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A Phase 1 Clinical Trial of NPI-0052 in Patients With Advanced Malignancies
This is a Phase 1 clinical trial examining the safety, pharmacokinetics and pharmacodynamics of escalating doses of the proteasome inhibitor NPI-0052 in patients with advanced malignancies including solid tumors, lymphomas, leukemias and multiple myeloma. By inhibiting proteasomes NPI-0052 prevents the breakdown of proteins involved in signal transduction, which blocks growth and survival in cancer cells.
Details
| Lead sponsor | Celgene |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 86 |
| Start date | 2007-07 |
| Completion | 2013-04 |
Conditions
- Advanced Cancer
Interventions
- NPI-0052 on Days 1, 8, 15 every 28 days
- NPI-0052 on Days 1, 4, 8, 11 every 21 days
- Dexamethasone
Primary outcomes
- Determine Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of NPI-0052 — Cycle 1 (Arm AM: 28-days, Arm MM: 21-days)
Assess dose-limiting toxicities during Cycle 1 for each treatment arm
Countries
Australia