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A Safety and Efficacy Study of KX2-391 in Patients With Bone-Metastatic, Castration-Resistant Prostate Cancer Who Have Not Received Prior Chemotherapy

2014-08-27 03:15:42 | BioPortfolio

Summary

The standard of care for patients with bone-metastatic, castrate-resistant prostate cancer is chemotherapy. If a patient elects not to choose chemotherapy, 70% will progress within 6 months. KX2-391 given orally twice a day for 6 months will be evaluated for its ability to delay/prevent disease progression in patients who have not had prior chemotherapy.

Description

This is a multi-center, single-arm, open-label, prospective phase II clinical trial evaluating the efficacy, safety and pharmacokinetics of orally administered KX2-391 in adult male patients with progressive bone-metastatic CRPC. Patients must have 1) documented bone-metastatic prostate cancer, 2) castrate levels of testosterone, 3) not received prior chemotherapy, and 4) documented disease progression based on rising PSA, progressive measurable visceral disease and/or progressive bone lesions (one criteria is sufficient) as per the Prostate Cancer Clinical Trials Working Group (PCWG2) guidelines (Scher et al 2008).

Study Design

Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Bone-Metastatic, Castration-Resistant Prostate Cancer

Intervention

KX2-391

Location

University of Chicago
Chicago
Illinois
United States
60637

Status

Recruiting

Source

Kinex Pharmaceuticals, LLC

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:15:42-0400

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