Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
NPI-0052+ vorinostat · 1 trial · 5 indications
| 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...
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NPI-0052 is an investigational small molecule being studied for the treatment of non-small cell lung cancer and other cancers. It is in Phase 1 clinical development and is not yet approved by the FDA.
NPI-0052 is being developed by Bristol-Myers Squibb Company, which is listed on the New York Stock Exchange under the ticker symbol BMY.
NPI-0052 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA for any use.
NPI-0052 has been studied in two completed Phase 1 trials. NCT00396864 enrolled 51 patients with advanced solid tumors or refractory lymphoma in the United States. NCT00667082 enrolled 22 patients with non-small cell lung cancer, pancreatic cancer, melanoma, lymphoma, or multiple myeloma in Australia.
NPI-0052 is also known as marizomib. It is a proteasome inhibitor being investigated for its anticancer activity.