Prostate Cancer Clinical Trial
Official title:
A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study of Tasquinimod in Men With Metastatic Castrate Resistant Prostate Cancer
This is a Phase 3 randomized, double blind, placebo controlled study of tasquinimod in
asymptomatic to mildly symptomatic patients with metastatic CRPC to confirm the effect of
tasquinimod on delaying disease progression compared with placebo.
Approximately 1200 eligible patients with metastatic CRPC will be randomly assigned in a 2:1
ratio to 1 of 2 treatment groups: Treatment Group A (tasquinimod 0.25, 0.5, or 1 mg/day;
n=800) or Treatment Group B (placebo; n=400).
This is a Phase 3 randomized, double blind, placebo controlled study of tasquinimod in
asymptomatic to mildly symptomatic patients with metastatic CRPC to confirm the effect of
tasquinimod on delaying disease progression compared with placebo.
Approximately 1200 eligible patients with metastatic CRPC will be randomly assigned in a 2:1
ratio to 1 of 2 treatment groups: Treatment Group A (tasquinimod 0.25, 0.5, or 1 mg/day;
n=800) or Treatment Group B (placebo; n=400).
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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