Ignite Creation Date:
2025-12-24 @ 7:44 PM
Ignite Modification Date:
2025-12-25 @ 5:22 PM
Study NCT ID:
NCT04507503
Status:
APPROVED_FOR_MARKETING
Last Update Posted:
2025-01-07
First Post:
2020-08-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Expanded Access Study of TAS-120 in Patients With Advanced Cholangiocarcinoma Harboring FGFR2 Gene Rearrangements
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018281', 'term': 'Cholangiocarcinoma'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000713257', 'term': 'futibatinib'}]}}, 'protocolSection': {'designModule': {'studyType': 'EXPANDED_ACCESS', 'expandedAccessTypes': {'treatment': True}, 'nPtrsToThisExpAccNctId': 3}, 'statusModule': {'overallStatus': 'APPROVED_FOR_MARKETING', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'lastUpdateSubmitDate': '2025-01-05', 'studyFirstSubmitDate': '2020-08-07', 'studyFirstSubmitQcDate': '2020-08-07', 'lastUpdatePostDateStruct': {'date': '2025-01-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-11', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['Cholangiocarcinoma', 'CCA', 'FGFR2 Gene Rearrangements', 'TAS-120', 'Futibatinib'], 'conditions': ['Advanced Cholangiocarcinoma']}, 'descriptionModule': {'briefSummary': 'The objective of the study is to provide access to TAS-120 to patients With Advanced Cholangiocarcinoma Harboring FGFR2 Gene Rearrangements.', 'detailedDescription': 'This is an open-label study to provide expanded access to TAS-120 prior to its commercial availability for patients with Advanced Cholangiocarcinoma Harboring FGFR2 Gene Rearrangements who have failed standard therapy or who are unable to tolerate standard therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Provide written informed consent.\n2. \\>18 years of age.\n3. Histologically confirmed, locally advanced, or metastatic, or recurrent unresectable CCA harboring FGFR2 gene rearrangements based on testing performed by a qualified (CLIA-certified) laboratory.\n4. Patient has failed standard therapy or standard therapy is not tolerated.\n5. Has measurable or non-measurable lesion(s).\n6. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.\n7. Adequate organ function.\n\nExclusion Criteria:\n\n1. History and/or current evidence of non-tumor related alteration of calcium-phosphorus homeostasis.\n2. History and/or current evidence of clinically significant ectopic mineralization/calcification.\n3. History and/or current evidence of clinically significant retinal disorder confirmed by retinal examination.\n4. A serious illness or medical condition(s)\n5. Pregnant or breast-feeding female'}, 'identificationModule': {'nctId': 'NCT04507503', 'briefTitle': 'Expanded Access Study of TAS-120 in Patients With Advanced Cholangiocarcinoma Harboring FGFR2 Gene Rearrangements', 'organization': {'class': 'INDUSTRY', 'fullName': 'Taiho Oncology, Inc.'}, 'officialTitle': 'An Open-Label Expanded Access Program of Futibatinib (TAS-120) In Patients With Advanced Cholangiocarcinoma Harboring FGFR2 Gene Rearrangements', 'orgStudyIdInfo': {'id': 'TAS-120-401'}}, 'armsInterventionsModule': {'interventions': [{'name': 'TAS-120', 'type': 'DRUG', 'otherNames': ['Futibatinib'], 'description': 'Futibatinib 20mg QD orally on a 28 days cycle'}]}, 'contactsLocationsModule': {'locations': [{'zip': '85234', 'city': 'Gilbert', 'state': 'Arizona', 'country': 'United States', 'facility': 'Banner MD Anderson', 'geoPoint': {'lat': 33.35283, 'lon': -111.78903}}, {'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California, San Francisco (UCSF)', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '90404', 'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'facility': 'UCLA Division of Hematology-Oncology', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}, {'zip': '33140', 'city': 'Miami Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Mount Sinai Center of Florida', 'geoPoint': {'lat': 25.79065, 'lon': -80.13005}}, {'zip': '32804', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Advent Health Orlando', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '21231', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Dana Farber Cancer Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '64064', 'city': "Lee's Summit", 'state': 'Missouri', 'country': 'United States', 'facility': 'University of Kansas Cancer Center', 'geoPoint': {'lat': 38.91084, 'lon': -94.38217}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '97213', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Providence Portland Medical Center', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'MD Anderson', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '84106', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Utah Cancer Specialists', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '98109', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Seattle Cancer Care Alliance', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '53024', 'city': 'Grafton', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Aurora Cancer care', 'geoPoint': {'lat': 43.31973, 'lon': -87.95342}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taiho Oncology, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}