drugset / Trial / NCT00075192

CP-675,206 With Neoadjuvant Hormone Therapy in Patients With High Risk Prostate Cancer

NCT00075192

Phase 1/2 Completed 8 enrolled AstraZeneca
RandomizedParallel-groupOpen-labelTreatment

Summary

This is a multi-center, open label, randomized study. Patients will be randomized to one of the following arms with an allocation ratio of 3:1, respectively: Arm A: CP-675,206 + neoadjuvant hormone therapy (NHT) OR Arm B: neoadjuvant hormone therapy. After randomization, patients will receive study treatment for three cycles (one cycle is defined as 28 days). After completion of three cycles, patients will undergo a prostatectomy and pathology assessments will be completed at a central laboratory, the Armed Forces Institute of Pathology (AFIP) in Washington, DC.

Timeline

Start
2004-03
Primary completion
Completion
2006-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Tremelimumab Monoclonal antibody
Background Bicalutamide Other / unclassified
Background Leuprolide Other / unclassified

Indications