Brentuximab Vedotin (SGN-35) as Salvage Therapy for Males With Advanced and Platinum-resistant Germ-cell Tumors. An Open Label, Single Group, Phase 2 Trial.
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
The number of objective responses (partial and complete responses) according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 integrated with response of serum tumor markers.
Six weeks after the first administration of the study drug.
No
Alessandro M Gianni, MD
Study Chair
Fondazione IRCCS Istituto Nazionale dei Tumori
Italy: The Italian Medicines Agency
FM-12-GCT01
NCT01851200
May 2013
June 2015
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