Trial of IV Injection of CV787 in 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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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Study type

Interventional

Phase

Phase 1 / Phase 2

Treatment and study plan

CV787 (CG7870)

Biological

Primary outcomes

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 outcomes

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

Sponsors and collaborators

Lead sponsor

Cell Genesys

Industry

Registry information

Official study 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

Important dates

First posted: Jun 28, 2005
Registry last updated: Jun 28, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed