Ignite Creation Date:
2025-12-24 @ 9:57 PM
Ignite Modification Date:
2025-12-25 @ 7:35 PM
Study NCT ID:
NCT07215832
Status:
AVAILABLE
Last Update Posted:
2025-10-14
First Post:
2025-09-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Karyopharm Expanded Access Program for Selinexor
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009101', 'term': 'Multiple Myeloma'}, {'id': 'D016403', 'term': 'Lymphoma, Large B-Cell, Diffuse'}, {'id': 'D012509', 'term': 'Sarcoma'}, {'id': 'D016411', 'term': 'Lymphoma, T-Cell, Peripheral'}, {'id': 'D016889', 'term': 'Endometrial Neoplasms'}, {'id': 'D055728', 'term': 'Primary Myelofibrosis'}], 'ancestors': [{'id': 'D054219', 'term': 'Neoplasms, Plasma Cell'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D020141', 'term': 'Hemostatic Disorders'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010265', 'term': 'Paraproteinemias'}, {'id': 'D001796', 'term': 'Blood Protein Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D016393', 'term': 'Lymphoma, B-Cell'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D016399', 'term': 'Lymphoma, T-Cell'}, {'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D009196', 'term': 'Myeloproliferative Disorders'}, {'id': 'D001855', 'term': 'Bone Marrow Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C585161', 'term': 'selinexor'}]}}, 'protocolSection': {'designModule': {'studyType': 'EXPANDED_ACCESS', 'expandedAccessTypes': {'individual': True}}, 'statusModule': {'overallStatus': 'AVAILABLE', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'lastUpdateSubmitDate': '2025-10-10', 'studyFirstSubmitDate': '2025-09-30', 'studyFirstSubmitQcDate': '2025-10-10', 'lastUpdatePostDateStruct': {'date': '2025-10-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-14', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['selinexor'], 'conditions': ['Multiple Myeloma', 'Diffuse Large B-Cell Lymphoma (DLBCL)', 'Sarcoma', 'Neuroglioblastoma', 'Peripheral T-cell Lymphoma', 'Endometrial Cancer', 'Myelofibrosis', 'Other']}, 'descriptionModule': {'briefSummary': "KEAP is an expanded access program designed to provide selinexor to eligible participants outside of a clinical trial before the drug has been given marketing approval by the country's regulatory agency or the drug is commercially available in the country. Patients who do not qualify for an ongoing clinical trial but who might benefit from the investigational medicine may be eligible, provided they have exhausted all other available treatment options. Investigational medicines are provided to patients only through treating physicians who obtain the relevant approval on behalf of their patient from the relevant regulatory agency and follow all applicable safety-reporting regulations of the respective country."}, 'eligibilityModule': {'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\-\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT07215832', 'acronym': 'KEAP', 'briefTitle': 'Karyopharm Expanded Access Program for Selinexor', 'organization': {'class': 'INDUSTRY', 'fullName': 'Karyopharm Therapeutics Inc'}, 'officialTitle': 'Karyopharm Expanded Access Program for Selinexor', 'orgStudyIdInfo': {'id': 'KEAP-KPT-330'}}, 'armsInterventionsModule': {'interventions': [{'name': 'selinexor', 'type': 'DRUG', 'otherNames': ['KPT-330']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Karyopharm Medical Information', 'role': 'CONTACT', 'email': 'keap.admin@karyopharm.com', 'phone': '(888) 209-9326'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karyopharm Therapeutics Inc', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Caligor Coghlan (CalCog)', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}