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Also known as NPI-0052
NPI-0052+ vorinostat · 2 trials · 7 indications
| Arm | Type | Description |
|---|---|---|
| NPI-0052 + Vorinostat Dose-Escalation | EXPERIMENTAL | 4 dose-escalation cohorts |
| NPI-0052 | EXPERIMENTAL | Advanced Solid Tumor Malignancies and Refractory Lymphoma |
| 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 |
| NPI-0052 | DRUG | NPI-0052 IV injection at doses ranging from 0.0125 to 0.8 mg/m2 over 1 to 10 minutes on Day 1, Day 8, Day 15 of each 28-day Cycle; 11 dose cohorts during dose-escalation |
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...
Top 2 of 4 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| GE Healthcare Technologies Inc. | GEHC | 1 | PHASE1 | GEH200520/GEH200521 |
| Ascentage Pharma Group International Unsponsored ADR | AAPG | 1 | PHASE1 | Olverembatinib |
NPI-0052 plus vorinostat is an investigational combination studied in adults with cancer. Trials have enrolled patients with non-small cell lung cancer, pancreatic cancer, melanoma, lymphoma, and multiple myeloma. It has been tested in advanced solid tumors and refractory lymphoma, and remains in clinical development rather than routine use.
Bristol-Myers Squibb Company, which trades under the ticker BMY, is the developer of the NPI-0052 plus vorinostat combination. The company sponsored the Phase 1 studies that evaluated the two agents together in patients with advanced malignancies.
NPI-0052 plus vorinostat is in Phase 1 development. The combination has been evaluated in early-stage clinical trials, and no Phase 2 or later studies of the combination are recorded. It is investigational and has not been approved for any indication.
Two completed Phase 1 trials studied the combination. NCT00667082 tested NPI-0052 with vorinostat in patients with non-small cell lung cancer, pancreatic cancer, melanoma, or lymphoma in Australia. NCT00396864 evaluated NPI-0052 in advanced solid tumors or refractory lymphoma in the United States. Both trials are completed.
Yes. NPI-0052 is also known as marizomib, so the combination NPI-0052 plus vorinostat is the same as marizomib plus vorinostat. Searches for either name refer to the same investigational agent paired with vorinostat in these Phase 1 oncology trials.
The clinical program enrolled 51 patients in total. NCT00396864 enrolled 51 participants with advanced solid tumors or refractory lymphoma, while NCT00667082 enrolled 22 patients with non-small cell lung cancer, pancreatic cancer, melanoma, or lymphoma. Both studies were single-arm Phase 1 trials without randomization or blinding.