drugset / Trial / NCT02029729
RTA 408 in the Treatment of Advanced Solid Tumors (NSCLC & Melanoma) - DISCOVER
NaSingle-groupOpen-labelTreatment
Summary
This proposed first-in-human study (408-C-1303) is designed to assess the safety, maximum tolerated dose, pharmacodynamics, and pharmacokinetics of omaveloxolone (RTA 408) in patients with advanced solid tumors that are refractory after standard of care therapy for the disease. The results of this study will help provide clinical information for the design and conduct of further clinical studies with RTA 408 in cancer patients.
Timeline
- Start
- 2013-12-31
- Primary completion
- 2015-10-01
- Completion
- 2015-10-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Omaveloxolone | Small molecule | 2.5 mg | — |
| Subject | Omaveloxolone | Small molecule | 5 mg | — |
| Subject | Omaveloxolone | Small molecule | 10 mg | — |
| Subject | Omaveloxolone | Small molecule | 20 mg | — |
| Subject | Omaveloxolone | Small molecule | 30 mg | — |
| Subject | Omaveloxolone | Small molecule | 45 mg | — |