Ignite Creation Date:
2025-12-24 @ 10:46 PM
Ignite Modification Date:
2026-03-01 @ 5:17 PM
Study NCT ID:
NCT03052569
Status:
NO_LONGER_AVAILABLE
Last Update Posted:
2019-04-26
First Post:
2017-02-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Expanded Access to RXDX-105 for Cancers With RET Alterations
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C575620', 'term': 'agerafenib'}]}}, 'protocolSection': {'designModule': {'studyType': 'EXPANDED_ACCESS'}, 'statusModule': {'overallStatus': 'NO_LONGER_AVAILABLE', 'statusVerifiedDate': '2019-04', 'lastUpdateSubmitDate': '2019-04-24', 'studyFirstSubmitDate': '2017-02-10', 'studyFirstSubmitQcDate': '2017-02-10', 'lastUpdatePostDateStruct': {'date': '2019-04-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-02-14', 'type': 'ACTUAL'}}, 'conditionsModule': {'conditions': ['Cancers With RET Alterations']}, 'descriptionModule': {'briefSummary': 'Expanded access to RXDX-105 will be given to patients with cancers harboring RET alterations who have not received TKIs that target RET alterations, who do not qualify for participation in, or who are otherwise unable to access, an ongoing clinical trial for RXDX-105.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of advanced cancer with RET alterations\n* Unable to participate in an ongoing RXDX-105 clinical trial\n* Willing and able to provide written, signed informed consent\n* Medically suitable for treatment with RXDX-105\n\nExclusion Criteria:\n\n* Prior treatment with a TKI that has activity against RET alterations\n* Currently enrolled in an ongoing clinical study with any other investigational agent'}, 'identificationModule': {'nctId': 'NCT03052569', 'briefTitle': 'Expanded Access to RXDX-105 for Cancers With RET Alterations', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'Expanded Access to RXDX-105 for the Treatment of Cancers With RET Alterations', 'orgStudyIdInfo': {'id': 'RXDX-105 - EAP'}}, 'armsInterventionsModule': {'interventions': [{'name': 'RXDX-105', 'type': 'DRUG', 'description': 'Oral Capsules'}]}, 'contactsLocationsModule': {'locations': [{'zip': '92121', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Www.Ignyta.Com', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}