PHA-739358 for Treatment of Hormone Refractory Prostate Cancer - Full Text View

Sponsor:	Nerviano Medical Sciences
Information provided by:	Nerviano Medical Sciences
ClinicalTrials.gov Identifier:	NCT00766324

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 II

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:

MedlinePlus related topics: Cancer Prostate Cancer

U.S. FDA Resources

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 ]

Estimated 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

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:	Clinical Development, 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 16, 2011
Health Authority:	United States: Food and Drug Administration; United States: Institutional Review Board; France: Afssaps - French Health Products Safety Agency; 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 February 09, 2012