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NPI-0052+ vorinostat

Phase 1

Non-Small Cell Lung Cancer | Small molecule | Oncology |Bristol-Myers Squibb Company|Last Updated: Nov 22, 2017

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment22

FDA Designations

No designations recorded

Clinical trial landscape

NPI-0052+ vorinostat · 1 trial · 5 indications

Phase 1 1
NCT00667082NPI-0052 and Vorinostat in Patients With Non-small Cell Lung Cancer, Pancreatic Cancer, Melanoma or LymphomaNon-Small Cell Lung Cancer
COMPLETED22 Analytics
PHASE1COMPLETED
NPI-0052 and Vorinostat in Patients With Non-small Cell Lung Cancer, Pancreatic Cancer, Melanoma or Lymphoma
Non-Small Cell Lung CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

To determine the Maximum tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of the combination NPI-0052 and Vorinostat
continuously

Secondary Endpoints

To evaluate the pharmacokinetics and pharmacodynamics of NPI-0052 and vorinostat
continuous
To evaluate the safety and toxicity profile of the combination of NPI-0052 and vorinostat
continuous
To evaluate the anti-tumor activity of NPI-0052 and vorinostat
continuous
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeOTHER

Treatment Arms

ArmTypeDescription
NPI-0052 + Vorinostat Dose-EscalationEXPERIMENTAL4 dose-escalation cohorts

Interventions

NameTypeDescription
NPI-0052 (marizomib) + vorinostatDRUGNPI-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
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites3

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...

Countries:Australia
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Competitive Landscape -Non-Small Cell Lung Cancer 389 trials

Frequently asked questions about NPI-0052+ vorinostat

What is NPI-0052 used for?

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.

Who makes NPI-0052?

NPI-0052 is being developed by Bristol-Myers Squibb Company, which is listed on the New York Stock Exchange under the ticker symbol BMY.

What phase is NPI-0052 in?

NPI-0052 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA for any use.

What clinical trials is NPI-0052 in?

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.

Is NPI-0052 the same as marizomib?

NPI-0052 is also known as marizomib. It is a proteasome inhibitor being investigated for its anticancer activity.