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

Status

Completed

Conditions

Intervention / Treatment

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

Cell Genesys

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

Keywords

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.

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