Ignite Creation Date:
2025-12-24 @ 6:36 PM
Ignite Modification Date:
2025-12-27 @ 4:43 PM
Study NCT ID:
NCT01069757
Status:
COMPLETED
Last Update Posted:
2017-03-15
First Post:
2010-02-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of ARQ 197 in Combination With Erlotinib
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C551661', 'term': 'ARQ 197'}, {'id': 'D000069347', 'term': 'Erlotinib Hydrochloride'}], 'ancestors': [{'id': 'D011799', 'term': 'Quinazolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-14', 'studyFirstSubmitDate': '2010-02-15', 'studyFirstSubmitQcDate': '2010-02-16', 'lastUpdatePostDateStruct': {'date': '2017-03-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-02-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dose-Limiting Toxicity in the combination of tivantinib and erlotinib', 'timeFrame': 'DLT observation period started from the day of first single agent treatment to the day after the continuous combination treatment for 29 days.', 'description': 'Tivantinib was treated once as a single agent on Day 1. After 2 days of interruption, dayly treatments of the combination started.'}], 'secondaryOutcomes': [{'measure': 'Plasma concentration and pharmacokinetic parameters of ARQ 197 and Erlotinib', 'timeFrame': 'Plasma sample correction at pre-dose, 1, 2, 4, 6, 10, 12 and 24 hours on Day 1; at pre-dose, 1, 2, 4, 6, 10, 12 hours on the day of the first comnibation treatment', 'description': 'Plasma concentration of tivantinib was measured on both Day 1 and the first day of the combination. Plasma concentration of erlotinib was also measured on the first day of the combination.'}, {'measure': 'Antitumor activity', 'timeFrame': 'Baseline, and then every 6 week of imaging until discontinuation criteria met'}]}, 'conditionsModule': {'keywords': ['Advanced/recurrent non-small-cell lung cancer'], 'conditions': ['Non-small-cell Lung Cancer']}, 'descriptionModule': {'briefSummary': 'This is a phase I study to determine the safety, tolerability and recommended phase II dose of ARQ 197 given in combination with erlotinib as primary endpoints in patients with advanced/recurrent non-small-cell lung cancer. The pharmacokinetic profile and antitumor activity of ARQ 197 administered alone or in combination with erlotinib will also be determined as secondary endpoints.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Voluntary written informed consent for study participation must be obtained\n* A histologically or cytologically confirmed advanced/recurrent non-small-cell lung cancer\n* History of ≥1 prior chemotherapy regimen (treatment with EGFR tyrosine kinase inhibitors will be counted as one regimen)\n* ECOG PS of 0 or 1\n* Life expectancy of ≥3 months\n\nExclusion Criteria:\n\n* Anti-cancer chemotherapy, anti-cancer therapy with EGFR-TKI, hormone therapy, radiotherapy, immunotherapy, other investigational agents or anti-cancer antibody therapy within 28 days prior to ARQ 197 dose\n* Surgery for cancer within 28 days prior to ARQ 197 dose\n* Active double cancer\n* Known symptomatic brain metastases\n* An intercurrent illness that is uncontrolled (e.g., infection, symptomatic congestive heart failure, unstable angina pectoris, symptomatic arrhythmia, interstitial pneumonia)\n* Pregnant or lactating\n* Subjects who wish to have a child and who would not agree to use contraceptive measures'}, 'identificationModule': {'nctId': 'NCT01069757', 'briefTitle': 'A Study of ARQ 197 in Combination With Erlotinib', 'organization': {'class': 'INDUSTRY', 'fullName': 'Kyowa Kirin Co., Ltd.'}, 'officialTitle': 'A Phase I Study of ARQ 197 in Combination With Erlotinib in Patients With Advanced/Recurrent Non-Small-Cell Lung Cancer', 'orgStudyIdInfo': {'id': 'ARQ 197-003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ARQ 197 and Erlotinib', 'description': 'ARQ 197 and erlotinib hydrochloride', 'interventionNames': ['Drug: ARQ 197 and Erlotinib']}], 'interventions': [{'name': 'ARQ 197 and Erlotinib', 'type': 'DRUG', 'description': 'Orally twice daily administration of ARQ 197 and orally once daily administration of erlotinib hydrochloride', 'armGroupLabels': ['ARQ 197 and Erlotinib']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Osaka', 'country': 'Japan', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'city': 'Shizuoka', 'country': 'Japan', 'geoPoint': {'lat': 34.98333, 'lon': 138.38333}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kyowa Kirin Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}