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drugset / Trial / NCT02480010

A Study of Pertuzumab in Participants With Prostate Cancer

NCT02480010 ↗

Phase 2 Terminated 68 enrolled Hoffmann-La Roche
Non-randomizedParallel-groupOpen-labelTreatment

Summary

This study will evaluate the efficacy and safety of intravenous (IV) pertuzumab in participants with hormone-refractory prostate cancer who have had no previous chemotherapy. Participants will be enrolled in two stages, the first (Cohort A) at a lower 420-mg dose and the second (Cohort B) at a higher 1050-mg dose based upon observations in Cohort A. Up to 50 participants may enter either cohort, for a total enrollment between 46 and 73 participants across 9 study centers.

Timeline

Start
2003-09
Primary completion
2005-09
Completion
2005-09

Outcome

Outcome not reported

Stopped: “The study was terminated at the time of interim analysis since none of the participants showed a PSA response.”

Drugs

EvaluationDrugModalityDoseRoute
Subject Pertuzumab Monoclonal antibody 420 mg Intravenous
Subject Pertuzumab Monoclonal antibody 1050 mg Intravenous

Indications

prostate cancer