drugset / Trial / NCT01487863

Concurrent vs. Sequential Sipuleucel-T & Abiraterone Treatment in Men With Metastatic Castrate Resistant Prostate Cancer

NCT01487863

Phase 2 Completed 69 enrolled Dendreon
RandomizedParallel-groupOpen-labelBasic science

Summary

The purpose of this study was to evaluate the impact of concurrent versus sequential administration of abiraterone acetate plus prednisone on the ability to manufacture sipuleucel-T (by assessing sipuleucel-T product parameters), and to assess the safety and efficacy of sipuleucel-T with concurrent or sequential administration of abiraterone acetate plus prednisone in men with metastatic castrate resistant prostate cancer.

Timeline

Start
2011-12
Primary completion
2016-05
Completion
2016-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Abiraterone acetate Small molecule 1000 mg Oral
Subject Sipuleucel-T Cell therapy Intravenous
Background Prednisone Other / unclassified 5 mg Oral