Back to resultsExpanded Access to Omaveloxolone for Melanoma for Patients Previously Enrolled in 408-C-1401
Primary Purpose
Melanoma
Status
No longer available
Phase
Locations
Study Type
Expanded Access
Intervention
omaveloxolone
Sponsored by
About this trial
This is an expanded access trial for Melanoma focused on measuring melanoma, omaveloxolone, expanded access
Eligibility Criteria
Inclusion Criteria:
-
Exclusion Criteria:
-
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03593499
Brief Title
Expanded Access to Omaveloxolone for Melanoma for Patients Previously Enrolled in 408-C-1401
Study Type
Expanded Access
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
No longer available
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biogen
4. Oversight
5. Study Description
Brief Summary
This is an expanded access program for eligible participants and is designed to provide access to omaveloxolone for the treatment of unresectable or metastatic melanoma to patients who previously participated in the 408-C-1401 (REVEAL) study. To be considered for expanded access, a Principal Investigator from the REVEAL trial should submit a request to Reata Pharmaceuticals on behalf of the individual patient.
Detailed Description
This study was previously posted by Reata Pharmaceuticals. In September 2023, sponsorship of the trial was transferred to Biogen.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma
Keywords
melanoma, omaveloxolone, expanded access
7. Study Design
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
omaveloxolone
Other Intervention Name(s)
RTA 408
10. Eligibility
Eligibility Criteria
Inclusion Criteria:
-
Exclusion Criteria:
-
12. IPD Sharing Statement
Learn more about this trial
Expanded Access to Omaveloxolone for Melanoma for Patients Previously Enrolled in 408-C-1401
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