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Trial record 21 of 37 for:    Recruiting, Not yet recruiting, Available Studies | Receptor tyrosine kinase

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

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ClinicalTrials.gov Identifier: NCT03025360
Expanded Access Status : Available
First Posted : January 19, 2017
Last Update Posted : March 13, 2019
Sponsor:
Information provided by (Responsible Party):
Bayer

Brief Summary:

Larotrectinib expanded access is for patients with cancer with a NTRK1, NTRK2, or NTRK3 gene fusion, who are ineligible for an ongoing larotrectinib clinical trial or have other considerations that prevent access to larotrectinib through an existing clinical trial. Gene fusion occurs when a gene is made by joining parts of two different genes. NTRK gene fusion can lead to the development of solid tumors in a variety of tissue types. The study drug larotrectinib blocks the action of the NTRK gene fusion.

Expanded access is intended to treat individual patients with different types of cancers with a NTRK gene fusion who are unresponsive to current standard treatment for their condition and also are unable to participate in ongoing clinical trials.


Condition or disease Intervention/treatment
Tumors Habouring NTRK Fusion Drug: Larotrectinib (Vitrakvi, BAY2757556)

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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 Larotrectinib (LOXO-101) for the Treatment of Cancers With a NTRK Gene Fusion

Resource links provided by the National Library of Medicine



Intervention Details:
  • Drug: Larotrectinib (Vitrakvi, BAY2757556)
    Larotrectinib will be administered orally as capsule or liquid solution as specified by the treating physician.
    Other Name: LOXO-101

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of cancer with a NTRK1, NTRK2, or NTRK3 gene fusion
  • Subjects are unable to participate in an ongoing larotrectinib clinical trial
  • Medically suitable for treatment with larotrectinib

Exclusion Criteria:

  • Currently enrolled in an ongoing clinical study of larotrectinib or another 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): NCT03025360


Contacts
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Contact: Bayer Clinical Trials Contact (+)1-888-84 22937 clinical-trials-contact@bayer.com

Sponsors and Collaborators
Bayer

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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT03025360     History of Changes
Other Study ID Numbers: 20366
First Posted: January 19, 2017    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: March 2019

Keywords provided by Bayer:
Neurotrophic tyrosine receptor kinase (NTRK)
NTRK1
NTRK2
NTRK3
Fusion Positive