PHA-739358 for Treatment of Hormone Refractory Prostate Cancer

Nerviano Medical Sciences

Status and phase: Completed; Phase 2

Conditions: Metastatic Hormone Refractory Prostate Cancer

Treatments: Drug: PHA-739358

Study type: Interventional

Funder types: Industry

Identifiers

NCT00766324

AURA-6202-007

Details and patient eligibility

About

To assess the antitumor activity of PHA-739358 administered as IV infusion according to two different dose schedules in metastatic HRPC patients progressing on standard, docetaxel-based 1st-line chemotherapy for HRPC based on PSA response, and to select the best dose schedule for further investigation.

Enrollment: 118 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Metastatic hormone refractory prostate cancer progressing after docetaxel based therapy
• Adequate bone marrow, liver and kidney function

Exclusion criteria

• More than one prior chemotherapy line
• Uncontrolled hypertension
• Brain or leptomeningeal disease
• Myocardial infarction, severe/unstable angina, symptomatic congestive heart failure, cerebrovascular accident in the previous 6 months

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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118 participants in 2 patient groups

A

Experimental group

Treatment:

Drug: PHA-739358

Drug: PHA-739358

B

Experimental group

Treatment:

Drug: PHA-739358

Drug: PHA-739358