Sunitinib Plus Prednisone In Patients With Metastatic Castration-Resistant Prostate Cancer After Failure Of Docetaxel Chemotherapy (SUN 1120)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|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|
- Overall Survival (OS) [ Time Frame: Baseline up to 32 months ] [ Designated as safety issue: No ]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.
- Progression-Free Survival (PFS) [ Time Frame: Baseline, every 8 weeks up to 123 weeks ] [ Designated as safety issue: No ]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) [ Time Frame: Baseline, every 8 weeks up to 123 weeks ] [ Designated as safety issue: No ]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 Frame: Baseline, every 8 weeks up to 123 weeks ] [ Designated as safety issue: No ]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 [ Time Frame: Day 1 through Day 7 every 28 days (every cycle) up to 29 months ] [ Designated as safety issue: No ]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) [ Time Frame: Baseline, every 4 weeks up to 123 weeks ] [ Designated as safety issue: No ]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 [ Time Frame: Baseline, every 4 weeks up to 123 weeks ] [ Designated as safety issue: No ]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.
|Study Start Date:||July 2008|
|Study Completion Date:||December 2011|
|Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
Treatment Arm A - sunitinib + prednisone
5 mg BID, oral
Other Name: DeltasoneDrug: sunitinib
37.5 mg/day, oral, administered on a continuous daily dosing regimen
Other Name: Sutent, SU011248
Placebo Comparator: B
Treatment Arm B - placebo + prednisone
37.5 mg/day, oral, administered on a continuous daily dosing regimenDrug: Prednisone
5 mg BID, oral
Other Name: Deltasone
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|Study Director:||Pfizer CT.gov Call Center||Pfizer|