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NPI-0052

Phase 1

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 Enrollment51

FDA Designations

No designations recorded

Clinical trial landscape

NPI-0052 · 1 trial · 2 indications

Phase 1 1
NCT00396864Phase 1 Clinical Trial of NPI-0052 in Patients With Advanced Solid Tumor Malignancies or Refractory LymphomaCancer
COMPLETED51 Analytics
PHASE1COMPLETED
Phase 1 Clinical Trial of NPI-0052 in Patients With Advanced Solid Tumor Malignancies or Refractory Lymphoma
CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety
Continuous
Maximum Tolerated Dose (MTD)
Continuous
Pharmacokinetics
Continuous

Secondary Endpoints

Pharmacodynamics
Continuous
Response
Continous
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
NPI-0052EXPERIMENTALAdvanced Solid Tumor Malignancies and Refractory Lymphoma

Interventions

NameTypeDescription
NPI-0052DRUGNPI-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
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Eligibility Criteria

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

Inclusion Criteria: * Histologically-confirmed solid tumor malignancy (patients must be refractory to or demonstrate unacceptable toxicity towards effective therapy known to provide clinical benefit for their condition) OR refractory lymphoma (patients whose disease has progressed despite standard ...

Countries:United States
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Frequently asked questions about NPI-0052

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.