Ignite Creation Date:
2025-12-25 @ 2:59 AM
Ignite Modification Date:
2025-12-31 @ 8:59 AM
Study NCT ID:
NCT04809233
Status:
AVAILABLE
Last Update Posted:
2025-06-04
First Post:
2021-03-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Expanded Access to Tipifarnib
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016411', 'term': 'Lymphoma, T-Cell, Peripheral'}, {'id': 'D008223', 'term': 'Lymphoma'}], 'ancestors': [{'id': 'D016399', 'term': 'Lymphoma, T-Cell'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C402769', 'term': 'tipifarnib'}]}}, 'protocolSection': {'designModule': {'studyType': 'EXPANDED_ACCESS', 'expandedAccessTypes': {'individual': True}, 'nPtrsToThisExpAccNctId': 3}, 'statusModule': {'overallStatus': 'AVAILABLE', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'lastUpdateSubmitDate': '2025-05-29', 'studyFirstSubmitDate': '2021-03-18', 'studyFirstSubmitQcDate': '2021-03-18', 'lastUpdatePostDateStruct': {'date': '2025-06-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-22', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['Lymphoma', 'T-Cell', 'Peripheral', 'Non-Hodgkin', 'HRAS', 'Peripheral T-cell'], 'conditions': ['HRAS Mutations or Peripheral T Cell Lymphoma (PTCL)']}, 'descriptionModule': {'briefSummary': 'Requests for single patient expanded access to tipifarnib may be considered for adult patients with HRAS mutations or peripheral T Cell Lymphoma (PTCL).\n\nTo request access, use Responsible Party contact information provided in this record.\n\nExpanded access for tipifarnib is only available in the United States.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'eligibilityCriteria': 'Inclusion/Exclusion Criteria:\n\nDiagnosed with HRAS-mutant carcinomas or peripheral T Cell Lymphoma (PTCL).\n\nAdult, ages 18+.\n\nHave exhausted appropriate standard treatments without success and no comparable or satisfactory alternative treatment is available or exists to treat the disease or condition.\n\nIs ineligible for participation in any ongoing clinical study of the investigational drug, which includes lack of access due to geographic limitations.\n\nMeets any other pertinent medical criteria for access to the investigational drug, as established by the Kura Oncology'}, 'identificationModule': {'nctId': 'NCT04809233', 'briefTitle': 'Expanded Access to Tipifarnib', 'organization': {'class': 'INDUSTRY', 'fullName': 'Kura Oncology, Inc.'}, 'orgStudyIdInfo': {'id': 'Expanded Access to Tipifarnib'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Tipifarnib', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Clinical Operations', 'role': 'CONTACT', 'email': 'ExpandedAccess@kuraoncology.com', 'phone': '617-588-3755'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kura Oncology, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}