Trial of IV Injection of CV787 in Hormone Refractory Metastatic Prostate Cancer
June 27, 2005 updated by: Cell Genesys
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.
Study Overview
Study Type
Interventional
Phase
- Phase 2
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
N/A
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
|---|
|
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
Outcome Measure |
|---|
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
June 27, 2005
First Submitted That Met QC Criteria
June 27, 2005
First Posted (Estimate)
June 28, 2005
Study Record Updates
Last Update Posted (Estimate)
June 28, 2005
Last Update Submitted That Met QC Criteria
June 27, 2005
Last Verified
June 1, 2005
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CV787-9902
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.