NCT00323882

Study of MDX-010 in Patients With Metastatic Hormone-Refractory Prostate Cancer

A Phase I/II, Open-label, Dose-escalation Study of MDX-010 Administered Every 3 Weeks for 4 Doses in Patients With Metastatic Hormone-Refractory Prostate Cancer

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Multicenter study in which patients with metastatic hormone refractory prostate cancer (HRPC), who have not had previous chemotherapy or immunotherapy treatments, received MDX-010 every 3 weeks for 4 doses (12 weeks total duration of induction). MDX-010 was administered at escalating dosage levels of 3, 5, and 10 mg/kg/dose infusions. At least 6 patients were to be enrolled in each dosage level. Patients who tolerated and responded to treatment or who had stable disease for 3 months or longer and who subsequently progressed during the follow up phase of the study had the option to receive additional treatment with MDX-010, up to 4 cycles. Patients were followed in the study for response up to 2 years and were followed for survival status for up to 5 years after enrollment.

Conditions

• Prostate Cancer
• Neoplasm Metastasis

Interventions

Type	Name	Description
DRUG	MDX-010	selected dose administered IV every 3 weeks

Timeline

• Start date: 2006-01-01
• Primary completion: 2009-09-01
• Completion: 2013-07-01
• First posted: 2006-05-10
• Last updated: 2014-08-28
• Results posted: 2014-08-28

Locations

14 sites across 1 country: United States