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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

October 2, 2008
May 13, 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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
  • Overall safety profile [ Time Frame: all cycles ] [ Designated as safety issue: Yes ]
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00766324
AURA-6202-007
No
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