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Expanded Access to Provide Selitrectinib for the Treatment of Cancers With a NTRK Gene Fusion

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ClinicalTrials.gov Identifier: NCT03206931
Expanded Access Status : No longer available
First Posted : July 2, 2017
Last Update Posted : September 16, 2021
Sponsor:
Information provided by (Responsible Party):
Bayer

Study Description
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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.

Condition or disease Intervention/treatment
Solid Tumors Harboring NTRK Fusion Drug: Selitrectinib (BAY2731954)

Study Design
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Study Type : Expanded Access
Expanded Access Type : Individual Patients
  See clinical trials of the intervention/treatment in this expanded access record.
Official Title: Expanded Access to Provide Selitrectinib (BAY2731954) for the Treatment of Cancers With a NTRK Gene Fusion.

Resource links provided by the National Library of Medicine


Interventions
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Intervention Details:
  • Drug: Selitrectinib (BAY2731954)
    Selitrectinib is administered as capsules or liquid formulation.
    Other Name: Loxo-195
Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   1 Month and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Currently enrolled in an ongoing clinical study with a TRK inhibitor
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT03206931    
Other Study ID Numbers: 21002
First Posted: July 2, 2017    Key Record Dates
Last Update Posted: September 16, 2021
Last Verified: September 2021
Keywords provided by Bayer:
Metastatic cancer
Advanced cancer
Neurotrophic tyrosine receptor kinase (NTRK)
NTRK1
NTRK2
 NTRK3
Fusion Positive
Children
Loxo-195
Additional relevant MeSH terms:
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Selitrectinib
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action