Ignite Creation Date:
2025-12-24 @ 12:13 PM
Ignite Modification Date:
2026-04-15 @ 5:36 PM
Study NCT ID:
NCT03066661
Status:
NO_LONGER_AVAILABLE
Last Update Posted:
2019-04-26
First Post:
2017-02-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Expanded Access to Entrectinib for Cancers With NTRK1/2/3, ROS1, or ALK Gene Fusions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000607349', 'term': 'entrectinib'}]}}, 'protocolSection': {'designModule': {'studyType': 'EXPANDED_ACCESS', 'nPtrsToThisExpAccNctId': 1}, 'statusModule': {'overallStatus': 'NO_LONGER_AVAILABLE', 'statusVerifiedDate': '2019-04', 'lastUpdateSubmitDate': '2019-04-24', 'studyFirstSubmitDate': '2017-02-23', 'studyFirstSubmitQcDate': '2017-02-23', 'lastUpdatePostDateStruct': {'date': '2019-04-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-02-28', 'type': 'ACTUAL'}}, 'conditionsModule': {'conditions': ['Cancers With NTRK, ROS1, or ALK Gene Fusions']}, 'descriptionModule': {'briefSummary': 'Expanded access to entrectinib will be given to patients with cancers harboring NTRK1/2/3, ROS1, or ALK gene fusions who do not qualify for participation in, or who are otherwise unable to access, an ongoing clinical trial for entrectinib.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of advanced cancer with an NTRK1, NTRK2, NTRK3, ROS1, or ALK gene fusion\n* Unable to participate in an ongoing entrectinib (RXDX-101) clinical trial\n* Willing and able to provide written, signed informed consent\n* Medically suitable for treatment with entrectinib (RXDX-101)\n\nExclusion Criteria:\n\n* Currently enrolled in an ongoing clinical study with any other investigational agent'}, 'identificationModule': {'nctId': 'NCT03066661', 'briefTitle': 'Expanded Access to Entrectinib for Cancers With NTRK1/2/3, ROS1, or ALK Gene Fusions', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'Expanded Access to Entrectinib (RXDX-101) for the Treatment of Cancers With NTRK, ROS1, or ALK Gene Fusions', 'orgStudyIdInfo': {'id': 'Entrectinib (RXDX-101) - EAP'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Entrectinib', 'type': 'DRUG', 'otherNames': ['RXDX-101'], 'description': 'Open-label expanded access, capsules'}]}, 'contactsLocationsModule': {'locations': [{'zip': '92121', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': '1-844-Startrk (782-7875)', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}