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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 is a Phase 2 study that has completed, run by Celgene. The registered enrollment target is 15 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00461045
The ClinicalTrials.gov registry entry for NCT00461045 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Celgene, which has 308 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which MRZ 0.5 mg/m^2 is the first listed.
NCT00461045 reports 0 study locations.
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.
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