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Expanded Access to Provide Loxo-195 for the Treatment of Cancers With a NTRK Gene Fusion

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03206931
Expanded Access Status : Available
First Posted : July 2, 2017
Last Update Posted : September 26, 2019
Information provided by (Responsible Party):

Brief Summary:
Loxo-195 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 Loxo-195 clinical trial or have other considerations that prevent access to Loxo-195 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: BAY2731954

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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 LOXO-195 for the Treatment of Cancers With a NTRK Gene Fusion

Resource links provided by the National Library of Medicine

Intervention Details:
  • Drug: BAY2731954
    BAY2731954 is administered as capsules or liquid formulation.
    Other Name: Loxo-195

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

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 Loxo-195 clinical trial
  • Medically suitable for treatment with Loxo-195

Exclusion Criteria:

  • Currently enrolled in an ongoing clinical study with a TRK inhibitor

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03206931

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Contact: Bayer Clinical Trials Contact (+)1-888-84 22937

Sponsors and Collaborators

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Responsible Party: Bayer Identifier: NCT03206931     History of Changes
Other Study ID Numbers: 21002
First Posted: July 2, 2017    Key Record Dates
Last Update Posted: September 26, 2019
Last Verified: September 2019
Keywords provided by Bayer:
Metastatic cancer
Advanced cancer
Neurotrophic tyrosine receptor kinase (NTRK)
Fusion Positive
Additional relevant MeSH terms:
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Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action