Metastatic Hormone Refractory Prostate Cancer
Conditions
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.
Interventions
DRUGPHA-739358
6-hr IV infusion weekly for 3 consecutive weeks in a 4-week cycle
Sponsors
Nerviano Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PSA response rate defined according to the recommendations from the Prostate-Specific Antigen Working Group | within the first three months of treatment |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate, Progression Free Survival, additional PSA based endpoints, clinical benefit | all cycles |
| Overall safety profile | all cycles |
Countries
Italy
Outcome results
None listed