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PHA-739358 for Treatment of Hormone Refractory Prostate Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00766324
First Posted: October 3, 2008
Last Update Posted: May 28, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Nerviano Medical Sciences
October 2, 2008
October 3, 2008
May 28, 2014
September 2007
March 2011   (Final data collection date for primary outcome measure)
PSA response rate defined according to the recommendations from the Prostate-Specific Antigen Working Group [ Time Frame: within the first three months of treatment ]
Same as current
Complete list of historical versions of study NCT00766324 on ClinicalTrials.gov Archive Site
  • Objective Response Rate, Progression Free Survival, additional PSA based endpoints, clinical benefit [ Time Frame: all cycles ]
  • Overall safety profile [ Time Frame: all cycles ]
Same as current
Not Provided
Not Provided
 
PHA-739358 for Treatment of Hormone Refractory Prostate Cancer
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Metastatic Hormone Refractory Prostate Cancer
  • 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: A
    Intervention: Drug: PHA-739358
  • Experimental: B
    Intervention: Drug: PHA-739358
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
118
April 2011
March 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Male
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
 
NCT00766324
AURA-6202-007
No
Not Provided
Not Provided
Nerviano Medical Sciences
Nerviano Medical Sciences
Not Provided
Not Provided
Nerviano Medical Sciences
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP