Ignite Creation Date:
2025-12-24 @ 10:29 PM
Ignite Modification Date:
2026-02-25 @ 8:27 PM
Study NCT ID:
NCT03127735
Status:
COMPLETED
Last Update Posted:
2019-05-14
First Post:
2017-04-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
BAY1436032 in Patients With Mutant IDH1(mIDH1) Advanced Acute Myeloid Leukemia (AML)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000622445', 'term': 'BAY 1436032'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2019-03-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-13', 'studyFirstSubmitDate': '2017-04-06', 'studyFirstSubmitQcDate': '2017-04-20', 'lastUpdatePostDateStruct': {'date': '2019-05-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum tolerated dose (MTD) or RP2D of BAY1436032', 'timeFrame': 'Within first 4 weeks of first dose', 'description': 'If the MTD is not reached during dose escalation, the primary variable will be the recommended phase 2 dose (RP2D) of BAY1436032'}, {'measure': 'Number of participants with Adverse Events as a Measure of', 'timeFrame': 'Up to 12 weeks', 'description': 'As a measure of safety and tolerability'}], 'secondaryOutcomes': [{'measure': 'Objective efficacy response', 'timeFrame': 'Up to 12 weeks', 'description': "Response assessment for AML in this study will be based on the modified Cheson criteria. The following categories are used to capture the investigator's AML response evaluation:\n\n* Complete remission (CR)\n* Morphologic CR with CRh (morphologic CR with incomplete hematological recovery) and the response category CRp (morphologic CR with incomplete platelet recovery)\n* Partial remission (PR)\n* Response categories for morphologic leukemia-free state (MLFS), stable disease and progressive disease\n* Progressive disease"}, {'measure': 'Duration of response', 'timeFrame': 'Up to 12 weeks', 'description': 'Efficacy data'}, {'measure': 'Event-free survival (EFS)', 'timeFrame': 'Up to 12 weeks', 'description': 'EFS defined as time from start of treatment to treatment failure, relapse, or death due to any cause.'}, {'measure': 'Change of 2 hydroxyglutarate (2-HG) level obtained at baseline and post-baseline', 'timeFrame': 'Up to 12 weeks', 'description': 'Assess pharmacodynamic (PD) effects and evidence of clinical efficacy associated with BAY 1436032 administration in patients. Change from baseline and percent change from baseline will be calculated.'}, {'measure': 'Cmax (maximum observed drug concentration in plasma after a single dose)', 'timeFrame': 'Cycle 1 Day 1: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hour post-dose (each cycle is 28 days)', 'description': 'As a secondary objective of this study evaluate the pharmacokinetics (PK) of BAY 1436032 in patients.\n\nPK parameters normalized for dose and / or dose and body weight will be calculated.'}, {'measure': 'AUC(0-8) (AUC from time 0 to 8 h after a single dose)', 'timeFrame': 'Cycle 1 Day 1: Pre-dose, 0.5, 1, 2, 3, 4, 6, and 8 hour post-dose (each cycle is 28 days)', 'description': 'As a secondary objective of this study evaluate the pharmacokinetics (PK) of BAY 1436032 in patients.\n\nPK parameters normalized for dose and / or dose and body weight will be calculated.'}, {'measure': 'AUC(0-12) (AUC from time 0 to 12 h after a single dose)', 'timeFrame': 'Cycle 1 Day 1: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12 hour post-dose (each cycle is 28 days)', 'description': 'if feasible'}, {'measure': 'Cmax,md (Cmax after multiple doses)', 'timeFrame': 'Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, and 12 hour post-dose on Day 15; (each cycle is 28 days)', 'description': 'As a secondary objective of this study evaluate the pharmacokinetics (PK) of BAY 1436032 in patients.\n\nPK parameters normalized for dose and / or dose and body weight will be calculated.'}, {'measure': 'AUC(0-8)md (AUC from time 0 to 8 h after multiple doses)', 'timeFrame': 'Pre-dose, 0.5, 1, 2, 3, 4, 6, and 8 hour post-dose on Day 15; (each cycle is 28 days)', 'description': 'As a secondary objective of this study evaluate the pharmacokinetics (PK) of BAY 1436032 in patients.\n\nPK parameters normalized for dose and / or dose and body weight will be calculated.'