A multicenter phase I/II study of enzalutamide in Japanese patients with castration-resistant prostate cancer.

ABSTRACT:

Background

The safety, tolerability, pharmacokinetics (PK) and anti-tumor activity of enzalutamide were investigated in patients with castration-resistant prostate cancer (CRPC) in Japan through a multicenter phase I/II study.

Methods

In phase I, patients with progressive metastatic CRPC received single, then multiple, ascending doses of enzalutamide 80, 160 or 240 mg/day. After assessment of tolerability at multiple doses of 160 mg/day for 4 weeks, post-docetaxel patients with CRPC and measurable disease were enrolled into phase II; receiving long-term administration of enzalutamide 160 mg/day.

Results

Nine and 38 patients were enrolled in phase I and II, respectively. During phase I, enzalutamide was well tolerated in each cohort; PK parameters were similar to those

SUBMITTER: Akaza H 

PROVIDER: S-EPMC4967591 | biostudies-literature | 2016 Aug

REPOSITORIES: biostudies-literature