Ignite Creation Date:
2025-12-24 @ 4:37 PM
Ignite Modification Date:
2025-12-29 @ 8:05 AM
Study NCT ID:
NCT05219266
Status:
NO_LONGER_AVAILABLE
Last Update Posted:
2024-06-28
First Post:
2021-10-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Managed Access Programs for PKC412, Midostaurin
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}, {'id': 'D034721', 'term': 'Mastocytosis, Systemic'}, {'id': 'D007946', 'term': 'Leukemia, Mast-Cell'}], 'ancestors': [{'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D008415', 'term': 'Mastocytosis'}, {'id': 'D009372', 'term': 'Neoplasms, Connective Tissue'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D000090362', 'term': 'Mast Cell Activation Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C059539', 'term': 'midostaurin'}]}}, 'protocolSection': {'designModule': {'studyType': 'EXPANDED_ACCESS', 'expandedAccessTypes': {'intermediate': True}, 'nPtrsToThisExpAccNctId': 1}, 'statusModule': {'overallStatus': 'NO_LONGER_AVAILABLE', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'lastUpdateSubmitDate': '2024-06-27', 'studyFirstSubmitDate': '2021-10-05', 'studyFirstSubmitQcDate': '2022-02-01', 'lastUpdatePostDateStruct': {'date': '2024-06-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-02', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['FLT3-mutated AML', 'AML', 'Aggressive systemic mastocytosis', 'Mast cell leukemia', 'Systemic mastocytosis with an associated hematologic neoplasm', 'MAP', 'Manage access program', 'PKC412', 'Midostaurin'], 'conditions': ['FMS-Like Tyrosine Kinase 3 (FLT3)-Mutated Acute Myeloid Leukemia', 'Acute Myeloid Leukemia', 'Aggressive Systemic Mastocytosis', 'Mast Cell Leukemia', 'Systemic Mastocytosis With an Associated Hematologic Neoplasm']}, 'descriptionModule': {'briefSummary': 'The purpose of this registration is to list Managed Access Programs (MAPs) related to PKC4, Midostaurin.', 'detailedDescription': '* CPKC412A2001X - No longer available- An open-labeled, multi-center, Expanded Treatment Protocol (ETP) of midostaurin (PKC412) in patients 18 years of age or older with newly-diagnosed FLT3-mutated acute myeloid leukemia (AML) who are eligible for standard induction and consolidation chemotherapy\n* CPKC412AUS56X - No longer available - An open-label, multi-center, Expanded Treatment Protocol of Midostaurin (PKC412) in adult patients with newly diagnosed Fms-like tyrosine kinase receptor (FLT3) mutated Acute Myeloid Leukemia (AML) who are eligible for standard induction and consolidation chemotherapy.\n* CPKC412A2407I - No longer available- Managed Access Program (MAP) Cohort Treatment Plan CPKC412A2407I to provide access to midostaurin (PKC412) for patients 18 years of age and older with newly-diagnosed FLT3-mutated AML and eligible for induction and consolidation chemotherapy\n* CPKC412D2001M - No longer available- Managed Access Program (MAP) to provide access to Midostaurin (PKC412), for an individual patient with aggressive systemic mastocytosis (ASM), mast cell leukemia (MCL) or mast cell sarcoma (MCS)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* An independent request should be received from a licensed physician (in some instances from Health Authorities, Institutions or Governments).\n* The patient has a serious or life-threatening disease or condition and no comparable or satisfactory alternative therapy is available for diagnosis, monitoring or treatment; patient is not medically eligible for available treatment alternatives or has exhausted all available treatment options.\n* The patient is not eligible or able to enroll in a Novartis clinical trial or continue participation in a Novartis clinical trial.\n* There is a potential patient benefit to justify the potential risk of the treatment use, and the potential risk is not unreasonable in the context of the disease or condition to be treated.\n* The patient must meet any other medical criteria established by the medical experts responsible for the product or by the Health Authority in a country (as applicable).\n* Provision of the product will not interfere with the initiation, conduct or completion of a Novartis clinical trial or overall development program.\n* Managed access provision is allowed per local laws/regulations.'}, 'identificationModule': {'nctId': 'NCT05219266', 'briefTitle': 'Managed Access Programs for PKC412, Midostaurin', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'Managed Access Programs for PKC412, Midostaurin', 'orgStudyIdInfo': {'id': 'CPKC412A2407I'}}, 'armsInterventionsModule': {'interventions': [{'name': 'midostaurin', 'type': 'DRUG', 'otherNames': ['PKC412'], 'description': 'Patients receive midostaurin'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}