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Trial of IV Injection of CV787 in Hormone Refractory Metastatic Prostate Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00116155
First Posted: June 28, 2005
Last Update Posted: June 28, 2005
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:
Cell Genesys
  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 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
  Contacts and Locations
No Contacts or Locations Provided
  More Information

ClinicalTrials.gov Identifier: NCT00116155     History of Changes
Other Study ID Numbers: CV787-9902
First Submitted: June 27, 2005
First Posted: June 28, 2005
Last Update Posted: June 28, 2005
Last Verified: June 2005

Keywords provided by Cell Genesys:
Hormone Refractory Metastatic Prostate Cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs