A Phase I Study of BMS-641988 in Japanese Patients With Castration Resistant Prostate Cancer

Bristol-Myers Squibb7 enrolled

Overview

The purpose of this clinical study is to assess the safety and tolerability of BMS-641988 once daily orally in Japanese patients with castration resistant prostate cancer

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Prostate Cancer

Interventions

BMS-641988 (AR#2)DRUG

Tablets, Oral, 20 mg, 40 mg, 60 mg, 100 mg, once daily, 24 weeks

Eligibility

Sex: MALEMin age: 20 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with castration-resistant prostate cancer and serum testosterone ≤50 ng/dL progressive to current therapy who satisfy the inclusion and exclusion criteria

Locations (3)

Local Institution

Hidaka, Saitama, Japan

Local Institution

Hamamatsu, Shizuoka, Japan

Local Institution

Koto-Ku, Tokyo, Japan

Outcomes

Primary Outcomes

To assess the safety and tolerability of BMS-641988 once daily orally in Japanese patients with castration resistant prostate cancer

Time frame: throughout the study

Secondary Outcomes

To evaluate the pharmacokinetics of BMS-641988 and the metabolites BMS-501949 and BMS-570511

Time frame: at cycle 1 day 1, day 15 and day 29

To identify the dose(s) of BMS-641988 for Phase II

Time frame: at the end of study

To assess any preliminary evidence of anti-tumor activity by PSA decline, tumor shrinkage, radionuclide bone scans

Time frame: throughout the study

To assess the effects of BMS-641988 on pharmacodynamic markers (LH, total and free testosterone, 5(alpha)-DHT, estradiol, prolactin, FSH, and SHBG)

Time frame: throughout the study

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.