NCT00072930

MEDI-522 in the Treatment of Patients With Metastatic Androgen-Independent Prostate Cancer

Phase II, Randomized, Open-Label, Two-Arm, Multicenter Study of MEDI-522, a HuMA Directed Against the Human Alpha V Beta 3 Integrin, in Combination With Docetaxel, Prednisone, and Zoledronic Acid in the Treatment of Patients With Metastatic Androgen-Independent Prostate Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 150 (planned)
• Sponsor: MedImmune LLC · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objectives of this study are: 1. To explore the antitumor activity of MEDI-522 in combination with docetaxel, prednisone, and zoledronic acid in patients with metastatic Androgen-Independent Prostate Cancer (AIPC); and 2. To summarize the safety of MEDI-522 in combination with docetaxel, prednisone, and zoledronic acid in this patient population.

Detailed description

This is a Phase II, randomized, open-label, two-arm, multicenter study of MEDI-522 in combination with docetaxel, prednisone, and zoledronic acid in patients with metastatic AIPC.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
BIOLOGICAL	MEDI-522	IV at a concentration of 50 mg/mL and 10mL vials
BIOLOGICAL	Docetaxel + Prednisone* + Zoledronic Acid	IV 75 mg/m2 IV 3-4 mg 5 mg

Timeline

• Start date: 2003-12-01
• Primary completion: 2007-04-01
• Completion: 2007-06-01
• First posted: 2003-11-17
• Last updated: 2008-01-15

Locations

57 sites across 7 countries: United States, Belgium, Canada, Hungary, Israel, Poland, Russia