PHA-739358 for Treatment of Hormone Refractory Prostate Cancer

Sponsor

Nerviano Medical Sciences (Industry)

Overall Status

Completed

CT.gov ID

NCT00766324

Collaborator

(none)

118

Enrollment

Location

Arms

Duration (Months)

2.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Metastatic Hormone Refractory Prostate Cancer	Drug: PHA-739358 Drug: PHA-739358	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

118 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase II Study of PHA-739358 in Patients With Metastatic Hormone Refractory Prostate Cancer

Study Start Date :

Sep 1, 2007

Actual Primary Completion Date :

Mar 1, 2011

Actual Study Completion Date :

Apr 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: A	Drug: PHA-739358 6-hr IV infusion weekly for 3 consecutive weeks in a 4-week cycle
Experimental: B	Drug: PHA-739358 24-hr IV infusion every 2 weeks in a 4-week cycle

Arm

Intervention/Treatment

Experimental: A

Drug: PHA-739358

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

Experimental: B

Drug: PHA-739358

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

Outcome Measures

Primary Outcome Measures

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

Objective Response Rate, Progression Free Survival, additional PSA based endpoints, clinical benefit [all cycles]
Overall safety profile [all cycles]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Nerviano Medical Sciences. Clinical Research Dept.	Nerviano	Milano	Italy	20014

Sponsors and Collaborators

Nerviano Medical Sciences

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Nerviano Medical Sciences

ClinicalTrials.gov Identifier:

NCT00766324

Other Study ID Numbers:

AURA-6202-007

First Posted:

Oct 3, 2008

Last Update Posted:

May 28, 2014

Last Verified:

May 1, 2014

Additional relevant MeSH terms:

Prostatic Neoplasms

Study Results

No Results Posted as of May 28, 2014