Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00667082 | NPI-0052 and Vorinostat in Patients With Non-small Cell Lung Cancer, Pancreatic Cancer, Melanoma or Lymphoma | PHASE1 | COMPLETED | 22 | — | — | Mar 1, 2008 | Jan 1, 2010 | Nov 22, 2017 | 3 | Australia |
| Arm | Type | Description |
|---|---|---|
| NPI-0052 + Vorinostat Dose-Escalation | EXPERIMENTAL | 4 dose-escalation cohorts |
| Name | Type | Description |
|---|---|---|
| NPI-0052 (marizomib) + vorinostat | DRUG | NPI-0052 IV injection over 1 to 10 minutes at doses ranging from 0.15 to 0.7 mg/m2 on Days 1, 8, and 15 of each 28-day Cycle Oral vorinostat 300 mg was administered with food on Days 1 to 16 of each 28-day Cycle |
Inclusion Criteria: 1. Karnofsky Performance Status (KPS) at 70% or more. 2. Non-small cell lung cancer, pancreatic adenocarcinoma, melanoma or lymphoma for which a standard, approved therapy is not available. Patients must have lesions that are evaluable by RECIST criteria. 3. All Adverse Events o...