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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00676650




Registration number
NCT00676650
Ethics application status
Date submitted
8/05/2008
Date registered
13/05/2008
Date last updated
8/03/2013

Titles & IDs
Public title
Sunitinib Plus Prednisone In Patients With Metastatic Castration-Resistant Prostate Cancer After Failure Of Docetaxel Chemotherapy
Scientific 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
Secondary ID [1] 0 0
A6181120
Universal Trial Number (UTN)
Trial acronym
SUN 1120
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostatic Neoplasms 0 0
Condition category
Condition code
Cancer 0 0 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Prednisone
Treatment: Drugs - sunitinib
Treatment: Drugs - Placebo
Treatment: Drugs - Prednisone

Experimental: A - Treatment Arm A - sunitinib + prednisone

Placebo comparator: B - Treatment Arm B - placebo + prednisone


Treatment: Drugs: Prednisone
5 mg BID, oral

Treatment: Drugs: sunitinib
37.5 mg/day, oral, administered on a continuous daily dosing regimen

Treatment: Drugs: Placebo
37.5 mg/day, oral, administered on a continuous daily dosing regimen

Treatment: Drugs: Prednisone
5 mg BID, oral
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
Baseline up to 32 months
Secondary outcome [1] 0 0
Progression-Free Survival (PFS)
Timepoint [1] 0 0
Baseline, every 8 weeks up to 123 weeks
Secondary outcome [2] 0 0
Percent of Participants With Objective Response (OR)
Timepoint [2] 0 0
Baseline, every 8 weeks up to 123 weeks
Secondary outcome [3] 0 0
Duration of Response (DR)
Timepoint [3] 0 0
Baseline, every 8 weeks up to 123 weeks
Secondary outcome [4] 0 0
Change From Baseline in Pain Severity
Timepoint [4] 0 0
Day 1 through Day 7 every 28 days (every cycle) up to 29 months
Secondary outcome [5] 0 0
Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P)
Timepoint [5] 0 0
Baseline, every 4 weeks up to 123 weeks
Secondary outcome [6] 0 0
Change From Baseline in Euro Quality of Life (EQ-5D)- Health State Profile Utility Score
Timepoint [6] 0 0
Baseline, every 4 weeks up to 123 weeks

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2011
Sample size
Target
Accrual to date
Final
873
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Pfizer Investigational Site - Port Macquarie
Recruitment hospital [2] 0 0
Pfizer Investigational Site - Wahroong
Recruitment hospital [3] 0 0
Pfizer Investigational Site - Westmead
Recruitment hospital [4] 0 0
Pfizer Investigational Site - Wodonga
Recruitment postcode(s) [1] 0 0
2444 - Port Macquarie
Recruitment postcode(s) [2] 0 0
2076 - Wahroong
Recruitment postcode(s) [3] 0 0
2145 - Westmead
Recruitment postcode(s) [4] 0 0
3690 - Wodonga
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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United States of America
State/province [2] 0 0
California
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United States of America
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Colorado
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Florida
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Illinois
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Indiana
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Kentucky
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Maryland
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Massachusetts
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Minnesota
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Mississippi
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Nebraska
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Nevada
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New Jersey
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New York
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North Carolina
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North Dakota
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Ohio
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Oregon
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Tennessee
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Texas
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Washington
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Wisconsin
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Bruxelles
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Wilrijk
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Herlev
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Odense C
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Sheffield
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Swansea

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00676650