Phase 1b/2, Multicenter, Open-label Study of the Safety and Activity of Oprozomib in Patients With Hematologic Malignancies
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Determine the MTD (Phase 1) and ORR (Phase 2).
Phase 1- Determine Maximum Tolerated Dose (MTD) with 3 + 3 Dose Escalation Cohorts in patients hematologic malignancies. Phase 2- The Phase 2 portion of this trial will enroll patients with Multiple Myeloma (MM) and Waldenstrom Macroglobulinemia (WM) into separate arms to assess activity of oprozomib in these patient groups. The purpose of the Phase 2 portion of the study is to estimate the best ORR (for each group separately).
6 weeks to 18 months
Study Director, MD
Onyx Therapeutics, Inc.
United States: Food and Drug Administration
|Mount Sinai Medical Center||New York, New York 10029|
|Dana Farber Cancer Institute||Boston, Massachusetts 02115|
|University of Maryland, Greenebaum Cancer Center||Baltimore, Maryland 21201|
|Winship Cancer Institute, Emory University||Atlanta, Georgia 30322|
|Tennessee Oncology, PLLC||Clarksville, Tennessee 37043|
|South Texas Accelerated Research Therapeutics||San Antonio, Texas 78229|
|Oncology Research Associates||Scottsdale, Arizona 85258|
|John Theurer Cancer Center at Hackensack University||Hackensack, New Jersey 07601|
|Washington University School of Medicine Division of Oncology||St. Louis, Missouri 63110|