Trials / Completed
CompletedNCT02703298
Safety and Pharmacokinetic Study of TRX-818 in Asian Solid Tumor Patients
A Phase I Safety and Pharmacokinetic Study of TRX-818 Administered Orally to Patients With Advanced Solid Tumors in Asians
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 19 (actual)
- Sponsor
- TaiRx, Inc. · Industry
- Sex
- All
- Age
- 20 Years
- Healthy volunteers
- Not accepted
Summary
TRX-818 is a new small molecule chemical entity being developed as a potential anti-cancer therapeutic by TaiRx, Inc. TRX-818 is a potent anti-cancer agent in numerous human cancer cell lines. The objectives of this study are to determine the safety profile of TRX-818 including identification of dose limiting toxicity (DLT) and maximum tolerated dose (MTD) in Asians and determine the recommended dose and regimen(s) to initiate Phase 2.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | TRX-818 capsules |
Timeline
- Start date
- 2016-03-25
- Primary completion
- 2018-01-23
- Completion
- 2018-05-03
- First posted
- 2016-03-09
- Last updated
- 2019-03-28
Locations
1 site across 1 country: Taiwan
Source: ClinicalTrials.gov record NCT02703298. Inclusion in this directory is not an endorsement.