drugset / Trial / NCT02029729

RTA 408 in the Treatment of Advanced Solid Tumors (NSCLC & Melanoma) - DISCOVER

NCT02029729

Phase 1 Completed 11 enrolled Biogen AbbVie · collab
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

EvaluationDrugModalityDoseRoute
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