Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2026-02-26 @ 12:36 AM
Study NCT ID:
NCT03025360
Status:
APPROVED_FOR_MARKETING
Last Update Posted:
2019-12-19
First Post:
2017-01-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Expanded Access to Provide Larotrectinib for the Treatment of Cancers With a NTRK Gene Fusion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000609083', 'term': 'larotrectinib'}]}}, 'protocolSection': {'designModule': {'studyType': 'EXPANDED_ACCESS', 'expandedAccessTypes': {'individual': True}, 'nPtrsToThisExpAccNctId': 2}, 'statusModule': {'overallStatus': 'APPROVED_FOR_MARKETING', 'statusVerifiedDate': '2019-12', 'lastUpdateSubmitDate': '2019-12-18', 'studyFirstSubmitDate': '2017-01-16', 'studyFirstSubmitQcDate': '2017-01-16', 'lastUpdatePostDateStruct': {'date': '2019-12-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-01-19', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['Neurotrophic tyrosine receptor kinase (NTRK)', 'NTRK1', 'NTRK2', 'NTRK3', 'Fusion Positive'], 'conditions': ['Tumors Harboring NTRK Fusion']}, 'descriptionModule': {'briefSummary': '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.\n\nExpanded 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of cancer with a NTRK1, NTRK2, or NTRK3 gene fusion\n* Subjects are unable to participate in an ongoing larotrectinib clinical trial\n* Medically suitable for treatment with larotrectinib\n\nExclusion Criteria:\n\n* Currently enrolled in an ongoing clinical study of larotrectinib or another TRK inhibitor'}, 'identificationModule': {'nctId': 'NCT03025360', 'briefTitle': 'Expanded Access to Provide Larotrectinib for the Treatment of Cancers With a NTRK Gene Fusion', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'Expanded Access to Provide Larotrectinib (LOXO-101) for the Treatment of Cancers With a NTRK Gene Fusion', 'orgStudyIdInfo': {'id': '20366'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Larotrectinib (Vitrakvi, BAY2757556)', 'type': 'DRUG', 'otherNames': ['LOXO-101'], 'description': 'Larotrectinib will be administered orally as capsule or liquid solution as specified by the treating physician.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}