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

This study has been completed.
Sponsor:
Information provided by:
Cell Genesys
ClinicalTrials.gov Identifier:
NCT00116155
First received: June 27, 2005
Last updated: NA
Last verified: June 2005
History: No changes posted
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

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

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
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 14, 2014