Trials / Completed
CompletedNCT03726294
A Safety and Pharmacokinetic Study of NBM-BMX Administered Orally to Patients With Advanced Cancer
A Phase 1, Open-label, Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Efficacy of NBM-BMX in Subjects With Advanced Solid Tumors
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 33 (actual)
- Sponsor
- NatureWise Biotech & Medicals Corporation · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
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
- 2018-10-16
- Primary completion
- 2020-04-24
- Completion
- 2021-10-25
- First posted
- 2018-10-31
- Last updated
- 2022-04-13
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03726294. Inclusion in this directory is not an endorsement.