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

NCT03808870 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2023-08-15

No results posted yet for this study

Summary

NBM-BMX is an orally available new chemical entity to inhibit HDAC8 activity specifically, being developed as a potential anti-cancer therapeutic by NatureWise. The objectives of this study are to evaluate the safety, pharmacokinetics, and preliminary efficacy of NBM-BMX as monotherapy in subjects with advanced solid tumors (Arm A) or in combination with the standard of care treatment (i.e., concomitant RT/TMZ followed by adjuvant TMZ) in subjects with newly diagnosed glioblastoma (Arm B).

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

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-28
Primary Completion
2022-02-12
Completion
2022-02-16
FDA Drug
Yes

Countries

  • Taiwan

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 NCT03808870 on ClinicalTrials.gov