Phase 2 Clinical Trial of NPI-0052 in Patients With Relapsed or Relapsed/Refractory Multiple Myeloma
Status:
Completed
Trial end date:
2014-10-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
Celgene Triphase Research and Development I Corporation