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NCT00150462 · ClinicalTrials.gov registry record · Phase 1
Safety Study of the Proteasome Inhibitor PR-171 (Carfilzomib for Injection) in Patients With Hematological Malignancies
A Phase 1 study, sponsored by Amgen.
- Completed
- Registry status
- Phase 1
- Development phase
- 48
- Enrollment target
NCT00150462: Completed Phase 1 study, sponsored by Amgen.
NCT00150462 is a Phase 1 study that has completed, run by Amgen. The registered enrollment target is 48 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00150462, a Phase 1 study, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 48 participants
- Enrollment target
Study 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.
Primary Outcome
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 (
Interventions
- DRUG Dexamethasone
- DRUG Carfilzomib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2005-09 |
| Est. Completion | 2009-10 |
| Phase | Phase 1 |
What the finished NCT00150462 record still lists
NCT00150462 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% lower).
The record links to 0 conditions, and to 2 interventions - of which Dexamethasone is the first listed.
NCT00150462 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00150462 about?
NCT00150462 is a clinical study titled "Safety Study of the Proteasome Inhibitor PR-171 (Carfilzomib for Injection) 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 ...
What is the current status of trial NCT00150462?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 48 participants. The study started on 2005-09. Estimated completion is 2009-10.
What interventions are being tested in trial NCT00150462?
The interventions under investigation include: Dexamethasone (DRUG), Carfilzomib (DRUG).
Who is sponsoring clinical trial NCT00150462?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00150462's enrollment target sits among peer trials
48 1025th of 2000 higher than 948 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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