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

June 27, 2005
June 27, 2005
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To determine the safety, tolerability, and the maximum tolerated dose of CG7870 when administered intravenously to patients with progressive metastatic hormone refractory prostate cancer
Same as current
No Changes Posted
  • 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
Same as current
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Trial of IV Injection of CV787 in Hormone Refractory Metastatic Prostate Cancer
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

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.

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Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Prostate Cancer
Biological: CV787 (CG7870)
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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Contact information is only displayed when the study is recruiting subjects
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NCT00116155
CV787-9902
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Cell Genesys
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Cell Genesys
June 2005

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