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A Phase I Study of the Safety and Pharmacokinetics of Escalating Intravenous Doses of the Proteasome Inhibitor PR-171 in Patients With Hematological Malignancies
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.
Details
| Lead sponsor | Amgen |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 48 |
| Start date | 2005-09 |
| Completion | 2009-10 |
Conditions
- Waldenstrom's Macroglobulinemia
- Non-Hodgkin's Lymphoma
- Hodgkin's Disease
- Multiple Myeloma
Interventions
- Carfilzomib
- Dexamethasone
Primary outcomes
- Number of Participants With Dose-limiting Toxicities (DLTs) — 28 days
A DLT was defined as any of the following occurring in the first 28 days of study participation: Nonhematologic: * \> Grade 2 neuropathy with pain * ≥ Grade 3 nonhematologic toxicity (excluding nausea, vomiting, or diarrhea) * ≥ Grade 3 nausea, vomiting, or diarrhea uncontrolled by maximal antiemetic/antidiarrheal therapy Hematologic: * Grade 4 neutropenia (absolute neutrophil count \[ANC\] \< 0.5 × 10ˆ9/L) lasting ≥ 14 days without hematopoietic growth factor support * Febrile neutropenia (ANC \< 1.0 × 10ˆ9/L with a fever ≥ 38.3°C) * Grade 4 thrombocytopenia (platelets \< 25.0 × 10ˆ9/L) or thrombocytopenia associated with bleeding. Toxicities were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) of the National Cancer Institute (NCI) version 3.0. - Maximum Observed Plasma Concentration of Carfilzomib (Cmax) — Cycle 1, Day 1 at predose, 5, 15, and 30 minutes, and 1, 2, 4, and 24 hours post dose.
- Time to Maximum Observed Plasma Concentration of Carfilzomib (Tmax) — Cycle 1, Day 1 at predose, 5, 15, and 30 minutes, and 1, 2, 4, and 24 hours post dose.
- Area Under the Concentration-time Curve to Last Measureable Timepoint (AUClast) for Carfilzomib — Cycle 1, Day 1 at predose, 5, 15, and 30 minutes, and 1, 2, 4, and 24 hours post dose.
- Area Under the Concentration-time Curve Extrapolated to Infinity (AUCinf) for Carfilzomib — Cycle 1, Day 1 at predose, 5, 15, and 30 minutes, and 1, 2, 4, and 24 hours post dose.
Countries
United States