Trials / Completed
CompletedNCT03808870
A Safety and Pharmacokinetic Study of NBM-BMX Administered Orally to Asian Patients With Advanced Cancer
A Phase 1, Open-label, Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Efficacy of NBM-BMX in Asian Subjects With Advanced Solid Tumors
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 21 (actual)
- Sponsor
- NatureWise Biotech & Medicals Corporation · Industry
- Sex
- All
- Age
- 20 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | NBM-BMX softgel capsules | Patients will initially receive NBM-BMX orally once a day at 100 mg per day. |
Timeline
- Start date
- 2018-12-28
- Primary completion
- 2022-02-12
- Completion
- 2022-02-16
- First posted
- 2019-01-18
- Last updated
- 2023-08-15
Locations
2 sites across 1 country: Taiwan
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03808870. Inclusion in this directory is not an endorsement.