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NCT00461045 · ClinicalTrials.gov registry record · Phase 2
Phase 2 Clinical Trial of NPI-0052 in Patients With Relapsed or Relapsed/Refractory Multiple Myeloma
A Phase 2 study, sponsored by Celgene.
- Completed
- Registry status
- Phase 2
- Development phase
- 15
- Enrollment target
NCT00461045: Completed Phase 2 study, sponsored by Celgene.
NCT00461045 is a Phase 2 study that has completed, run by Celgene. The registered enrollment target is 15 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00461045, a Phase 2 study, has completed, sponsored by Celgene.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 15 participants
- Enrollment target
Study Summary
This is a Phase 2, open-label, multicenter study examining the safety, pharmacokinetics and pharmacodynamics, and best overall response to escalating doses of the proteasome inhibitor NPI-0052 (also known as marizomib) in patients with relapsed or relapsed/refractory multiple myeloma. NPI-0052 is a novel, second generation proteasome inhibitor that prevents the breakdown of proteins involved in signal transduction which blocks growth and survival in cancer cells. The study is a Phase 2 study and is a 2-stage efficacy design in a selected subgroup of patients (Arm C) treated with the recommended phase 2 dose of NPI-0052, as determined in a previously completed Phase 1 study. The study is to evaluate the safety and any preliminary evidence of efficacy of NPI-0052 in multiple myeloma patients who have previously received carfilzomib (PR-171, Kyprolis™) and subsequently had disease progression.
Primary Outcome
Disease response and progression were determined by the investigator using the International Myeloma Working Group Uniform Response Criteria (IMWG-URC). Overall response rate includes patients with a best response of PR of better. Stringent complete response (CR) includes immunophenotypic CR and molecular CR in addition to stringent CR.
Interventions
- DRUG MRZ 0.5 mg/m^2
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2007-03 |
| Est. Completion | 2014-10 |
| Phase | Phase 2 |
What the finished NCT00461045 record still lists
NCT00461045 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 1 intervention - of which MRZ 0.5 mg/m^2 is the first listed.
NCT00461045 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00461045 about?
NCT00461045 is a clinical study titled "Phase 2 Clinical Trial of NPI-0052 in Patients With Relapsed or Relapsed/Refractory Multiple Myeloma". This is a Phase 2, open-label, multicenter study examining the safety, pharmacokinetics and pharmacodynamics, and best overall response to escalating doses of the proteasome inhibitor NPI-0052 (also known as marizomib) in patients with relapsed or relapsed/refractory multiple myeloma. NPI-0052 is a ...
What is the current status of trial NCT00461045?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 15 participants. The study started on 2007-03. Estimated completion is 2014-10.
What interventions are being tested in trial NCT00461045?
The interventions under investigation include: MRZ 0.5 mg/m^2 (DRUG).
Who is sponsoring clinical trial NCT00461045?
This trial is sponsored by Celgene, which has 308 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00461045's enrollment target sits among peer trials
15 1919th of 2000 higher than 60 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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