Expanded Access to Provide Selitrectinib for the Treatment of Cancers With a NTRK Gene Fusion
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expanded_access
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Brief Summary
Selitrectinib expanded access is for minor and adult patients with cancer having a change in a particular gene (NTRK1, NTRK2, or NTRK3 gene fusion). The patients are ineligible for an ongoing selitrectinib clinical trial or have other considerations that prevent access to selitrectinib through an existing clinical trial. Expanded access is intended to treat individual patients with different types of cancers with a NTRK gene fusion, including blood cancers, who have previously received tropomyosin receptor kinase (TRK) inhibitor therapy.
Trial Health
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 29, 2017
CompletedFirst Posted
Study publicly available on registry
July 2, 2017
CompletedSeptember 16, 2021
September 1, 2021
June 29, 2017
September 8, 2021
Conditions
Keywords
Interventions
Selitrectinib is administered as capsules or liquid formulation.
Eligibility Criteria
You may qualify if:
- Diagnosis of cancer with a NTRK1, NTRK2, and NTRK3 gene fusion
- Previous treatment with a kinase inhibitor with known activity on TRK inhibition
- Unable to participate in an ongoing selitrectinib clinical trial
- Medically suitable for treatment with selitrectinib
You may not qualify if:
- Currently enrolled in an ongoing clinical study with a TRK inhibitor
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- expanded access
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 29, 2017
First Posted
July 2, 2017
Last Updated
September 16, 2021
Record last verified: 2021-09