PHA-739358 for Treatment of Hormone Refractory Prostate Cancer - Tabular View

Tracking Information

First Received Date ^ICMJE

October 2, 2008

Last Updated Date

October 2, 2008

Start Date ^ICMJE

September 2007

Estimated Primary Completion Date

February 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

PSA response rate defined according to the recommendations from the Prostate-Specific Antigen Working Group [ Time Frame: within the first three months of treatment ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Objective Response Rate, Progression Free Survival, additional PSA based endpoints, clinical benefit [ Time Frame: all cycles ] [ Designated as safety issue: No ]
Overall safety profile [ Time Frame: all cycles ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

PHA-739358 for Treatment of Hormone Refractory Prostate Cancer

Official Title ^ICMJE

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

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

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Metastatic Hormone Refractory Prostate Cancer

Intervention ^ICMJE

Drug: PHA-739358

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

118

Completion Date

Estimated Primary Completion Date

February 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Male

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Maria Gabriella Jannuzzo, PhD

+390331581475

mariagabriella.jannuzzo@nervianoms.com

Location Countries ^ICMJE

Italy

Administrative Information

NCT ID ^ICMJE

NCT00766324

Responsible Party

Clinical Research , Head, Nerviano Medical Sciences

Study ID Numbers ^ICMJE

AURA-6202-007

Study Sponsor ^ICMJE

Nerviano Medical Sciences

Collaborators ^ICMJE

Investigators ^ICMJE

Information Provided By

Nerviano Medical Sciences

Verification Date

October 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP