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

Sponsored by:	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

MedlinePlus related topics: Cancer Prostate Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase II Study of PHA-739358 in Patients With Metastatic Hormone Refractory Prostate Cancer

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
Estimated Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	Drug: PHA-739358 6-hr IV infusion weekly for 3 consecutive weeks in a 4-week cycle
B: Experimental	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

Contacts

Contact: Maria Gabriella Jannuzzo, PhD

+390331581475

mariagabriella.jannuzzo@nervianoms.com

Locations

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

Sponsors and Collaborators

Nerviano Medical Sciences

More Information

Responsible Party:	Nerviano Medical Sciences ( Clinical Research , Head )
Study ID Numbers:	AURA-6202-007
Study First Received:	October 2, 2008
Last Updated:	October 2, 2008
ClinicalTrials.gov Identifier:	NCT00766324
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)

Study placed in the following topic categories:

Prostatic Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009