PHA-739358 for Treatment of Hormone Refractory Prostate Cancer

Nerviano Medical Sciences118 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

118

Conditions

Metastatic Hormone Refractory Prostate Cancer

Interventions

PHA-739358DRUG

6-hr IV infusion weekly for 3 consecutive weeks in a 4-week cycle

PHA-739358DRUG

24-hr IV infusion every 2 weeks in a 4-week cycle

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Nerviano Medical Sciences. Clinical Research Dept.

Nerviano, Milano, Italy

Outcomes

Primary Outcomes

PSA response rate defined according to the recommendations from the Prostate-Specific Antigen Working Group

Time frame: within the first three months of treatment

Secondary Outcomes

Objective Response Rate, Progression Free Survival, additional PSA based endpoints, clinical benefit

Time frame: all cycles

Overall safety profile

Time frame: all cycles

Data from ClinicalTrials.gov

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