}, {'measure': 'AUC(0-12)md (AUC from time 0 to 12 h after multiple doses)', 'timeFrame': 'Pre-dose, 0.5, 1, 2, 3, 4, 6, and 8 hour post-dose on Day 15; (each cycle is 28 days)', 'description': 'if feasible'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Phase 1', 'mIDH1', 'IDH1 mutation', 'mIDH1 inhibitor'], 'conditions': ['Leukemia, Myeloid, Acute']}, 'descriptionModule': {'briefSummary': 'To determine the maximum tolerated and / or recommended Phase II dose of oral mutant IDH1 (mIDH1) inhibitor BAY1436032 and to characterize its safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary clinical efficacy in patients with mIDH1-R132X advanced acute myeloid leukemia (AML)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with advanced AML that harbors IDH1 mutation\n* Patients are relapsed from or refractory to at least 1 previous line of therapy\n* Good kidney and liver function\n* Male or female patients\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2\n* Women must have a negative serum pregnancy test within 7 days prior to the first dose of study drug or be surgically or biologically sterile or postmenopausal\n\nExclusion Criteria:\n\n* Previously treated with any prior mIDH1 targeted therapy\n* Extramedullary disease only\n* History of clinically significant or active cardiac disease\n* Active clinically significant infection\n* Unresolved chronic toxicity of previous AML treatment\n* Taking known strong cytochrome P450 (CYP) 2C8 inducers or inhibitors\n* Pregnancy or breast-feeding'}, 'identificationModule': {'nctId': 'NCT03127735', 'briefTitle': 'BAY1436032 in Patients With Mutant IDH1(mIDH1) Advanced Acute Myeloid Leukemia (AML)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'An Open-label, Non-randomized, Multicenter Phase I Study to Determine the Maximum Tolerated and / or Recommended Phase II Dose of Oral Mutant IDH1 (mIDH1) Inhibitor BAY1436032 and to Characterize Its Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Clinical Efficacy in Patients With mIDH1-R132X Advanced Acute Myeloid Leukemia (AML)', 'orgStudyIdInfo': {'id': '19036'}, 'secondaryIdInfos': [{'id': '2016-004095-22', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BAY1436032', 'description': 'Dose escalation:\n\nVarious doses of study drug will be tested on a small number of patients/dose with the goal of identifying the most appropriate dose(s) for further evaluation in dose expansion. The MTD of the study drug may or may not be identified. It is anticipated that 3-4 patients will be treated at each dose of study drug to be tested and that 15-20 total patients will be treated in this part of the trial.\n\nDose expansion:\n\nUp to 2 different doses of study drug will be tested on up to 30 patients/dose with the goal of identifying the most appropriate RP2D for further clinical development. The doses to be evaluated in this part of the trial will be selected based on information obtained during dose escalation.', 'interventionNames': ['Drug: BAY1436032']}], 'interventions': [{'name': 'BAY1436032', 'type': 'DRUG', 'description': 'BAY1436032 administered continuously as a single agent dosed twice a day orally on Days 1 to 28 of a 28-day cycle.\n\nPatients may continue treatment with BAY1436032 until disease progression, development of other unacceptable toxicity or Investigator discretion.', 'armGroupLabels': ['BAY1436032']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14263-0001', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'Roswell Park Comprehensive Cancer Center', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Mount Sinai Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10467-2490', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Montefiore Medical Center', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Forest Baptist Health', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ohio State University', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Thomas Jefferson University', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '69120', 'city': 'Heidelberg', 'state': 'Baden-Wurttemberg', 'country': 'Germany', 'facility': 'Universitätsklinikum Heidelberg', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}, {'zip': '30625', 'city': 'Hanover', 'state': 'Lower Saxony', 'country': 'Germany', 'facility': 'Medizinische Hochschule Hannover (MHH)', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'city': 'Leipzig', 'state': 'Saxony', 'country': 'Germany', 'facility': 'Universitätsklinikum Leipzig AöR', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}, {'zip': '12200', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Universitätsklinikum Charite zu Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '20246', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'Universitätsklinikum Hamburg Eppendorf (UKE)', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}