PHA-739358 for Treatment of Hormone Refractory Prostate Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nerviano Medical Sciences
ClinicalTrials.gov Identifier:
NCT00766324
First received: October 2, 2008
Last updated: May 13, 2014
Last verified: May 2014
  Purpose

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 Intervention Phase
Metastatic Hormone Refractory Prostate Cancer
Drug: PHA-739358
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of PHA-739358 in Patients With Metastatic Hormone Refractory Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Nerviano Medical Sciences:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 118
Study Start Date: September 2007
Study Completion Date: April 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00766324

Locations
Italy
Nerviano Medical Sciences. Clinical Research Dept.
Nerviano, Milano, Italy, 20014
Sponsors and Collaborators
Nerviano Medical Sciences
  More Information

No publications provided

Responsible Party: Nerviano Medical Sciences
ClinicalTrials.gov Identifier: NCT00766324     History of Changes
Other Study ID Numbers: AURA-6202-007
Study First Received: October 2, 2008
Last Updated: May 13, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Institutional Ethical Committee
Italy: Ethics Committee
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Netherlands: Medical Ethics Review Committee (METC)

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 23, 2014