Ignite Creation Date:
2025-12-25 @ 4:41 AM
Ignite Modification Date:
2026-03-05 @ 4:55 PM
Study NCT ID:
NCT03620318
Status:
AVAILABLE
Last Update Posted:
2024-08-09
First Post:
2018-08-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Individual Patient Compassionate Use of Crenolanib
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'EXPANDED_ACCESS', 'expandedAccessTypes': {'individual': True}}, 'statusModule': {'overallStatus': 'AVAILABLE', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'lastUpdateSubmitDate': '2024-08-07', 'studyFirstSubmitDate': '2018-08-02', 'studyFirstSubmitQcDate': '2018-08-07', 'lastUpdatePostDateStruct': {'date': '2024-08-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-08', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['Compassionate use'], 'conditions': ['FLT3-ITD Mutation', 'FLT3/TKD Mutation', 'PDGFR-Alpha D842V', 'PDGFRA Gene Amplification']}, 'descriptionModule': {'briefSummary': 'Compassionate use of crenolanib for patients with serious life-threatening illness that have exhausted all available therapies used to treat the disease, with no other viable therapy options, who is not eligible for clinical trials. This program is designed to evaluate the requests on a patient by patient basis.\n\nPatients must have documented evidence of a point mutation in position 842 in platelet derived growth factor receptor alpha (PDGFRA-D842V) or amplification of PDGFRA or internal tandem duplication within the FMS-like tyrosine kinase 3 (FLT3-ITD) or point mutations within the tyrosine kinase domain (TKD) of FLT3 (FLT3-TKD)', 'detailedDescription': 'This program is being offered on a patient by patient basis while phase 3 studies with crenolanib are ongoing.\n\nInstitutional Review Board-/Independent Ethics Committee approval must be granted before, The experimental intervention will be administered over 28-day cycles. Compassionate use of crenolanib will be limited such that it does not interfere with the supply need for phase 3 studies.\n\nThere must be adequate understanding of the indication for the requested use.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subject must have a serious life threatening cancer with FLT3/PDGFRa mutation or PDGFRa amplification who has exhausted all other treatment options\n* Subject and their partner (if adults) must use 2 forms of contraception during study and for 3 months following last dose of study drug\n\nExclusion Criteria:\n\n* Subject is eligible for enrollment in an ongoing clinical trial\n* Subject has any condition which, in the investigator's opinion makes the subject unsuitable for participation"}, 'identificationModule': {'nctId': 'NCT03620318', 'briefTitle': 'Individual Patient Compassionate Use of Crenolanib', 'organization': {'class': 'INDUSTRY', 'fullName': 'Arog Pharmaceuticals, Inc.'}, 'officialTitle': 'Compassionate Use of Crenolanib for Cancers With Platelet Derived Growth Factor Receptor Alpha (PDGFRa) Mutations, PDGFRa Amplifications or Fms-like Tyrosine Kinase 3 (FLT3) Mutations', 'orgStudyIdInfo': {'id': 'ARO-EAP'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Crenolanib besylate', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Genova', 'status': 'AVAILABLE', 'country': 'Italy', 'contacts': [{'name': 'Emanuele Angelucci, MD', 'role': 'CONTACT'}], 'facility': 'Ospedale Policlinico San Martino', 'geoPoint': {'lat': 45.21604, 'lon': 11.87211}}], 'centralContacts': [{'name': 'Vinay Jain, MD', 'role': 'CONTACT', 'email': 'info@arogpharma.com', 'phone': '214-593-0500'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Arog Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}