PHA-739358 for Treatment of Hormone Refractory Prostate Cancer

Metastatic Hormone Refractory Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00766324
• Other study ID #: AURA-6202-007
• Status: Completed
• Phase: Phase 2
• First received: October 2, 2008
• Last updated: May 13, 2014
• Start date: September 2007
• Est. completion date: April 2011

Study information

• Verified date: May 2014
• Source: Nerviano Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review BoardFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: Institutional Ethical CommitteeItaly: Ethics CommitteeNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: April 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Metastatic Hormone Refractory Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• PHA-739358
6-hr IV infusion weekly for 3 consecutive weeks in a 4-week cycle
• PHA-739358
24-hr IV infusion every 2 weeks in a 4-week cycle

Locations

Country	Name	City	State
Italy	Nerviano Medical Sciences. Clinical Research Dept.	Nerviano	Milano

Sponsors (1)

Lead Sponsor	Collaborator
Nerviano Medical Sciences

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PSA response rate defined according to the recommendations from the Prostate-Specific Antigen Working Group		within the first three months of treatment	No
Secondary	Objective Response Rate, Progression Free Survival, additional PSA based endpoints, clinical benefit		all cycles	No
Secondary	Overall safety profile		all cycles	Yes