Comparison Study of MDX-010 (CTLA-4) Alone and Combined With Docetaxel in the Treatment of Patients With Hormone Refractory Prostate Cancer
A Randomized Study Comparing 4 Monthly Doses of MDX-010 (CTLA-4) as a Single Agent or Used in Combination With a Single Dose of Docetaxel in Patients With Hormone-Refractory Prostate Cancer
2 other identifiers
interventional
N/A
1 country
11
Brief Summary
The primary objectives of the study are to determine the safety and activity of multiple doses of MDX-010 in patients with hormone-refractory prostate cancer (HRPC), and to determine the safety and activity profile of a single dose of cytotoxic chemotherapy (docetaxel) in combination with MDX-010
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Nov 2002
Shorter than P25 for phase_2 prostate-cancer
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2002
CompletedFirst Submitted
Initial submission to the registry
December 16, 2002
CompletedFirst Posted
Study publicly available on registry
December 17, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2004
CompletedJune 27, 2011
June 1, 2011
2 years
December 16, 2002
June 23, 2011
Conditions
Interventions
Eligibility Criteria
You may qualify if:
- Clinical diagnosis of adenocarcinoma of the prostate.
- Metastatic prostate cancer (positive bone scan or measurable disease).
- Progressive disease after androgen deprivation.
- No prior chemotherapy or immunotherapy (tumor vaccine, cytokine, or growth factor given to control prostate cancer).
You may not qualify if:
- Other prior malignancy, except for adequately treated basal or squamous cell skin cancer or superficial bladder cancer, or any other cancer from which the patient has been disease-free for greater than or equal to 5 years.
- Previous occurrence of autoimmune disease.
- Active infection requiring therapy including HIV or chronic hepatitis.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
Advanced Clinical Therapeutics
Tucson, Arizona, 85712, United States
Pacific Shores Medical Group
Long Beach, California, 90813, United States
San Diego Uro-Research
San Diego, California, 92101, United States
LSU Health Science Center/ Stanley S. Scott Cancer Center (uptown campus)
New Orleans, Louisiana, 70112, United States
Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
University Urological Research Institute
Providence, Rhode Island, 02906, United States
Grand Strand Urology
Myrtle Beach, South Carolina, 29572, United States
Urology Associates of North Texas
Arlington, Texas, 76012, United States
Utah Cancer Specialists
Salt Lake City, Utah, 84106, United States
Salt Lake Research
Salt Lake City, Utah, 84124, United States
Seattle Cancer Center Alliance
Seattle, Washington, 98109-1023, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
December 16, 2002
First Posted
December 17, 2002
Study Start
November 1, 2002
Primary Completion
November 1, 2004
Study Completion
November 1, 2004
Last Updated
June 27, 2011
Record last verified: 2011-06