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

2014-08-27 03:46:24 | BioPortfolio

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.

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

Study Design

Allocation: Randomized, Control: Dose Comparison, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Hodgkin's Disease

Intervention

MDX-060

Location

City of Hope, National Medical Center
Duarte
California
United States
91010

Status

Completed

Source

Bristol-Myers Squibb

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:46:24-0400

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