NCT00066196

Evaluating The Antitumor Activity Of MEDI-522 With Or Without Dacarbazine In Patients With Metastatic Melanoma

A Phase II, Randomized, Open-Label Study Evaluating The Antitumor Activity Of MEDI-522, A Humanized Monoclonal Antibody Directed Against The Human Alpha V Beta 3 Integrin, ± Dacarbazine In Patients With Metastatic Melanoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 110 (planned)
• Sponsor: MedImmune LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objectives of this study are: * To explore the antitumor activity of MEDI-522 ± DTIC in patients with metastatic melanoma. * To determine the safety of MEDI-522 ± DTIC in this patient population.

Detailed description

This is a Phase II, randomized, open-label, two-arm, multicenter study of MEDI 522 ± DTIC in previously untreated (other than adjuvant immunotherapy) patients with Stage IV metastatic melanoma (AJCC staging).

Conditions

• Melanoma
• Malignant Metastatic Melanoma

Interventions

Type	Name	Description
BIOLOGICAL	MEDI--522	IV administration supplied in 10 mL vials containing 100 mg of MEDI-522 at a concentration of 10 mg/mL.
BIOLOGICAL	Integrin + Dacarbazine	supplied in other formulations

Timeline

• Start date: 2003-08-01
• Primary completion: 2007-04-01
• Completion: 2007-06-01
• First posted: 2003-08-07
• Last updated: 2008-01-15

Locations

25 sites across 1 country: United States