Ignite Creation Date:
2025-12-24 @ 4:05 PM
Ignite Modification Date:
2025-12-28 @ 11:12 AM
Study NCT ID:
NCT06915766
Status:
AVAILABLE
Last Update Posted:
2025-11-05
First Post:
2025-03-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Expanded Access to Bezuclastinib for Patients With NonAdvanced Systemic Mastocytosis or Advanced Systemic Mastocytosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D034721', 'term': 'Mastocytosis, Systemic'}, {'id': 'D007946', 'term': 'Leukemia, Mast-Cell'}], 'ancestors': [{'id': 'D008415', 'term': 'Mastocytosis'}, {'id': 'D009372', 'term': 'Neoplasms, Connective Tissue'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D000090362', 'term': 'Mast Cell Activation Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}, {'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'EXPANDED_ACCESS', 'expandedAccessTypes': {'intermediate': True}}, 'statusModule': {'overallStatus': 'AVAILABLE', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'lastUpdateSubmitDate': '2025-11-04', 'studyFirstSubmitDate': '2025-03-31', 'studyFirstSubmitQcDate': '2025-03-31', 'lastUpdatePostDateStruct': {'date': '2025-11-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-04-08', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['Systemic Mastocytosis', 'NonAdvanced Systemic Mastocytosis', 'Advanced Systemic Mastocytosis', 'Systemic Mastocytosis with an associated hematologic neoplasm (SM-AHN)', 'Aggressive Systemic Mastocytosis (ASM)', 'Mast Cell Leukemia (MCL)', 'Bone Marrow Mastocytosis (BMM)'], 'conditions': ['Systemic Mastocytoses, Indolent', 'Systemic Mastocytoses, Aggressive']}, 'descriptionModule': {'briefSummary': 'The purpose of this expanded access program (EAP) protocol is to provide investigational bezuclastinib to patients with a diagnosis of nonadvanced systemic mastocytosis (NonAdvSM) or advanced systemic mastocytosis (AdvSM) who have received and failed or been intolerant to at least one standard approved therapy and/or have no comparable or satisfactory alternative therapy options.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Able to provide written informed consent and commit to EAP assessments.\n* ≥18 years of age.\n* Able to swallow tablets.\n* Diagnosed with ASM, SM-AHN, MCL, BMM, ISM, or SSM according to the 2022 WHO Classification for SM\n* Not receiving adequate disease control on current therapy(ies).\n* Have clinically acceptable laboratory screening results.\n\nExclusion Criteria:\n\n* Patients who are eligible for and/or enrolled in an on-going bezuclastinib clinical trial.\n* Patients who discontinued investigational use of bezuclastinib in previous clinical trials due to toxicity or withdrawal of consent.\n* Pregnant or currently breastfeeding.\n* Prior or ongoing clinically significant illness or medical or physical condition\n\nOther protocol-defined criteria apply.'}, 'identificationModule': {'nctId': 'NCT06915766', 'briefTitle': 'Expanded Access to Bezuclastinib for Patients With NonAdvanced Systemic Mastocytosis or Advanced Systemic Mastocytosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cogent Biosciences, Inc.'}, 'officialTitle': 'Intermediate-Size Patient Population Expanded Access to Bezuclastinib for Patients With NonAdvanced Systemic Mastocytosis or Advanced Systemic Mastocytosis', 'orgStudyIdInfo': {'id': 'CGT9486-IEAP-001'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Bezuclastinib', 'type': 'DRUG', 'otherNames': ['CGT9486'], 'description': 'Drug: Bezuclastinib Tablets'}]}, 'contactsLocationsModule': {'locations': [{'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'status': 'AVAILABLE', 'country': 'United States', 'contacts': [{'name': 'Allyson Cyr', 'role': 'CONTACT', 'email': 'acyr@orso-health.com', 'phone': '858-260-2977'}, {'name': 'Brian Modena, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Orso Health/Modena Asthma Allergy', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'status': 'AVAILABLE', 'country': 'United States', 'contacts': [{'name': 'Craig Sewell, DO', 'role': 'CONTACT', 'email': 'cdsewell@iu.edu'}], 'facility': 'Indiana University Health', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '20889', 'city': 'Bethesda', 'state': 'Maryland', 'status': 'AVAILABLE', 'country': 'United States', 'contacts': [{'name': 'Nathan Boggs, MD, PhD', 'role': 'CONTACT', 'email': 'nathan.boggs@usuhs.edu'}], 'facility': 'Walter Reed', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}, {'zip': '20769', 'city': 'Glenn Dale', 'state': 'Maryland', 'status': 'AVAILABLE', 'country': 'United States', 'contacts': [{'name': 'Arnold Kirshenbaum, MD', 'role': 'CONTACT', 'email': 'akirshenbaum@allervie.com'}], 'facility': 'AllerVie Health', 'geoPoint': {'lat': 38.98761, 'lon': -76.82053}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'AVAILABLE', 'country': 'United States', 'contacts': [{'name': 'Morgan Vitale', 'role': 'CONTACT', 'email': 'Morgan_vitale@dfci.harvard.edu'}], 'facility': 'Dana Farber Cancer Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '03756', 'city': 'Lebanon', 'state': 'New Hampshire', 'status': 'AVAILABLE', 'country': 'United States', 'contacts': [{'name': 'Frederick Lansigan, MD', 'role': 'CONTACT', 'email': 'frederick.lansigan@hitchcock.org', 'phone': '603-650-4628'}, {'name': 'Frederick Lansigan, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Dartmouth-Hitchcock Medical Center', 'geoPoint': {'lat': 43.64229, 'lon': -72.25176}}, {'zip': '27705', 'city': 'Durham', 'state': 'North Carolina', 'status': 'AVAILABLE', 'country': 'United States', 'contacts': [{'name': 'Sherry Huber, RN, BSN', 'role': 'CONTACT', 'email': 'sherry.huber@duke.edu'}], 'facility': 'Duke Blood Cancer Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'status': 'AVAILABLE', 'country': 'United States', 'contacts': [{'name': 'Jennifer Vaughn, MD', 'role': 'CONTACT', 'email': 'jennifer.vaughn2@osumc.edu'}], 'facility': 'The Ohio State University Wexner Medical Center', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '75231', 'city': 'Dallas', 'state': 'Texas', 'status': 'AVAILABLE', 'country': 'United States', 'contacts': [{'name': 'Lucinda Van Anglen', 'role': 'CONTACT', 'email': 'lvananglen@healix.net'}], 'facility': 'AIR Care', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'AVAILABLE', 'country': 'United States', 'contacts': [{'name': 'Shareen Gopal', 'role': 'CONTACT', 'email': 'sgopal@mdanderson.org'}], 'facility': 'The University of Texas, MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'centralContacts': [{'name': 'Alexandra Malinowski, PharmD', 'role': 'CONTACT', 'email': 'medinfo@cogentbio.com', 'phone': '1-877-633-8049'}], 'overallOfficials': [{'name': 'Rachael Easton, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cogent Biosciences, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cogent Biosciences, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}