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A Safety and Pharmacokinetic Study of NBM-BMX Administered Orally to Patients With Advanced Cancer

NCT03726294 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2022-04-13

No results posted yet for this study

Summary

NBM-BMX is a new small molecule chemical entity being developed as a potential anti-cancer therapeutic by NatureWise. NBM-BMX is a histone deacetylase (HDAC) inhibitor and has been shown to be particularly active against HDAC8. The objectives of this study are to determine the safety profile of NBM-BMX, including identification of dose limiting toxicity (DLT) and maximum tolerated dose (MTD), and to determine the Recommended Phase 2 Dose (RP2D).

Conditions

  • Malignant Neoplasm

Interventions

DRUG

NBM-BMX softgel capsules

Patients will initially receive NBM-BMX orally once a day at 100 mg per day.

Sponsors & Collaborators

  • NatureWise Biotech & Medicals Corporation

    lead INDUSTRY

Principal Investigators

  • Anthony W. Tolcher, M.D. · NEXT Oncology

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-16
Primary Completion
2020-04-24
Completion
2021-10-25
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03726294 on ClinicalTrials.gov