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Brief Title: RTA 408 in the Treatment of Advanced Solid Tumors (NSCLC & Melanoma) - DISCOVER
Official Title: An Open-Label, Single-Center, Dose-Escalation, Phase 1 Study of the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of RTA 408 in the Treatment of Patients With Advanced Solid Tumors
Study ID: NCT02029729
Brief 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.
Detailed Description: Study Sponsor, originally Reata Pharmaceuticals, Inc., is now Reata Pharmaceuticals, Inc., a wholly owned subsidiary of Biogen.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
H. Lee Moffitt Cancer Center (NSCLC), Tampa, Florida, United States