Comparison Study of MDX-010 (CTLA-4) Alone and Combined With Docetaxel in the Treatment of Patients With Hormone Refractory Prostate Cancer
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00050596 |
Recruitment Status :
Completed
First Posted : December 17, 2002
Last Update Posted : June 27, 2011
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Prostate Cancer | Drug: MDX-010 / MDX-010 + Docetaxel | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Study Start Date : | November 2002 |
Actual Primary Completion Date : | November 2004 |
Actual Study Completion Date : | November 2004 |


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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00050596
United States, Arizona | |
Advanced Clinical Therapeutics | |
Tucson, Arizona, United States, 85712 | |
United States, California | |
Pacific Shores Medical Group | |
Long Beach, California, United States, 90813 | |
San Diego Uro-Research | |
San Diego, California, United States, 92101 | |
United States, Louisiana | |
LSU Health Science Center/ Stanley S. Scott Cancer Center (uptown campus) | |
New Orleans, Louisiana, United States, 70112 | |
United States, Pennsylvania | |
Milton S. Hershey Medical Center | |
Hershey, Pennsylvania, United States, 17033 | |
United States, Rhode Island | |
University Urological Research Institute | |
Providence, Rhode Island, United States, 02906 | |
United States, South Carolina | |
Grand Strand Urology | |
Myrtle Beach, South Carolina, United States, 29572 | |
United States, Texas | |
Urology Associates of North Texas | |
Arlington, Texas, United States, 76012 | |
United States, Utah | |
Utah Cancer Specialists | |
Salt Lake City, Utah, United States, 84106 | |
Salt Lake Research | |
Salt Lake City, Utah, United States, 84124 | |
United States, Washington | |
Seattle Cancer Center Alliance | |
Seattle, Washington, United States, 98109-1023 |
Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Responsible Party: | Study Director, Bristol-Myers Squibb |
ClinicalTrials.gov Identifier: | NCT00050596 |
Other Study ID Numbers: |
MDX010-07 CA184-019 ( Other Identifier: BMS ) |
First Posted: | December 17, 2002 Key Record Dates |
Last Update Posted: | June 27, 2011 |
Last Verified: | June 2011 |
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Prostatic Diseases Docetaxel |
Ipilimumab Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Immunological |