Ignite Creation Date:
2025-12-24 @ 10:16 PM
Ignite Modification Date:
2026-03-15 @ 5:14 AM
Study NCT ID:
NCT01964235
Status:
WITHDRAWN
Last Update Posted:
2016-09-01
First Post:
2013-10-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Efficacy and Safety INC280 in Patients With Advanced Hepatocellular Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Austria']}, 'interventionBrowseModule': {'meshes': [{'id': 'C000613976', 'term': 'capmatinib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Study was cancelled by Sponsor.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2016-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2019-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-08-30', 'studyFirstSubmitDate': '2013-10-14', 'studyFirstSubmitQcDate': '2013-10-14', 'lastUpdatePostDateStruct': {'date': '2016-09-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-10-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to progression using Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1', 'timeFrame': 'baseline, 6 weeks up to 6 months', 'description': 'Time to progression is the time from the date of baseline evaluation to the date of the first documented radiological confirmation of disease progression.'}], 'secondaryOutcomes': [{'measure': 'Best Overall Response', 'timeFrame': 'date of treatment, every 6 weeks up to 6 months', 'description': 'Best overall response is defined as the best response recorded from the date of randomization until the date of last tumor assessment per RECIST version 1.1.'}, {'measure': 'Overall Response Rate', 'timeFrame': 'baseline, every 6 weeks up to 6 months', 'description': 'Overall Response Rate is defined as the proportion of patients with a best overall response of complete response or partial response at any time on study per RECIST version 1.1.'}, {'measure': 'Disease Control Rate', 'timeFrame': 'baseline, every 6 weeks up to 6 months', 'description': 'Disease control rate is defined as the proportion of patients with a best overall response of complete response, partial response or stable disease at any time on study per RECIST version 1.1.'}, {'measure': 'Progression Free Survival', 'timeFrame': 'randomization, every 6 weeks up to 6 months', 'description': 'Progression free survival is defined as the time from date of randomization to the date of the first radiologically documented progression or death due to any cause. If a patient has not experienced radiologically documented progression or death, progression free survival is censored at the date of last adequate tumor assessment.'}, {'measure': 'Overall Survival', 'timeFrame': 'randomization until death, average 10 months', 'description': 'Overall survival is defined as the time from date of randomization to the date of death due to any cause. If a patient is not known to have died, survival will be censored at the date of last contact.'}, {'measure': 'Safety: adverse events, serious adverse events', 'timeFrame': 'From baseline until 30 days post study treatment', 'description': 'Frequency, duration and severity of adverse events.'}, {'measure': 'Safety: hematology and chemistry values, vital signs, electrocardiograms', 'timeFrame': 'From baseline until end of treatment, average 6 months from baseline', 'description': 'Change from baseline values.'}, {'measure': 'Tolerability of study drug', 'timeFrame': 'From date of randomization until end of treatment, average 6 months from baseline', 'description': 'Tolerability will be assessed by summarizing the number of dose interruptions, dose reductions and dose intensity.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['INC280, advanced hepatocellular carcinoma, c-MET pathway dysregulation.'], 'conditions': ['Advanced Hepatocellular Carcinoma']}, 'descriptionModule': {'briefSummary': "This study is establish whether INC280 is safe and has beneficial effects in patients with advanced hepatocellular carcinoma known to have dysregulation of c-MET pathway and whose disease progressed while on, or after, treatment with sorafenib or who are intolerant to sorafenib.\n\nPatients will be randomized in a 2:1 ratio to receive INC280 at 600mg BID plus best supportive care (BSC) or placebo plus BSC, until disease progression or intolerable to study treatment. Patients treated with placebo plus BSC will have the opportunity to receive INC280 treatment upon documented further disease progression (RECIST 1.1) per investigator's discretion after unblinding.\n\nPatient will be stratified to geographical region (Asia vs Rest of World ) and tumor burden (present macroscopic vascular invasion and/or extra-hepatic spread vs not present).", 'detailedDescription': 'Study was cancelled by Sponsor prior to enrollment of patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Confirmed c-MET pathway dysregulation.- Hepatocellular carcinoma stage B or C according to the Barcelona Clinic Liver cancer staging classification. - Current cirrhotic status of Child-Pugh class A with no encephalopathy. - Documented disease progression during or after discontinuation of sorafenib treatment or intolerance to sorafenib treatment. - Measurable disease as determined by RECIST v1.1. - ECOG performance status ≤ 1\n\nExclusion Criteria:\n\n* Previous local antineoplastic therapy or investigational drug completed less than 5 half-lives of the agent prior to randomization and have not recovered from clinically significant toxicity from such treatment to grade ≤1 by the NCI-CTCAE. - Received any targeted therapy other than sorafenib.\n* Active bleeding within 28 days prior to screening visit including variceal bleeding (esophageal varices should be treated according to standard practice and procedure completed 28 days prior to screening visit). - Clinically significant venous or arterial thrombotic disease within past 6 months.'}, 'identificationModule': {'nctId': 'NCT01964235', 'briefTitle': 'Study of Efficacy and Safety INC280 in Patients With Advanced Hepatocellular Carcinoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Randomized Phase II, Double-blind, Placebo-controlled, Multi-center Study to Evaluate the Efficacy and Safety of INC280 in Adult Patients With Advanced Hepatocellular Carcinoma After Progression or Intolerance to Sorafenib Treatment', 'orgStudyIdInfo': {'id': 'CINC280X2203'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'INC280 plus best supportive care', 'description': 'Approximately 46 patients will be treated with INC280 600 mg twice a day plus best supportive care.', 'interventionNames': ['Drug: INC280']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo plus best supportive care', 'description': 'Approximately 23 patients will be treated with matching placebo twice a day plus best supportive care.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'INC280', 'type': 'DRUG', 'description': 'INC280 will be administered orally and continuously on a twice a day dosing schedule.', 'armGroupLabels': ['INC280 plus best supportive care']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo will be administered orally and continuously on a twice a day dosing schedule.', 'armGroupLabels': ['Placebo plus best supportive care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital Mass General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '64132', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': 'Research Medical Center Onc Dept', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '2217', 'city': 'Kogarah', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': -33.9681, 'lon': 151.13564}}, {'zip': '3084', 'city': 'Heidelberg', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': -37.75, 'lon': 145.06667}}, {'zip': '92110', 'city': 'Clichy', 'country': 'France', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 48.90018, 'lon': 2.30952}}, {'zip': '59037', 'city': 'Lille', 'country': 'France', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '34298', 'city': 'Montpellier', 'country': 'France', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '06202', 'city': 'Nice', 'country': 'France', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'zip': '45147', 'city': 'Essen', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'zip': '97080', 'city': 'Würzburg', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 49.79391, 'lon': 9.95121}}, {'city': 'Hong Kong', 'country': 'Hong Kong', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}, {'city': 'Hong Kong SAR', 'country': 'Hong Kong', 'facility': 'Novartis Investigative Site'}, {'zip': '14004', 'city': 'Córdoba', 'state': 'Andalusia', 'country': 'Spain', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 37.89155, 'lon': -4.77275}}, {'zip': '3010', 'city': 'Bern', 'country': 'Switzerland', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}, {'zip': '1211', 'city': 'Geneva', 'country': 'Switzerland', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 46.20222, 'lon': 6.14569}}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}