Comparison Study of MDX-010 (CTLA-4) Alone and Combined With Docetaxel in the Treatment of Patients With Hormone Refractory Prostate Cancer

Bristol-Myers Squibb (BMS)

Status and phase

Completed

Phase 2

Conditions

Prostate Cancer

Treatments

Drug: MDX-010 / MDX-010 + Docetaxel

Study type

Interventional

Funder types

Industry

Identifiers

NCT00050596

CA184-019 (Other Identifier)

MDX010-07

Details and patient eligibility

About

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

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.