Ignite Creation Date:
2025-12-24 @ 7:18 PM
Ignite Modification Date:
2026-02-18 @ 5:43 PM
Study NCT ID:
NCT00612703
Status:
COMPLETED
Last Update Posted:
2012-07-23
First Post:
2008-01-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase 1 Study of ARQ 197 in Adult Patients With Advanced Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C551661', 'term': 'ARQ 197'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'lastUpdateSubmitDate': '2012-07-20', 'studyFirstSubmitDate': '2008-01-30', 'studyFirstSubmitQcDate': '2008-01-30', 'lastUpdatePostDateStruct': {'date': '2012-07-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-02-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To determine the safety, tolerability and recommended Phase 2 dose of ARQ 197 when administered in combination with erlotinib to patients with advanced solid tumors', 'timeFrame': 'No time frame'}], 'secondaryOutcomes': [{'measure': 'To determine the pharmacokinetic profiles of ARQ 197 and erlotinib, when administered in combination to patients with advanced solid tumors', 'timeFrame': 'No time frame'}, {'measure': 'To assess the preliminary anti-tumor activity of ARQ 197 when administered in combination with erlotinib to adult patients with advanced solid tumors', 'timeFrame': 'No time frame'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cancer, oral, erlotinib, tarceva, solid tumor, advanced tumor, phase 1', 'Tumor'], 'conditions': ['Cancer']}, 'referencesModule': {'references': [{'pmid': '22605616', 'type': 'DERIVED', 'citation': 'Goldman JW, Laux I, Chai F, Savage RE, Ferrari D, Garmey EG, Just RG, Rosen LS. Phase 1 dose-escalation trial evaluating the combination of the selective MET (mesenchymal-epithelial transition factor) inhibitor tivantinib (ARQ 197) plus erlotinib. Cancer. 2012 Dec 1;118(23):5903-11. doi: 10.1002/cncr.27575. Epub 2012 May 17.'}]}, 'descriptionModule': {'briefSummary': 'To determine the safety, tolerability and recommended Phase 2 dose of ARQ 197 when administered in combination with erlotinib to patients with advanced solid tumors'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed written informed consent must be obtained and documented according to International Conference on Harmonization (ICH)- Good Clinical Practice (GCP), the local regulatory requirements, and permission to use private health information in accordance with the Health Insurance Portability and Accountability Act (HIPPA) prior to study-specific screening procedures\n* A histologically or cytologically confirmed solid tumor that is advanced, metastatic, and/or inoperable following prior standard chemotherapy, and/or for which, in the opinion of the investigator, there is no alternative therapy, or for which monotherapy with erlotinib is appropriate\n* ≥ 18 years of age\n* Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST)\n\nExclusion Criteria:\n\n* Anti-cancer chemotherapy, radiotherapy, immunotherapy, or investigational agents within four weeks of first dose (patients currently on erlotinib monotherapy may be enrolled into the study without a washout)\n* Major surgery within 4 weeks prior to first dose\n* Central nervous system metastasis unless it has been stable for ≥ 3 months after treatment and patient has no neural symptoms\n* Pregnant or breastfeeding\n* Significant gastrointestinal disorder that, in the opinion of the Investigator, could interfere with the absorption of ARQ 197 and/or erlotinib (e.g. significant, uncontrolled inflammatory bowel disease or extensive small bowel resection)'}, 'identificationModule': {'nctId': 'NCT00612703', 'briefTitle': 'A Phase 1 Study of ARQ 197 in Adult Patients With Advanced Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)'}, 'officialTitle': 'A Phase 1 Dose Escalation Study of ARQ 197 Administered in Combination With Erlotinib in Adult Patients With Advanced Solid Tumors', 'orgStudyIdInfo': {'id': 'ARQ 197-111'}}, 'armsInterventionsModule': {'interventions': [{'name': 'ARQ 197', 'type': 'DRUG', 'description': 'Treatment with ARQ 197 in combination with erlotinib'}]}, 'contactsLocationsModule': {'locations': [{'zip': '92024', 'city': 'Encinitas', 'state': 'California', 'country': 'United States', 'facility': 'San Diego Pacific Oncology and Hematology Associates Inc.', 'geoPoint': {'lat': 33.03699, 'lon': -117.29198}}, {'zip': '90404', 'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'facility': 'Premiere Oncology', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}], 'overallOfficials': [{'name': 'Lee Rosen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Premiere Oncology of Santa Monica'}, {'name': 'Richard G Just, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pacific Oncology and Hematology Associates'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}