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Trial of IV Injection of CV787 in Hormone Refractory Metastatic Prostate Cancer
This study has been completed.
Sponsored by: Cell Genesys
Information provided by: Cell Genesys
ClinicalTrials.gov Identifier: NCT00116155
  Purpose

This is a multi-center, open-label, dose finding study of CV787 adenovirus in patients with hormone refractory metastatic prostate cancer. Patients will receive treatment intravenously at one of up to nine dose levels, each containing three to six patients.


Condition Intervention Phase
Prostate Cancer
 Biological: CV787 (CG7870)
 Phase I
Phase II

MedlinePlus related topics: Cancer Prostate Cancer
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: A Phase I/II Dose Finding Trial of the Intravenous Injection of CV787, a Prostate-Specific Antigen Cytolytic Adenovirus, in Patients With Hormone Refractory Metastatic Prostate Cancer

Further study details as provided by Cell Genesys:

Primary Outcome Measures:
  • To determine the safety, tolerability, and the maximum tolerated dose of CG7870 when administered intravenously to patients with progressive metastatic hormone refractory prostate cancer

Secondary Outcome Measures:
  • To evaluate prostate-specific antigen (PSA) response rates, duration of response, and time to disease progression
  • To evaluate other clinical efficacy responses observed
  • To evaluate the systemic pharmacokinetics of CG7870 after intravenous administration
  • To monitor the immune response to CG7870

  Eligibility

  Contacts and Locations
No Contacts or Locations Provided
  More Information

Study ID Numbers: CV787-9902
Study First Received: June 27, 2005
Last Updated: June 27, 2005
ClinicalTrials.gov Identifier: NCT00116155  
Health Authority: United States: Food and Drug Administration

Keywords provided by Cell Genesys:
Hormone Refractory Metastatic Prostate Cancer

Study placed in the following topic categories:
Signs and Symptoms
Prostatic Diseases
Genital Neoplasms, Male
Adenoviridae Infections
 Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 14, 2009



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