NCT02029729

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Biogen · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Metastatic or Incurable Non-small Cell Lung Cancer
• Relapsed, Refractory Melanoma

Interventions

Type	Name	Description
DRUG	omaveloxolone

Timeline

• Start date: 2013-12-31
• Primary completion: 2015-10-01
• Completion: 2015-10-01
• First posted: 2014-01-08
• Last updated: 2025-05-29

Locations

1 site across 1 country: United States