A Randomized Phase 3 Study Comparing Standard First-Line Docetaxel/Prednisone to Docetaxel/Prednisone in Combination With Custirsen (OGX-011) in Men With Metastatic Castrate Resistant Prostate Cancer
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Achieve Life Sciences
- Enrollment
- 1,022
- Locations
- 140
- Primary Endpoint
- Kaplan-Meier Estimates for Time to Death (Overall Survival)
Study Overview
Brief Summary
This Phase 3 study has been designed to confirm that adding custirsen to standard first-line docetaxel/prednisone treatment can slow tumor progression and enhance survival outcomes compared to standard first-line docetaxel/prednisone treatment alone. This will be a randomized, open-label, multicenter, international trial. Treatment will consist of docetaxel/prednisone/custirsen vs. docetaxel/prednisone. A total of at least 1000 patients will be randomized. Patients will be randomly assigned with equal probability to the two arms.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Custirsen, Docetaxel, Prednisone
Three doses of 640 mg custirsen administered intravenously (IV) as a loading dose between Days -9 to -1. Custirsen, 640 mg, given IV weekly on Days 1, 8, and 15 of each 21-day cycle. Docetaxel (75 mg/M^2 via intravenous injection) on Day 1 of every 21 days plus prednisone (5 mg tablets taken by mouth) twice each day and dexamethasone (8 mg by mouth twice a day for 3 days beginning one day before docetaxel administration).
Treatment continues for 10 cycles or until unacceptable toxicity or disease progression.
Intervention: Custirsen (Drug)
Custirsen, Docetaxel, Prednisone
Three doses of 640 mg custirsen administered intravenously (IV) as a loading dose between Days -9 to -1. Custirsen, 640 mg, given IV weekly on Days 1, 8, and 15 of each 21-day cycle. Docetaxel (75 mg/M^2 via intravenous injection) on Day 1 of every 21 days plus prednisone (5 mg tablets taken by mouth) twice each day and dexamethasone (8 mg by mouth twice a day for 3 days beginning one day before docetaxel administration).
Treatment continues for 10 cycles or until unacceptable toxicity or disease progression.
Intervention: Docetaxel (Drug)
Custirsen, Docetaxel, Prednisone
Three doses of 640 mg custirsen administered intravenously (IV) as a loading dose between Days -9 to -1. Custirsen, 640 mg, given IV weekly on Days 1, 8, and 15 of each 21-day cycle. Docetaxel (75 mg/M^2 via intravenous injection) on Day 1 of every 21 days plus prednisone (5 mg tablets taken by mouth) twice each day and dexamethasone (8 mg by mouth twice a day for 3 days beginning one day before docetaxel administration).
Treatment continues for 10 cycles or until unacceptable toxicity or disease progression.
Intervention: Prednisone (Drug)
Custirsen, Docetaxel, Prednisone
Three doses of 640 mg custirsen administered intravenously (IV) as a loading dose between Days -9 to -1. Custirsen, 640 mg, given IV weekly on Days 1, 8, and 15 of each 21-day cycle. Docetaxel (75 mg/M^2 via intravenous injection) on Day 1 of every 21 days plus prednisone (5 mg tablets taken by mouth) twice each day and dexamethasone (8 mg by mouth twice a day for 3 days beginning one day before docetaxel administration).
Treatment continues for 10 cycles or until unacceptable toxicity or disease progression.
Intervention: Dexamethasone (Drug)
Docetaxel, Prednisone
Docetaxel (75 mg/M^2 via intravenous injection) on Day 1 of every 21 days plus prednisone (5 mg tablets taken by mouth) twice each day and dexamethasone (8 mg by mouth twice a day for 3 days beginning one day before docetaxel administration).
Treatment continues for 10 cycles or until unacceptable toxicity or disease progression.
Intervention: Docetaxel (Drug)
Docetaxel, Prednisone
Docetaxel (75 mg/M^2 via intravenous injection) on Day 1 of every 21 days plus prednisone (5 mg tablets taken by mouth) twice each day and dexamethasone (8 mg by mouth twice a day for 3 days beginning one day before docetaxel administration).
Treatment continues for 10 cycles or until unacceptable toxicity or disease progression.
Intervention: Prednisone (Drug)
Docetaxel, Prednisone
Docetaxel (75 mg/M^2 via intravenous injection) on Day 1 of every 21 days plus prednisone (5 mg tablets taken by mouth) twice each day and dexamethasone (8 mg by mouth twice a day for 3 days beginning one day before docetaxel administration).
Treatment continues for 10 cycles or until unacceptable toxicity or disease progression.
Intervention: Dexamethasone (Drug)
Outcomes
Primary Outcomes
Kaplan-Meier Estimates for Time to Death (Overall Survival)
Time Frame: Randomization (approximately Day -12) to longest survival follow-up (Day 971).
Time from the date of randomization to death from any cause. After stopping treatment, patients were followed every 4 weeks until disease progression and then followed every 12 weeks until death.
Secondary Outcomes
- Percentage of Participants with Adverse Events(Docetaxel/prednisone/custirsen arm: Days -9 up to Day 743. Docetaxel/prednisone arm: Day 1 up to Day 400.)
- Percentage of Participants Who Were Alive Without Event At Day 140(Day 125-155)