Ignite Creation Date:
2025-12-24 @ 4:20 PM
Ignite Modification Date:
2025-12-28 @ 2:16 AM
Study NCT ID:
NCT05028166
Status:
AVAILABLE
Last Update Posted:
2024-03-15
First Post:
2021-08-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Individual Patient Compassionate Use of Mirdametinib
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017253', 'term': 'Neurofibromatoses'}, {'id': 'D018318', 'term': 'Neurofibroma, Plexiform'}], 'ancestors': [{'id': 'D009455', 'term': 'Neurofibroma'}, {'id': 'D018317', 'term': 'Nerve Sheath Neoplasms'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009386', 'term': 'Neoplastic Syndromes, Hereditary'}, {'id': 'D020752', 'term': 'Neurocutaneous Syndromes'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020271', 'term': 'Heredodegenerative Disorders, Nervous System'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D010524', 'term': 'Peripheral Nervous System Neoplasms'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C506614', 'term': 'mirdametinib'}]}}, 'protocolSection': {'designModule': {'studyType': 'EXPANDED_ACCESS', 'expandedAccessTypes': {'individual': True}, 'nPtrsToThisExpAccNctId': 1}, 'statusModule': {'overallStatus': 'AVAILABLE', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'lastUpdateSubmitDate': '2024-03-13', 'studyFirstSubmitDate': '2021-08-24', 'studyFirstSubmitQcDate': '2021-08-24', 'lastUpdatePostDateStruct': {'date': '2024-03-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-31', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['RASopathies', 'NF1', 'Neurofibromatosis', 'Plexiform Neurofibromas', 'Langerhans'], 'conditions': ['Neurofibromatosis Type 1-Associated Plexiform Neurofibromas', 'Histiocytic Neoplasm', 'Other MAP-K Pathway Driven Diseases']}, 'descriptionModule': {'briefSummary': 'This program is being offered on a patient by patient basis and will require company, Institutional Review Board/Independent Ethics Committee, and applicable competent authority approval.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '2 Years', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient has a serious, debilitating or life-threatening medical condition that cannot be treated satisfactorily with an authorized medicinal product or other available standard treatment options, or all other treatment options have been exhausted.\n* Patient does not qualify to participate in an ongoing clinical trial.'}, 'identificationModule': {'nctId': 'NCT05028166', 'briefTitle': 'Individual Patient Compassionate Use of Mirdametinib', 'organization': {'class': 'INDUSTRY', 'fullName': 'SpringWorks Therapeutics, Inc.'}, 'orgStudyIdInfo': {'id': 'MEK-NF1-701'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Mirdametinib (MEK Inhibitor)', 'type': 'DRUG', 'description': 'Patients will receive oral mirdametinib.'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'SpringWorks Medical Information', 'role': 'CONTACT', 'email': 'medinfo@springworkstx.com', 'phone': '(888) 400-7989'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'SpringWorks Therapeutics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}