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

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ClinicalTrials.gov Identifier: NCT03206931
Expanded Access Status : Available
First Posted : July 2, 2017
Last Update Posted : March 1, 2018
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Loxo Oncology, Inc.

Brief Summary:
LOXO-195 expanded access is for patients with cancer with a NTRK1, NTRK2, or NTRK3 gene fusion who 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, including blood cancers, with a NTRK gene fusion who have previously received TRK inhibitor therapy

Condition or disease Intervention/treatment
Cancer Neurotrophic Tyrosine Kinase, Receptor-related Proteins Drug: LOXO-195

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: LOXO-195
    Open-label expanded access

Information from the National Library of Medicine

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Ages Eligible for Study:   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 LOXO-195 clinical trial
  • Willing and able to provide written, signed informed consent
  • 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 ClinicalTrials.gov identifier (NCT number): NCT03206931


Contacts
Contact: Patient Advocacy 1-855-NTRK-123 clinicaltrials@loxooncology.com

Sponsors and Collaborators
Loxo Oncology, Inc.
Bayer
Investigators
Study Director: Nora Ku, MD Loxo Oncology
Study Director: Michael Cox, PharmD, MHSc, BCOP Loxo Oncology

Responsible Party: Loxo Oncology, Inc.
ClinicalTrials.gov Identifier: NCT03206931     History of Changes
Other Study ID Numbers: LOXO-195 EAP
First Posted: July 2, 2017    Key Record Dates
Last Update Posted: March 1, 2018
Last Verified: February 2018