Ignite Creation Date:
2025-12-24 @ 5:58 PM
Ignite Modification Date:
2025-12-28 @ 4:16 PM
Study NCT ID:
NCT01507168
Status:
COMPLETED
Last Update Posted:
2020-04-03
First Post:
2012-01-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of GC33 (RO5137382) in Patients With Advanced or Metastatic Hepatocellular Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000619938', 'term': 'codrituzumab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 185}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-02-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2015-08-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-01', 'studyFirstSubmitDate': '2012-01-06', 'studyFirstSubmitQcDate': '2012-01-06', 'lastUpdatePostDateStruct': {'date': '2020-04-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-01-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-08-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-free survival (tumor assessments according to RECIST criteria)', 'timeFrame': 'approximately 24 months'}], 'secondaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': 'approximately 32 months'}, {'measure': 'Time to progression (TTP): Time from randomization to first documented disease progression', 'timeFrame': 'approximately 24 months'}, {'measure': 'Disease control rate (DCR): Complete response, partial response or stable disease lasting at least 6 weeks', 'timeFrame': 'approximately 24 months'}, {'measure': 'Safety: Incidence of adverse events', 'timeFrame': 'approximately 24 months'}, {'measure': 'Pharmacokinetics: Serum concentrations (Cmax,Cmin)', 'timeFrame': 'Multiple sampling pre- and post-dose Days 1 and 8 Cycle 1, Day 1 Cycle 6, pre-dose Day 1 Cycles 2-11'}, {'measure': 'GPC-3 expression in tumor tissue (biopsy) by immunohistochemistry (IHC) assay', 'timeFrame': 'at screening'}]}, 'conditionsModule': {'conditions': ['Carcinoma, Hepatocellular']}, 'referencesModule': {'references': [{'pmid': '30922327', 'type': 'DERIVED', 'citation': 'Pradier MF, Reis B, Jukofsky L, Milletti F, Ohtomo T, Perez-Cruz F, Puig O. Case-control Indian buffet process identifies biomarkers of response to Codrituzumab. BMC Cancer. 2019 Mar 28;19(1):278. doi: 10.1186/s12885-019-5472-0.'}, {'pmid': '27085251', 'type': 'DERIVED', 'citation': 'Abou-Alfa GK, Puig O, Daniele B, Kudo M, Merle P, Park JW, Ross P, Peron JM, Ebert O, Chan S, Poon TP, Colombo M, Okusaka T, Ryoo BY, Minguez B, Tanaka T, Ohtomo T, Ukrainskyj S, Boisserie F, Rutman O, Chen YC, Xu C, Shochat E, Jukofsky L, Reis B, Chen G, Di Laurenzio L, Lee R, Yen CJ. Randomized phase II placebo controlled study of codrituzumab in previously treated patients with advanced hepatocellular carcinoma. J Hepatol. 2016 Aug;65(2):289-95. doi: 10.1016/j.jhep.2016.04.004. Epub 2016 Apr 13.'}]}, 'descriptionModule': {'briefSummary': 'This randomized, placebo-controlled, multicenter study will evaluate the efficacy and safety of GC33 (RO5137382) in previously treated patients with unresectable advanced or metastatic hepatocellular carcinoma. Participants will be stratified according to the level of GPC-3 expression in tumors and randomized to receive either GC33 (1600 mg intravenously) or placebo on Days 1 and 8 of Cycle 1 and every 2 weeks thereafter. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients, \\>/= 18 years of age\n* Histologically confirmed hepatocellular carcinoma (without fibro-lamellar subtype)\n* Prior treatment with at least 1 systemic agent, with documented progressive disease after systemic agent(s), or documented adverse event(s) associated with prior systemic agent(s) that resulted in discontinuance of that (those) agent(s)\n* Not a candidate for curative treatments (e.g. resection, transplantation)\n* Child-Pugh A (score of 5-6)\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1\n* Adequate hematologic, hepatic and renal function\n* Ability to provide, for central review, a tumor tissue sample to determine the level of GPC-3 expression by IHC\n* Measurable disease by RECIST criteria\n\nExclusion Criteria:\n\n* Child Pugh B or C\n* Known hepatocellular carcinoma with fibro-lamellar histology\n* Known brain or leptomeningeal metastases\n* Active infectious diseases requiring treatment except for hepatitis B and C\n* History of organ allograft including liver transplant\n* Anticipated or ongoing administration of anticancer therapies other than those administered in this study\n* Anticancer treatment within 2 weeks prior to entering the study\n* Patients who have not fully recovered from toxicities associated with previous HCC loco-regional or systemic therapies\n* Patients receiving interferon therapy\n* Pregnant or lactating women\n* Known HIV positivity or AIDS-related illness\n* History of significant hypersensitivity to similar agents (monoclonal antibody, protein-included drugs, Chinese hamster ovary products)'}, 'identificationModule': {'nctId': 'NCT01507168', 'briefTitle': 'A Study of GC33 (RO5137382) in Patients With Advanced or Metastatic Hepatocellular Carcinoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'A Randomised, Placebo-controlled, Double-blind, Multicenter Phase II Trial of Intravenous GC33 at 1600 mg Q2W in Previously Treated Patients With Unresectable Advanced or Metastatic Hepatocellular Carcinoma (HCC)', 'orgStudyIdInfo': {'id': 'NP27884'}, 'secondaryIdInfos': [{'id': '2011-003574-84', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'GC33 (RO5137382)', 'interventionNames': ['Drug: GC33']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'description': 'iv Days 1 and 8, and every 2 weeks thereafter', 'armGroupLabels': ['Placebo']}, {'name': 'GC33', 'type': 'DRUG', 'otherNames': ['RO5137382'], 'description': '1600 mg iv Day 1 and 8, and every 2 weeks thereafter', 'armGroupLabels': ['GC33 (RO5137382)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'UCLA Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '20889-0001', 'city': 'Bethesda', 'state': 'Maryland', 'country': 'United States', 'facility': 'National Cancer Institute; Ctr for Cancer Research', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}, {'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Barbara Ann Karmanos Cancer Institute', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington Univ School of Med; Barnes-Jewish Hospital; Siteman Cancer Center', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '37232-7610', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '98104', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Swedish Cancer Inst.', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '1070', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Hospital Erasme', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '9000', 'city': 'Ghent', 'country': 'Belgium', 'facility': 'UZ Gent', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'zip': '49033', 'city': 'Angers', 'country': 'France', 'facility': 'Hotel Dieu; 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