Ignite Creation Date:
2025-12-24 @ 6:28 PM
Ignite Modification Date:
2025-12-29 @ 9:54 AM
Study NCT ID:
NCT05245968
Status:
RECRUITING
Last Update Posted:
2025-02-28
First Post:
2022-01-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Pimitespib in Combination With Imatinib in Patients With GIST (CHAPTER-GIST-101)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D046152', 'term': 'Gastrointestinal Stromal Tumors'}], 'ancestors': [{'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': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000596495', 'term': 'TAS-116'}, {'id': 'D000068877', 'term': 'Imatinib Mesylate'}, {'id': 'D000077210', 'term': 'Sunitinib'}], 'ancestors': [{'id': 'D001549', 'term': 'Benzamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001565', 'term': 'Benzoates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D011758', 'term': 'Pyrroles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 78}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-26', 'studyFirstSubmitDate': '2022-01-17', 'studyFirstSubmitQcDate': '2022-02-17', 'lastUpdatePostDateStruct': {'date': '2025-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dose-limiting toxicity (DLT) of pimitespib in combination with imatinib', 'timeFrame': 'At the end of Cycle 1 (each cycle is 28 days)'}, {'measure': 'Maximum tolerable dose (MTD) of pimitespib in combination with imatinib', 'timeFrame': 'At the end of Cycle 1 (each cycle is 28 days)'}, {'measure': 'Progression-free survival (PFS)', 'timeFrame': 'approximately 2 years'}], 'secondaryOutcomes': [{'measure': 'Overall survival (OS)', 'timeFrame': 'approximately 2 years'}, {'measure': 'Overall response rate (ORR)', 'timeFrame': 'approximately 2 years'}, {'measure': 'Disease control rate (DCR)', 'timeFrame': 'approximately 2 years'}, {'measure': 'Duration of response (DoR)', 'timeFrame': 'approximately 2 years'}, {'measure': 'Adverse event (AE)', 'timeFrame': 'approximately 2 years'}, {'measure': 'Adverse drug reaction (ADR)', 'timeFrame': 'approximately 2 years'}, {'measure': 'Maximum plasma concentration (Cmax)', 'timeFrame': 'Multiple time points on Day 1 and Day5 or Day12 of Cycle 1 (each cycle is 28 days)'}, {'measure': 'Time to reach maximum plasma concentration (Tmax)', 'timeFrame': 'Multiple time points on Day 1 and Day5 or Day12 of Cycle 1 (each cycle is 28 days)'}, {'measure': 'Under the plasma concentration-time curve up to the last observable concentration (AUC0-last)', 'timeFrame': 'Multiple time points on Day 1 and Day5 or Day12 of Cycle 1 (each cycle is 28 days)'}, {'measure': 'Area under the plasma concentration-time curve from time 0 to infinity (AUC0-inf)', 'timeFrame': 'Multiple time points on Day 1 and Day5 or Day12 of Cycle 1 (each cycle is 28 days)'}, {'measure': 'λz', 'timeFrame': 'Multiple time points on Day 1 and Day5 or Day12 of Cycle 1 (each cycle is 28 days)'}, {'measure': 'Half-life (T1/2)', 'timeFrame': 'Multiple time points on Day 1 and Day5 or Day12 of Cycle 1 (each cycle is 28 days)'}, {'measure': 'Oral clearance (CL/F)', 'timeFrame': 'Multiple time points on Day 1 and Day5 or Day12 of Cycle 1 (each cycle is 28 days)'}, {'measure': 'Apparent volume of distribution (Vz/F)', 'timeFrame': 'Multiple time points on Day 1 and Day5 or Day12 of Cycle 1 (each cycle is 28 days)'}, {'measure': 'Mean residence time (MRT)', 'timeFrame': 'Multiple time points on Day 1 and Day5 or Day12 of Cycle 1 (each cycle is 28 days)'}, {'measure': 'Accumulation ratio', 'timeFrame': 'Multiple time points on Day 1 and Day5 or Day12 of Cycle 1 (each cycle is 28 days)'}, {'measure': 'Metabolite ratio', 'timeFrame': 'Multiple time points on Day 1 and Day5 or Day12 of Cycle 1 (each cycle is 28 days)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gastrointestinal Stromal Tumors']}, 'descriptionModule': {'briefSummary': 'This study consists of Dose escalation part and Expansion part. In Dose Escalation Part, the maximum tolerated dose of combination of pimitespib and imatinib in patients with gastrointestinal stromal tumors (GIST) who are judged to be refractory to imatinib, estimate the recommended dose, evaluate safety and pharmacokinetics, and observe the antitumor effect. Expansion part consists of 3 arms. In Arm A, the efficacy and safety will be evaluated, which of the combination of pimitespib and imatinib in patients with GIST who have failed imatinib at doses below the MTD determined in Dose Escalation Part. In Arm B, the efficacy and safety of pimitespib monotherapy will be evaluated and the therapeutic effect of imatinib administration after pimitespib will be evaluated in an exploratory manner. In Arm C, the efficacy and safety of sunitinib monotherapy will be evaluated as reference data.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Provided written informed consent\n* Histologically confirmed GIST\n* Has radiographic progression based on RECIST 1.1 during or within 6 months of the last imatinib administration at enrollment. If surgery/radiotherapy has been performed, radiographic progression based on RECIST 1.1 with imatinib must have been observed after the last surgery /radiotherapy\n* Has at least one measurable lesion based on the RECIST version 1.1, except lymph nodes (not dependent on size), which should be chosen as nontarget lesions;\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1\n\nExclusion Criteria:\n\n* Corrected visual acuity \\< 0.5 (using the International Visual Acuity Measurement Standard) for both eyes\n* Received treatment with any other line of therapy besides imatinib for advanced GIST\n* History of total gastrectomy and/or whole resection of the small intestine\n* A serious illness or medical condition\n* Previous or concurrent cancer that is distinct in primary disease or histology from cancer that is being evaluated in this study. However, any previous cancer curatively treated \\> 5 years before the enrollment can be eligible\n* Pregnancy or lactation (including lactation interruption)'}, 'identificationModule': {'nctId': 'NCT05245968', 'briefTitle': 'A Study of Pimitespib in Combination With Imatinib in Patients With GIST (CHAPTER-GIST-101)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Taiho Pharmaceutical Co., Ltd.'}, 'officialTitle': 'A Phase 1 Study of TAS-116 (Pimitespib) in Combination With Imatinib in Patients With Advanced Gastrointestinal Stromal Tumor', 'orgStudyIdInfo': {'id': '10058060'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dose Escalation Part', 'description': 'Pimitespib in combination with imatinib', 'interventionNames': ['Drug: Pimitespib', 'Drug: Imatinib']}, {'type': 'EXPERIMENTAL', 'label': 'Expansion Part-A', 'description': 'Pimitespib in combination with imatinib', 'interventionNames': ['Drug: Pimitespib', 'Drug: Imatinib']}, {'type': 'EXPERIMENTAL', 'label': 'Expansion Part-B', 'description': 'Pimitespib followed by imatinib', 'interventionNames': ['Drug: Pimitespib', 'Drug: Imatinib']}, {'type': 'EXPERIMENTAL', 'label': 'Expansion Part-C', 'description': 'Sunitinib', 'interventionNames': ['Drug: Sunitinib']}], 'interventions': [{'name': 'Pimitespib', 'type': 'DRUG', 'otherNames': ['TAS-116'], 'description': 'Pimitespib will be administered orally in 5 consecutive days followed by 2 days off treatment (QD 5) on an empty stomach at least 1 hour before or 2 hours after a meal. The doses in the Dose Escalation Part will be 80, 120 (starting dose), and 160 mg. The doses used in Arm A will be MTD or recommended dose (RD) based on the information, including the safety and the pharmacokinetics (PK) data in the Dose Escalation Part. In Expansion Part-B, pimitespib will be administered with the starting dose of 160 mg daily.', 'armGroupLabels': ['Dose Escalation Part', 'Expansion Part-A', 'Expansion Part-B']}, {'name': 'Imatinib', 'type': 'DRUG', 'description': 'Imatinib will be administered orally, after a meal and large glass of water QD. The doses in Dose Escalation Part will be 400 mg or 300 mg (De-escalation). The doses used in Expansion Part-A will be MTD or RD based on information, including the safety and PK data in the Dose Escalation Part. In Expansion Part-B, imatinib will be administered post after pimitespib discontinuation with the starting dose of 400 mg daily.', 'armGroupLabels': ['Dose Escalation Part', 'Expansion Part-A', 'Expansion Part-B']}, {'name': 'Sunitinib', 'type': 'DRUG', 'description': 'Sunitinib will be administered orally QD with a starting dose of 50 mg, on a schedule of 4 weeks on treatment followed by 2 weeks off, and will be taken with or without a meal in Expansion Part-C.', 'armGroupLabels': ['Expansion Part-C']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Adelaide', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Amitesh Roy', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Flinders Medical Center', 'geoPoint': {'lat': -34.92866, 'lon': 138.59863}}, {'city': 'Melbourne', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'John R Zalcberg', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Alfred Health', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Lin Shen', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Beijing Cancer Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Shanghai', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ye Zhou', 'role': 'CONTACT'}], 'facility': 'Fudan University, Shanghai Cancer Center', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Chiba', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Yoichi Naito', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'National Cancer Center Hospital East', 'geoPoint': {'lat': 35.6, 'lon': 140.11667}}, {'city': 'Hokkaido', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Yoshito Komatsu', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hokkaido University Hospital'}, {'city': 'Kumamoto', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Masaaki Iwatsuki', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Kumamoto University Hospital', 'geoPoint': {'lat': 32.80589, 'lon': 130.69181}}, {'city': 'Osaka', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Yukinori Kurokawa', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Osaka University Hospital', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'city': 'Tokyo', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Hidekazu Hirano', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'National Cancer Center Hospital', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'city': 'Tokyo', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Masato Ozaka', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The Cancer Institute Hospital of JFCR', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'city': 'Singapore', 'status': 'RECRUITING', 'country': 'Singapore', 'contacts': [{'name': 'Yong Wei Peng', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'National University Cancer Institute', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}, {'city': 'Kaohsiung City', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Li-Tzong Chen', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Kaohsiung Medical University Hospital', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}, {'city': 'Linkou District', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Jen-Shi Chen', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Linkou Chang Gung Memorial Hospital', 'geoPoint': {'lat': 25.07777, 'lon': 121.39348}}, {'city': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Chueh-Chuan Yen', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Taipei Veterans General Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'centralContacts': [{'name': 'Drug Information Center', 'role': 'CONTACT', 'email': 'n-arimura@taiho.co.jp', 'phone': '+81-3-3294-4527'}], 'overallOfficials': [{'name': 'Taiho Pharmaceutical Co., Ltd.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Taiho Pharmaceutical Co., Ltd.'}]}, 'ipdSharingStatementModule': {'url': 'https://vivli.org/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'https://www.taiho.co.jp/en/science/policy/clinical\\_trial\\_information\\_disclosure\\_policy/index.html', 'ipdSharing': 'YES', 'description': "Taiho provides a platform for accepting researchers' requests for sharing anonymized, patient-level, analyzable datasets from articles published in peer-reviewed journals about the primary results from Taiho-sponsored interventional clinical trials in patients in which the medicine and the indication has received marketing approval from regulatory authorities in the United States, the European Union, and/or Japan on or after January 15, 2018.", 'accessCriteria': 'Access to the clinical trial data is contingent upon approval of a proposed study protocol by an independent review panel and the execution of a data-sharing agreement with the researcher.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taiho Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}