Ignite Creation Date:
2025-12-24 @ 6:40 PM
Ignite Modification Date:
2026-02-22 @ 6:44 PM
Study NCT ID:
NCT02029157
Status:
COMPLETED
Last Update Posted:
2017-10-09
First Post:
2013-12-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Randomized Double-blind, Placebo-controlled Japanese Phase III Trial of ARQ 197 in Hepatocellular Carcinoma (HCC)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008113', 'term': 'Liver Neoplasms'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C551661', 'term': 'ARQ 197'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 386}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2017-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-06', 'studyFirstSubmitDate': '2013-12-27', 'studyFirstSubmitQcDate': '2014-01-06', 'lastUpdatePostDateStruct': {'date': '2017-10-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-01-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-free survival (PFS)', 'timeFrame': 'Estimated median of 8-12 weeks in PFS', 'description': 'Progression-free survival will be compared between ARQ 197 group and Placebo group, to prove the efficacy of ARQ 197 in the population.'}], 'secondaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': 'Estimated median of 24 weeks in overall survival', 'description': 'The date of the events was followed every three months after the end of the treatments of the study drug.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Liver Cancer']}, 'referencesModule': {'references': [{'pmid': '32716114', 'type': 'DERIVED', 'citation': 'Kudo M, Morimoto M, Moriguchi M, Izumi N, Takayama T, Yoshiji H, Hino K, Oikawa T, Chiba T, Motomura K, Kato J, Yasuchika K, Ido A, Sato T, Nakashima D, Ueshima K, Ikeda M, Okusaka T, Tamura K, Furuse J. A randomized, double-blind, placebo-controlled, phase 3 study of tivantinib in Japanese patients with MET-high hepatocellular carcinoma. Cancer Sci. 2020 Oct;111(10):3759-3769. doi: 10.1111/cas.14582. Epub 2020 Aug 26.'}]}, 'descriptionModule': {'briefSummary': 'The present clinical trial is aiming to evaluate efficacy of ARQ 197 in patients with hepatocellular carcinoma (HCC), who were resistant or intolerable to one systemic chemotherapy regimen including sorafenib.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Informed consent form\n* ≥20 years old\n* Inoperable HCC which is not eligible for locoregional therapy\n* Diagnosed as c-Met high in tumor sample\n* Radiographic progression is confirmed during or after systemic chemotherapy including sorafenib, or those who are intolerance to the chemotherapy.\n* Eastern Cooperative Oncology Group Performance Status (ECOG PS) is 0 or 1\n* Child-Pugh Class A\n* Having measurable target lesions which are defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1,\n* Negative pregnancy test results\n* Adequate organ function\n* Life expectancy of at least 12 weeks\n\nExclusion Criteria:\n\n* More than 2 prior systemic chemotherapy.\n* Prior therapy of c-Met inhibitor (including antibody)\n* Any systemic therapy within ≤2 weeks prior to the randomization\n* Locoregional therapy within ≤4 weeks prior to randomization.\n* Major surgery within ≤4 weeks prior to the randomization\n* Concurrent cancer within ≤5 years prior to the randomization\n* History of cardiac diseases\n* Active clinically serious infections defined as ≥ Grade 3 according to Common Toxicity Criteria for Adverse Effects (CTCAE) 4.0\n* Any psychological disorder affecting Informed Consent\n* Diagnosis positive for anti-HIV antibody and/or anti-HTLV-1 antibody\n* Blood or albumin transfusion within ≤14 days prior to the screening test\n* Concurrent interferon therapy against Hepatitis B Virus (HBV)/ Hepatitis C Virus (HCV)\n* Symptomatic brain metastases\n* History of liver transplantation\n* Inability to swallow oral medications\n* Confirmed interstitial lung disease\n* Pleural effusion and/or clinically significant ascites\n* Pregnancy or breast-feeding\n* Without consent to effective single or combined contraceptive methods'}, 'identificationModule': {'nctId': 'NCT02029157', 'acronym': 'JET-HCC', 'briefTitle': 'A Randomized Double-blind, Placebo-controlled Japanese Phase III Trial of ARQ 197 in Hepatocellular Carcinoma (HCC)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Kyowa Kirin Co., Ltd.'}, 'officialTitle': 'A Phase III Randomized Double-blind, Placebo-controlled Trial of ARQ 197 in Subjects With c-MET Diagnostic-high Inoperable Hepatocellular Carcinoma (HCC) Treated With One Prior Sorafenib Therapy', 'orgStudyIdInfo': {'id': 'ARQ 197-009'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ARQ 197', 'description': 'Daily oral dose', 'interventionNames': ['Drug: ARQ197']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Daily oral dose', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'ARQ197', 'type': 'DRUG', 'armGroupLabels': ['ARQ 197']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tokyo', 'country': 'Japan', 'facility': 'Cancer Centers in Japan', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kyowa Kirin Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}