drugset / Trial / NCT00150462

Safety Study of the Proteasome Inhibitor PR-171 (Carfilzomib for Injection) in Patients With Hematological Malignancies

NCT00150462

Phase 1 Completed 48 enrolled Amgen
Non-randomizedSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to test the safety and tolerability of carfilzomib at different dose levels on hematological cancers such as multiple myeloma, non-Hodgkin's lymphoma, Hodgkin's disease, or Waldenstrom's macroglobulinemia. Carfilzomib is a proteasome inhibitor, an enzyme responsible for degrading a wide variety of cellular proteins.

Timeline

Start
2005-09
Primary completion
2009-10
Completion
2009-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Carfilzomib Other / unclassified 1.2 mg/m2 Intravenous
Subject Carfilzomib Other / unclassified 2.4 mg/m2 Intravenous
Subject Carfilzomib Other / unclassified 4 mg/m2 Intravenous
Subject Carfilzomib Other / unclassified 6 mg/m2 Intravenous
Subject Carfilzomib Other / unclassified 8.4 mg/m2 Intravenous
Subject Carfilzomib Other / unclassified 11 mg/m2 Intravenous
Subject Carfilzomib Other / unclassified 20 mg/m2 Intravenous
Subject Carfilzomib Other / unclassified 27 mg/m2 Intravenous
Background Dexamethasone Small molecule 20 mg Oral