drugset

drugset / Trial / NCT01284920

A Study of MDV3100 to Evaluate Safety, Tolerability, Pharmacokinetics and Efficacy of in Prostate Cancer Patients

NCT01284920 ↗

Phase 1/2 Completed 47 enrolled Astellas Pharma Inc Medivation LLC, a wholly owned subsidiary of Pfizer Inc. · collab

Non-randomizedSingle-groupOpen-labelTreatment

Summary

This study is to evaluate safety, tolerability pharmacokinetics and efficacy of MDV3100 after oral administration to patients with castration-resistant prostate cancer.

Timeline

Start: 2010-11-02
Primary completion: 2012-07-12
Completion: 2014-07-02

Publications

Akaza H, Uemura H, Tsukamoto T, Ozono S, Ogawa O, Sakai H, Oya M, Namiki M, Fukasawa S, Yamaguchi A, Uemura H, Ohashi Y, Maeda H, Saito A, Takeda K, Naito S. A multicenter phase I/II study of enzalutamide in Japanese patients with castration-resistant prostate cancer. Int J Clin Oncol. 2016 Aug;21(4):773-782. doi: 10.1007/s10147-016-0952-6. Epub 2016 Jan 21.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Enzalutamide	Other / unclassified	80 mg	Oral
Subject	Enzalutamide	Other / unclassified	160 mg	Oral
Subject	Enzalutamide	Other / unclassified	240 mg	Oral

Indications