Back to resultsTrial of IV Injection of CV787 in Hormone Refractory Metastatic Prostate Cancer
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
CV787 (CG7870)
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring Hormone Refractory Metastatic Prostate Cancer
Eligibility Criteria
Sites / Locations
Outcomes
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00116155
Brief Title
Trial of IV Injection of CV787 in Hormone Refractory Metastatic Prostate Cancer
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2005
Overall Recruitment Status
Completed
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators
Name of the Sponsor
Cell Genesys
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Hormone Refractory Metastatic Prostate Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
CV787 (CG7870)
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
To evaluate prostate-specific antigen (PSA) response rates, duration of response, and time to disease progression
Title
To evaluate other clinical efficacy responses observed
Title
To evaluate the systemic pharmacokinetics of CG7870 after intravenous administration
Title
To monitor the immune response to CG7870
10. Eligibility
12. IPD Sharing Statement
Learn more about this trial
Trial of IV Injection of CV787 in Hormone Refractory Metastatic Prostate Cancer
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