NCT00284804

A Phase II Study of MDX-060 in Subjects With Relapsed or Refractory Hodgkin's Disease

An Open-label, Randomized, Multicenter, Phase II Study of MDX-060 in Combination With Gemcitabine, MDX060 in Combination With Dexamethasone, and Gemcitabine Monotherapy in Patients With Relapsed or Refractory Hodgkin's Disease

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 74 (actual)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to determine the objective response rate in patients with relapsed or refractory Hodgkin's disease treated with MDX-060 in combination with gemcitabine or gemcitabine alone.

Detailed description

Secondary objectives include: * to characterize progression-free survival * to characterize time to progression * to determine response duration * to characterize the effect of study drug on health-related quality of life * to explore the correlation of positron emission tomography (PET) scan results with objective responses observed with conventional imaging in this patient population * to characterize the immunogenicity response of MDX-060 * to characterize the safety of MDX-060, and * to characterize the pharmacokinetic profile of MDX-060

Conditions

• Hodgkin's Disease

Interventions

Type	Name	Description
DRUG	MDX-060	anti-CD30 monoclonal antibody, i.v. weekly x 3 10 mg/kg

Timeline

• Start date: 2005-11-01
• Primary completion: 2008-05-01
• Completion: 2009-10-01
• First posted: 2006-02-01
• Last updated: 2015-10-12

Locations

17 sites across 1 country: United States