PHA-739358 for Treatment of Hormone Refractory Prostate Cancer
Phase 2
Completed
- Conditions
- Metastatic Hormone Refractory Prostate Cancer
- Interventions
- Registration Number
- NCT00766324
- Lead Sponsor
- Nerviano Medical Sciences
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 118
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A PHA-739358 - B PHA-739358 -
- Primary Outcome Measures
Name Time Method PSA response rate defined according to the recommendations from the Prostate-Specific Antigen Working Group within the first three months of treatment
- Secondary Outcome Measures
Name Time Method Objective Response Rate, Progression Free Survival, additional PSA based endpoints, clinical benefit all cycles Overall safety profile all cycles
Trial Locations
- Locations (1)
Nerviano Medical Sciences. Clinical Research Dept.
🇮🇹Nerviano, Milano, Italy