Back to resultsPHA-739358 for Treatment of Hormone Refractory Prostate Cancer
Primary Purpose
Metastatic Hormone Refractory Prostate Cancer
Status
Completed
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
PHA-739358
PHA-739358
Sponsored by
About this trial
This is an interventional treatment trial for Metastatic Hormone Refractory Prostate Cancer
Eligibility Criteria
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
Sites / Locations
- Nerviano Medical Sciences. Clinical Research Dept.
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
A
B
Arm Description
Outcomes
Primary Outcome Measures
PSA response rate defined according to the recommendations from the Prostate-Specific Antigen Working Group
Secondary Outcome Measures
Objective Response Rate, Progression Free Survival, additional PSA based endpoints, clinical benefit
Overall safety profile
Full Information
NCT ID
NCT00766324
First Posted
October 2, 2008
Last Updated
May 13, 2014
Sponsor
Nerviano Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT00766324
Brief Title
PHA-739358 for Treatment of Hormone Refractory Prostate Cancer
Official Title
A Phase II Study of PHA-739358 in Patients With Metastatic Hormone Refractory Prostate Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
April 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nerviano Medical Sciences
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Hormone Refractory Prostate Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
118 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Title
B
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
PHA-739358
Intervention Description
6-hr IV infusion weekly for 3 consecutive weeks in a 4-week cycle
Intervention Type
Drug
Intervention Name(s)
PHA-739358
Intervention Description
24-hr IV infusion every 2 weeks in a 4-week cycle
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Objective Response Rate, Progression Free Survival, additional PSA based endpoints, clinical benefit
Time Frame
all cycles
Title
Overall safety profile
Time Frame
all cycles
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Nerviano Medical Sciences. Clinical Research Dept.
City
Nerviano
State/Province
Milano
ZIP/Postal Code
20014
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
PHA-739358 for Treatment of Hormone Refractory Prostate Cancer
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