drugset

drugset / Trial / NCT01995513

Safety Study of Continued Enzalutamide Treatment In Prostate Cancer Patients

NCT01995513 ↗

Phase 4 Completed 509 enrolled Pfizer Astellas Pharma Inc · collab Medivation LLC, a wholly owned subsidiary of Pfizer Inc. · collab

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to determine if continued treatment with Enzalutamide is effective in patients with metastatic prostate cancer.

Timeline

Start: 2013-10-22
Primary completion: 2016-11-15
Completion: 2022-08-31

Publications

Attard G, Borre M, Gurney H, Loriot Y, Andresen-Daniil C, Kalleda R, Pham T, Taplin ME; PLATO collaborators. Abiraterone Alone or in Combination With Enzalutamide in Metastatic Castration-Resistant Prostate Cancer With Rising Prostate-Specific Antigen During Enzalutamide Treatment. J Clin Oncol. 2018 Sep 1;36(25):2639-2646. doi: 10.1200/JCO.2018.77.9827. Epub 2018 Jul 20.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Enzalutamide	Other / unclassified	160 mg	Oral
Background	Abiraterone acetate	Small molecule	1000 mg	Oral
Background	Prednisone	Other / unclassified	5 mg	Oral

Indications