drugset / Trial / NCT00629473
Phase 1 Clinical Trial of NPI-0052 in Patients With Advanced Malignancies
Non-randomizedSingle-groupOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2007-07
- Primary completion
- 2013-04
- Completion
- 2013-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Marizomib | Small molecule | 0.075 mg/m2 | Intravenous |
| Subject | Marizomib | Small molecule | 0.1 mg/m2 | Intravenous |
| Subject | Marizomib | Small molecule | 0.6 mg/m2 | Intravenous |
| Subject | Marizomib | Small molecule | 0.9 mg/m2 | Intravenous |
| Background | Dexamethasone | Small molecule | 20 mg | Oral |