Phase 1 Clinical Trial of NPI-0052 in Patients With Advanced Solid Tumor Malignancies or Refractory Lymphoma
Completed
Celgene
Phase 1
Multicenter, open-label study of NPI-0052 in patients with advanced solid tumor malignancies
or refractory lymphoma whose disease had progressed after treatment with standard, approved
therapies that included 2 stages. The initial stage involved dose escalation to an MTD and
determination of a recommended Phase 2 dose. The second stage comprised an expansion cohort
at the recommended Phase 2 dose.
Phase 1 Clinical Trial of NPI-0052 in Patients With Advanced Solid Tumor Malignancies or Refractory Lymphoma
Completed
Triphase Research and Development I Corporation
Phase 1
Multicenter, open-label study of NPI-0052 in patients with advanced solid tumor malignancies
or refractory lymphoma whose disease had progressed after treatment with standard, approved
therapies that included 2 stages. The initial stage involved dose escalation to an MTD and
determination of a recommended Phase 2 dose. The second stage comprised an expansion cohort
at the recommended Phase 2 dose.
Phase 2 Clinical Trial of NPI-0052 in Patients With Relapsed or Relapsed/Refractory Multiple Myeloma
Completed
Celgene
Phase 2
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.
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