pfizer Investigational Site
City
Muenchen
ZIP/Postal Code
81675
Country
Germany
Facility Name
Pfizer Investigational Site
City
Muenster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Pfizer Investigational Site
City
Tuebingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Pfizer Investigational Site
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Facility Name
Pfizer Investigational Site
City
Kfar Saba
Country
Israel
Facility Name
Pfizer Investigational Site
City
Petach Tikva
ZIP/Postal Code
49100
Country
Israel
Facility Name
Pfizer Investigational Site
City
Tel Hashomer
ZIP/Postal Code
52621
Country
Israel
Facility Name
Pfizer Investigational Site
City
Zerifin
ZIP/Postal Code
70300
Country
Israel
Facility Name
Pfizer Investigational Site
City
Meldola
State/Province
FC
ZIP/Postal Code
47014
Country
Italy
Facility Name
Pfizer Investigational Site
City
Lido di Camaiore (LU)
ZIP/Postal Code
55043
Country
Italy
Facility Name
Pfizer Investigational Site
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Pfizer Investigational Site
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
Pfizer Investigational Site
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Pfizer Investigational Site
City
Pisa
ZIP/Postal Code
56100
Country
Italy
Facility Name
Pfizer Investigational Site
City
Potenza
ZIP/Postal Code
85100
Country
Italy
Facility Name
Pfizer Investigational Site
City
Roma
ZIP/Postal Code
00135
Country
Italy
Facility Name
Pfizer Investigational Site
City
Roma
ZIP/Postal Code
00152
Country
Italy
Facility Name
Pfizer Investigational Site
City
Goyang-si
State/Province
Gyeonggi-do
ZIP/Postal Code
410-769
Country
Korea, Republic of
Facility Name
Pfizer Investigational Site
City
Seongnam
State/Province
Gyunggido
ZIP/Postal Code
463-802
Country
Korea, Republic of
Facility Name
Pfizer Investigational Site
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Facility Name
Pfizer Investigational Site
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
Pfizer Investigational Site
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
Facility Name
Pfizer Investigational Site
City
Bellavista
State/Province
Callao
ZIP/Postal Code
Callao 02
Country
Peru
Facility Name
Pfizer Investigational Site
City
Arequipa
Country
Peru
Facility Name
Pfizer Investigational Site
City
Lima
ZIP/Postal Code
Lima 27
Country
Peru
Facility Name
Pfizer Investigational Site
City
Gdansk
ZIP/Postal Code
80-952
Country
Poland
Facility Name
Pfizer Investigational Site
City
Kielce
ZIP/Postal Code
25-734
Country
Poland
Facility Name
Pfizer Investigational Site
City
Warszawa
ZIP/Postal Code
02-507
Country
Poland
Facility Name
Pfizer Investigational Site
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Pfizer Investigational Site
City
Porto
ZIP/Postal Code
4200-072
Country
Portugal
Facility Name
Pfizer Investigational Site
City
Porto
ZIP/Postal Code
4200-319
Country
Portugal
Facility Name
Pfizer Investigational Site
City
Setúbal
ZIP/Postal Code
2910-446
Country
Portugal
Facility Name
Pfizer Investigational Site
City
Bratislava
ZIP/Postal Code
833 10
Country
Slovakia
Facility Name
Pfizer Investigational Site
City
Bratislava
ZIP/Postal Code
85105
Country
Slovakia
Facility Name
Pfizer Investigational Site
City
Martin
ZIP/Postal Code
036 01
Country
Slovakia
Facility Name
Pfizer Investigational Site
City
Prešov
ZIP/Postal Code
080 01
Country
Slovakia
Facility Name
Pfizer Investigational Site
City
Zilina
ZIP/Postal Code
012 07
Country
Slovakia
Facility Name
Pfizer Investigational Site
City
Elche
State/Province
Alicante
ZIP/Postal Code
03203
Country
Spain
Facility Name
Pfizer Investigational Site
City
L'hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Pfizer Investigational Site
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Facility Name
Pfizer Investigational Site
City
A Coruña
ZIP/Postal Code
15006
Country
Spain
Facility Name
Pfizer Investigational Site
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Pfizer Investigational Site
City
Gerona
ZIP/Postal Code
17007
Country
Spain
Facility Name
Pfizer Investigational Site
City
Guadalajara
ZIP/Postal Code
19002
Country
Spain
Facility Name
Pfizer Investigational Site
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Pfizer Investigational Site
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Pfizer Investigational Site
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Facility Name
Pfizer Investigational Site
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Pfizer Investigational Site
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Pfizer Investigational Site
City
Lund
ZIP/Postal Code
221 85
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Malmo
ZIP/Postal Code
205 02
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Stockholm
ZIP/Postal Code
171 76
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Vaxjo
ZIP/Postal Code
351 85
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Taichung
ZIP/Postal Code
407
Country
Taiwan
Facility Name
Pfizer Investigational Site
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Pfizer Investigational Site
City
Taipei
ZIP/Postal Code
112
Country
Taiwan
Facility Name
Pfizer Investigational Site
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
Facility Name
Pfizer Investigational Site
City
Bournemouth
State/Province
Dorset
ZIP/Postal Code
BH7 7DW
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Preston
State/Province
Lancashire
ZIP/Postal Code
PR2 9HT
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Northwood,
State/Province
Middlesex
ZIP/Postal Code
HA6 2RN
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Bristol
ZIP/Postal Code
BS2 8ED
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Cardiff
ZIP/Postal Code
CF14 2TL
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Glasgow
ZIP/Postal Code
G12 0YN
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Glasgow
ZIP/Postal Code
G52 3NQ
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Guildford
ZIP/Postal Code
GU2 7XX
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Sheffield
ZIP/Postal Code
S10 2SJ
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Swansea
ZIP/Postal Code
SA2 8QA
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
24323035
Citation
Michaelson MD, Oudard S, Ou YC, Sengelov L, Saad F, Houede N, Ostler P, Stenzl A, Daugaard G, Jones R, Laestadius F, Ullen A, Bahl A, Castellano D, Gschwend J, Maurina T, Chow Maneval E, Wang SL, Lechuga MJ, Paolini J, Chen I. Randomized, placebo-controlled, phase III trial of sunitinib plus prednisone versus prednisone alone in progressive, metastatic, castration-resistant prostate cancer. J Clin Oncol. 2014 Jan 10;32(2):76-82. doi: 10.1200/JCO.2012.48.5268. Epub 2013 Dec 9.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A6181120&StudyName=Sunitinib%20Plus%20Prednisone%20In%20Patients%20With%20Metastatic%20Castration-Resistant%20Prostate%20Cancer%20After%20Failure%20Of%20Docetaxel%20Chemotherapy
Description
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Learn more about this trial

Sunitinib Plus Prednisone In Patients With Metastatic Castration-Resistant Prostate Cancer After Failure Of Docetaxel Chemotherapy

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