Ignite Creation Date:
2024-05-05 @ 5:28 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00461045
Status:
COMPLETED
Last Update Posted:
2017-12-19
First Post:
2007-04-13
Brief Title:
Phase 2 Clinical Trial of NPI-0052 in Patients With Relapsed or RelapsedRefractory Multiple Myeloma
Sponsor:
Celgene
Organization:
Celgene
Study Overview
Official Title:
Phase 2 Clinical Trial of NPI-0052 in Patients With Relapsed or RelapsedRefractory Multiple Myeloma
Status:
COMPLETED
Status Verified Date:
2017-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 relapsedrefractory 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None