Ignite Creation Date:
2025-12-24 @ 11:58 PM
Ignite Modification Date:
2026-01-07 @ 6:28 AM
Study NCT ID:
NCT03361358
Status:
COMPLETED
Last Update Posted:
2020-03-16
First Post:
2017-11-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pre-Screening Study to Identify MTAP Loss in Advanced Solid Tumors or Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['France']}, 'conditionBrowseModule': {'meshes': [{'id': 'D008223', 'term': 'Lymphoma'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Archived tumor samples will be collected and stored for an unlimited amount of time.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2019-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-13', 'studyFirstSubmitDate': '2017-11-16', 'studyFirstSubmitQcDate': '2017-11-28', 'lastUpdatePostDateStruct': {'date': '2020-03-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determination of MTAP status in tumors', 'timeFrame': 'From initiation of the Pre-Screen study until the Phase 1 study of AG-270 is activated at each study site, up to 9 months', 'description': 'Number of tumor tissue samples found to have or not have MTAP deletion, as assessed by IHC'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Advanced Solid Tumors', 'Lymphoma']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to identify subjects with advanced solid tumors or lymphoma in which the methylthioadenosine phosphorylase (MTAP) protein has been lost.', 'detailedDescription': 'Study AG270-PS-001 is a pre-screening study to identify subjects with advanced solid tumors or lymphoma in which the MTAP protein has been lost. Subjects whose tumor tissue has lost the MTAP protein may be considered for future enrollment into a Phase 1 clinical study of an experimental drug, AG-270, that is designed to inhibit the growth of tumors lacking this protein.\n\nIdentification of the loss of MTAP will rely solely on the evaluation of archival tumor tissue samples by IHC. This study is therefore non-interventional'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Subjects appropriate for this study will be identified by the Investigators at the study sites based on their clinical judgment. This study may be conducted in subjects who are not currently eligible for an experimental therapy, recognizing that determination of the tumor's MTAP status could be useful in making future decisions about options for treatment.", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Be ≥18 years of age.\n2. Have a histologically confirmed diagnosis of an advanced solid tumor (other than a primary CNS malignancy) or lymphoma.\n3. Have archival tumor tissue that can be provided for assessment of MTAP deletion status.\n4. Have given written informed consent to participate in this study.\n\nExclusion Criteria:\n\n1. Have a primary CNS malignancy (eg, GBM).\n2. Have a medical or psychological condition deemed by the Investigator likely to interfere with the subject's ability to give informed consent or participate in the study."}, 'identificationModule': {'nctId': 'NCT03361358', 'briefTitle': 'Pre-Screening Study to Identify MTAP Loss in Advanced Solid Tumors or Lymphoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Agios Pharmaceuticals, Inc.'}, 'officialTitle': 'Identification of MTAP Deletion in Archival Tumor Tissue: A Pre-Screening Study in Subjects With Advanced Solid Tumors or Lymphoma', 'orgStudyIdInfo': {'id': 'AG270-PS-001'}}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Boston, MA', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Nashville, TN', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '08035', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Barcelona, Spain', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Agios Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}