NCT00116155

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.

Trial Health

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 27, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 28, 2005

Completed
Last Updated

June 28, 2005

Status Verified

June 1, 2005

First QC Date

June 27, 2005

Last Update Submit

June 27, 2005

Conditions

Prostate Cancer

Keywords

Hormone Refractory Metastatic Prostate Cancer

Outcome Measures

Primary Outcomes (1)

  • 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 (4)

  • 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

Interventions

CV787 (CG7870)BIOLOGICAL

Sponsors & Collaborators

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 27, 2005

First Posted

June 28, 2005

Last Updated

June 28, 2005

Record last verified: 2005-06