Ignite Creation Date:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2025-12-26 @ 2:32 AM
Study NCT ID:
NCT01225302
Status:
COMPLETED
Last Update Posted:
2017-11-21
First Post:
2010-09-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of Linifanib (ABT-869) in Combination With Carboplatin/Paclitaxel in Japanese Subjects With Non-Small Cell Lung Cancer (NSCLC)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Japan']}, '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': 'C513486', 'term': 'linifanib'}, {'id': 'D016190', 'term': 'Carboplatin'}, {'id': 'D017239', 'term': 'Paclitaxel'}], 'ancestors': [{'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'completionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-11-17', 'studyFirstSubmitDate': '2010-09-28', 'studyFirstSubmitQcDate': '2010-10-19', 'lastUpdatePostDateStruct': {'date': '2017-11-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-10-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety (Number of patients with adverse events and/or dose-limiting toxicities)', 'timeFrame': 'At each treatment visit (weekly for 6 weeks, then every 3 weeks)', 'description': 'Evaluation of vital signs, physical exams, clinical lab testing and adverse event monitoring.'}], 'secondaryOutcomes': [{'measure': 'Preliminary tumor response', 'timeFrame': 'Week 6', 'description': 'Computed Tomography (CT) scan'}, {'measure': 'Preliminary tumor response', 'timeFrame': 'Week 12', 'description': 'Computed Tomography (CT) scan'}, {'measure': 'Preliminary tumor response', 'timeFrame': 'Week 18', 'description': 'Computed Tomography (CT) scan'}, {'measure': 'Preliminary tumor response', 'timeFrame': 'Week 24', 'description': 'Computed Tomography (CT) scan'}, {'measure': 'Preliminary tumor response', 'timeFrame': 'Week 30', 'description': 'Computed Tomography (CT) scan'}, {'measure': 'Preliminary tumor response', 'timeFrame': 'Week 36', 'description': 'Computed Tomography (CT) scan'}, {'measure': 'Preliminary tumor response', 'timeFrame': 'Week 42', 'description': 'Computed Tomography (CT) scan'}, {'measure': 'Preliminary tumor response', 'timeFrame': 'Week 48', 'description': 'Computed Tomography (CT) scan'}, {'measure': 'Preliminary tumor response', 'timeFrame': 'Week 54', 'description': 'Computed Tomography (CT) scan'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Non-Small Cell Lung Cancer']}, 'referencesModule': {'references': [{'pmid': '24807459', 'type': 'RESULT', 'citation': 'Horinouchi H, Yamamoto N, Nokihara H, Horai T, Nishio M, Ohyanagi F, Horiike A, Nakagawa K, Terashima M, Okabe T, Kaneda H, McKee MD, Carlson DM, Xiong H, