Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2026-02-22 @ 4:47 AM
Study NCT ID:
NCT02925104
Status:
COMPLETED
Last Update Posted:
2020-12-19
First Post:
2016-10-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Dose Escalation Study to Assess PK, Safety and Tolerability of INC280 When Taken With Food in cMET Dysregulated Advanced Solid Tumors.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000613976', 'term': 'capmatinib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-12-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2018-05-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-16', 'studyFirstSubmitDate': '2016-10-04', 'studyFirstSubmitQcDate': '2016-10-04', 'lastUpdatePostDateStruct': {'date': '2020-12-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-10-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-05-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Dose limiting toxiticites (DLTs)', 'timeFrame': 'During the first 28 days on INC280 treatment; cycle = 21 days'}, {'measure': 'Frequency of DLTs', 'timeFrame': 'During the first 28 days on INC280 treatment'}, {'measure': 'Category of DLTs', 'timeFrame': 'During the first 28 days on INC280 treatment'}, {'measure': 'AUClast for INC280', 'timeFrame': 'Treatment Cycle 1 Day 1 (C1D1), C1D7, C1D15, C2D1, C3D1'}, {'measure': 'AUCtau for INC280', 'timeFrame': 'C1D1, C1D7, C1D15, C2D1, C3D1'}, {'measure': 'Cmax for INC280', 'timeFrame': 'C1D1, C1D7, C1D15, C2D1, C3D1'}, {'measure': 'Tmax', 'timeFrame': 'C1D1, C1D7, C1D15, C2D1, C3D1'}], 'secondaryOutcomes': [{'measure': 'Adverse events based on CTCAE grading and other safety variables (e.g. EGC readings, physical examination, vital signs and laboratory results).', 'timeFrame': 'Screening, until 30 days post-treatment'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cMET, INC280, food,'], 'conditions': ['cMET Dysegulation Advanced Solid Tumors']}, 'referencesModule': {'references': [{'pmid': '34053700', 'type': 'DERIVED', 'citation': 'Moreno V, Greil R, Yachnin J, Majem M, Wermke M, Arkenau HT, Basque JR, Nidamarthy PK, Kapoor S, Cui X, Giovannini M. Pharmacokinetics and safety of capmatinib with food in patients with MET-dysregulated advanced solid tumors. Clin Ther. 2021 Jun;43(6):1092-1111. doi: 10.1016/j.clinthera.2021.04.006. Epub 2021 May 27.'}], 'seeAlsoLinks': [{'url': 'https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=17391', 'label': 'Results for CINC280A2108 can be found on the Novartis Clinical Trial Results Website'}]}, 'descriptionModule': {'briefSummary': 'Dose escalation study to assess PK, safety and tolerability of INC280 when taken with food in patients with cMET dysregulated advanced solid tumors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* cMET dysregulated advanced solid tumor\n* At least one measurable lesion as defined by RECIST 1.1\n* Recovered from all toxicities related to prior anti-cancer therapies to grade ≤ 1\n* Adequate organ function\n* ECOG performance status (PS) ≤ 1\n\nExclusion Criteria:\n\n* Prior treatment with crizotinib or any other cMET or HGF inhibitor\n* Known hypersensitivity to any of the excipients of INC280\n* Symptomatic central nervous system (CNS) metastases who are neurologically unstable\n* Presence or history of a malignant disease other than the study related cancer\n* Clinically significant, uncontrolled heart diseases\n* Thoracic radiotherapy to lung fields ≤ 4 weeks prior to starting INC280 or patients who have not recovered from radiotherapy-related toxicities\n* Major surgery within 4 weeks prior to starting INC280\n* Impairment of GI function\n* Patients receiving unstable or increasing doses of corticosteroids\n* Patients receiving treatment with any enzyme-inducing anticonvulsant\n* Pregnant or nursing (lactating) women Other protocol-related inclusion/exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT02925104', 'briefTitle': 'A Dose Escalation Study to Assess PK, Safety and Tolerability of INC280 When Taken With Food in cMET Dysregulated Advanced Solid Tumors.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Multicenter, Open Label, Phase 1 Dose Escalation Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of INC280 Tablet Formulation With Food in Patients With cMET Dysregulated Advanced Solid Tumors.', 'orgStudyIdInfo': {'id': 'CINC280A2108'}, 'secondaryIdInfos': [{'id': '2016-001829-14', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'INC280', 'interventionNames': ['Drug: INC280']}], 'interventions': [{'name': 'INC280', 'type': 'DRUG', 'armGroupLabels': ['INC280']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University Simon Cancer Center SC', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '5020', 'city': 'Salzburg', 'country': 'Austria', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 47.79941, 'lon': 13.04399}}, {'zip': '2730', 'city': 'Herlev', 'country': 'Denmark', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 55.72366, 'lon': 12.43998}}, {'zip': '01307', 'city': 'Dresden', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'zip': '55131', 'city': 'Mainz', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 49.98185, 'lon': 8.28008}}, {'zip': '6500 HB', 'city': 'Nijmegen', 'country': 'Netherlands', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}, {'zip': '29010', 'city': 'Málaga', 'state': 'Andalusia', 'country': 'Spain', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 36.72016, 'lon': -4.42034}}, {'zip': '15706', 'city': 'Santiago de Compostela', 'state': 'Galicia', 'country': 'Spain', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 42.88052, 'lon': -8.54569}}, {'zip': '08041', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '28040', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '50009', 'city': 'Zaragoza', 'country': 'Spain', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 41.65606, 'lon': -0.87734}}, {'zip': '413 45', 'city': 'Gothenburg', 'country': 'Sweden', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}, {'zip': 'SE-221 85', 'city': 'Lund', 'country': 'Sweden', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 55.70584, 'lon': 13.19321}}, {'zip': '171 76', 'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}, {'zip': 'SE-751 85', 'city': 'Uppsala', 'country': 'Sweden', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 59.85882, 'lon': 17.63889}}, {'zip': 'W1G 6AD', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'M20 4BX', 'city': 'Manchester', 'country': 'United Kingdom', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}