Ignite Creation Date:
2025-12-25 @ 4:39 AM
Ignite Modification Date:
2025-12-26 @ 3:42 AM
Study NCT ID:
NCT04965818
Status:
TERMINATED
Last Update Posted:
2024-09-19
First Post:
2021-07-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Phase 1b/2 Study of Futibatinib in Combination With Binimetinib in Patients With Advanced KRAS Mutant Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000713257', 'term': 'futibatinib'}, {'id': 'C581313', 'term': 'binimetinib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}}, 'statusModule': {'whyStopped': 'Strategic decision by sponsor.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-09-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2023-09-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-06', 'studyFirstSubmitDate': '2021-07-06', 'studyFirstSubmitQcDate': '2021-07-14', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recommended Phase 2 Dose (RP2D) in Part 1', 'timeFrame': '12 months', 'description': 'Determine RP2D of futibatinib in combination with binimetinib based on Dose Limiting Toxicities'}, {'measure': 'Objective Response Rate (ORR) in Part 2', 'timeFrame': 'approximately 24 months', 'description': 'proportion of patients who have achieved a PR or complete response (CR) according to RECIST 1.1.'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetics (PK): Maximum plasma concentration (Cmax) of futibatinib, binimetinib, and AR00426032', 'timeFrame': 'approximately 24 months', 'description': 'Plasma concentrations of futibatinib, binimetinib, and AR00426032'}, {'measure': 'PK: Area under the plasma concentration-time curve (AUC) of futibatinib, binimetinib, and AR00426032', 'timeFrame': 'approximately 24 months', 'description': 'Plasma concentrations of futibatinib, binimetinib, and AR00426032'}, {'measure': 'PK: Time to reach maximum plasma concentration (Tmax) of futibatinib, binimetinib, and AR00426032', 'timeFrame': 'approximately 24 months', 'description': 'Plasma concentrations of futibatinib, binimetinib, and AR00426032'}, {'measure': 'PK: Terminal elimination half-life (T1/2) of futibatinib, binimetinib, and AR00426032', 'timeFrame': 'approximately 24 months', 'description': 'Plasma concentrations of futibatinib, binimetinib, and AR00426032'}, {'measure': 'PK: Minimum plasma concentration before administration (Cmin) of futibatinib, binimetinib, and AR00426032', 'timeFrame': 'approximately 24 months', 'description': 'Plasma concentrations of futibatinib, binimetinib, and AR00426032'}, {'measure': 'PK: Accumulation ratio of Cmax and AUC (R) of futibatinib, binimetinib, and AR00426032', 'timeFrame': 'approximately 24 months', 'description': 'Plasma concentrations of futibatinib, binimetinib, and AR00426032'}, {'measure': 'Duration of response (DOR)', 'timeFrame': 'approximately 24 months', 'description': 'DOR is defined as the length of time between first response and the date of objectively documented progression of disease or death'}, {'measure': 'Progression-free survival (PFS)', 'timeFrame': 'approximately 24 months', 'description': 'PFS is defined as the time from date of first dose to objectively documented progression of disease or death'}, {'measure': 'Disease control rate (DCR) at 24 months', 'timeFrame': 'approximately 24 months', 'description': 'DCR is defined as the percentage of patients who have achieved a CR, PR, or SD.'}, {'measure': 'Number of patients with treatment-emergent adverse events as assessed by CTCAE v5.0', 'timeFrame': 'Approximately 24 months', 'description': 'Evaluate safety and tolerability of futibatinib in combination with binimetinib based on treatment-emergent adverse events per CTCAE v5.0(including serious adverse events),clinical laboratory parameters, ECGs, and vital signs'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Futibatinib', 'Binimetinib', 'MEKi', 'FGFR', 'FGFRi', 'TAS-120', 'KRASmt', 'NSCLC'], 'conditions': ['Advanced or Metastatic Solid Tumors Irrespective of Gene Alterations', 'Non-Small Cell Lung Cancer', 'KRAS Gene Mutation']}, 'descriptionModule': {'briefSummary': 'Phase 1b/2 study to evaluate the FGFRi futibatinib in combination with the MEKi binimetinib in patients with advanced KRASmt tumors.', 'detailedDescription': 'This is an open-label, nonrandomized, uncontrolled Phase 1b/2 study to determine the recommended phase 2 dose (RP2D) of futibatinib in combination with binimetinib and to explore the preliminary antitumor activity of futibatinib in combination with binimetinib in patients with advanced KRASmt tumors.\n\nThe study will consist of two parts:\n\n* Part 1: Dose-Escalation part to determine the RP2D and dosing schedule of futibatinib in combination with binimetinib in patients with advanced cancer disease\n* Part 2: Dose-Expansion part to evaluate the preliminary antitumor activity of futibatinib in combination with binimetinib at the RP2D in patients with advanced KRASmt NSCLC\n\nPatients will receive study treatment until progressive disease or any other discontinuation or withdrawal criterion is met.\n\nNo patients were enrolled in Phase 2 as the Sponsor decided to not proceed with the dose expansion Phase 2 part of the TAS-120-204 study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically confirmed advanced cancer of any tumor type (Part 1) or NSCLC with a confirmed KRAS mutation as determined by local results (Part 2)\n* Appropriate candidate for experimental therapy\n* For patients in Part 2 only: Patient has radiographically measurable disease per RECIST 1.1 criteria.\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.\n* Adequate cardiac function (Left ventricular ejection fraction (LVEF) ≥50% )\n* Adequate organ function\n* Must have tumor tissue specimen available (optional for patients in Part 1)\n\nExclusion Criteria:\n\n* History or current evidence of calcium and phosphate hemostasis disorder or systemic mineral imbalance with ectopic calcification of soft tissues\n* Current evidence or history of clinically significant corneal or retinal disorder as confirmed by ophthalmologic examination.\n* Known untreated central nervous system (CNS) metastases or history of uncontrolled seizures.\n* Significant gastrointestinal disorder(s) that could interfere with absorption of futibatinib/binimetinib\n* Patients who have neuromuscular disorders that are associated with elevated creatinine kinase (CK)'}, 'identificationModule': {'nctId': 'NCT04965818', 'briefTitle': 'Phase 1b/2 Study of Futibatinib in Combination With Binimetinib in Patients With Advanced KRAS Mutant Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Taiho Oncology, Inc.'}, 'officialTitle': 'A Phase 1b/2 Open-label, Nonrandomized Study of FGFR Inhibitor Futibatinib in Combination With MEK-inhibitor Binimetinib in Patients With Advanced KRAS Mutant Cancer', 'orgStudyIdInfo': {'id': 'TAS-120-204'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Futibitanib in combination with binimetinib', 'description': 'Dose escalation: Futibitanib in combination with binimetinib in patients with advanced cancer disease.\n\nDose expansion: Futibatinib in combination with binimetinib at the RP2D in patients with advanced KRASmt NSCLC', 'interventionNames': ['Drug: Futibatinib and Binimetinib']}], 'interventions': [{'name': 'Futibatinib and Binimetinib', 'type': 'DRUG', 'description': 'Patients will receive futibatinib once daily in combination with binimetinib twice daily by oral administration on a 21-day cycle', 'armGroupLabels': ['Futibitanib in combination with binimetinib']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90404', 'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'facility': 'University of California Los Angeles UCLA Cancer', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}, {'zip': '46250', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Community Cancer Center North', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'The University of Texas MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taiho Oncology, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}