PHA-739358 for Treatment of Hormone Refractory Prostate Cancer

May 13, 2014 updated by: Nerviano Medical Sciences

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

118

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Milano
      • Nerviano, Milano, Italy, 20014
        • Nerviano Medical Sciences. Clinical Research Dept.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
PSA response rate defined according to the recommendations from the Prostate-Specific Antigen Working Group
Time Frame: within the first three months of treatment
within the first three months of treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Objective Response Rate, Progression Free Survival, additional PSA based endpoints, clinical benefit
Time Frame: all cycles
all cycles
Overall safety profile
Time Frame: all cycles
all cycles

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nerviano Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

April 1, 2011

Study Registration Dates

First Submitted

October 2, 2008

First Submitted That Met QC Criteria

October 2, 2008

First Posted (Estimate)

October 3, 2008

Study Record Updates

Last Update Posted (Estimate)

May 28, 2014

Last Update Submitted That Met QC Criteria

May 13, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AURA-6202-007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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