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NCT02029729 · ClinicalTrials.gov registry record · Phase 1
RTA 408 in the Treatment of Advanced Solid Tumors (NSCLC & Melanoma) - DISCOVER
A Phase 1 study of Metastatic or Incurable Non-small Cell Lung Cancer and Relapsed, Refractory Melanoma, sponsored by Biogen.
- Completed
- Registry status
- Phase 1
- Development phase
- 11
- Enrollment target
- 1
- Study location
NCT02029729: Completed Phase 1 study of Metastatic or Incurable Non-small Cell Lung Cancer and Relapsed, Refractory Melanoma, sponsored by Biogen.
NCT02029729 is a Phase 1 study of Metastatic or Incurable Non-small Cell Lung Cancer and Relapsed, Refractory Melanoma that has completed, run by Biogen. The registered enrollment target is 11 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (82% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02029729, a Phase 1 study of Metastatic or Incurable Non-small Cell Lung Cancer and Relapsed, Refractory Melanoma, has completed, sponsored by Biogen.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 11 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
To determine the recommended Phase 2 dose of RTA 408 following oral administration to patients with metastatic or incurable NSCLC or melanoma that is relapsed, refractory after standard of care therapy, or for which standard of care therapy is not appropriate.
Conditions Studied
Interventions
- DRUG omaveloxolone
Study Locations (1)
Florida
- H. Lee Moffitt Cancer Center (NSCLC) - Tampa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2013-12-31 |
| Est. Completion | 2015-10-01 |
| Phase | Phase 1 |
What the finished NCT02029729 record still lists
NCT02029729 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (82% lower).
The record links to 2 conditions, with Metastatic or Incurable Non-small Cell Lung Cancer appearing as the primary indexed condition, and to 1 intervention - of which omaveloxolone is the first listed.
NCT02029729 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT02029729 about?
NCT02029729 is a clinical study titled "RTA 408 in the Treatment of Advanced Solid Tumors (NSCLC & Melanoma) - DISCOVER". 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 s...
What is the current status of trial NCT02029729?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 11 participants. The study started on 2013-12-31. Estimated completion is 2015-10-01.
What conditions does trial NCT02029729 study?
This clinical trial studies the following conditions: Metastatic or Incurable Non-small Cell Lung Cancer, Relapsed, Refractory Melanoma.
What interventions are being tested in trial NCT02029729?
The interventions under investigation include: omaveloxolone (DRUG).
Who is sponsoring clinical trial NCT02029729?
This trial is sponsored by Biogen, which has 334 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02029729 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02029729's enrollment target sits among peer trials
11 1911th of 2000 higher than 88 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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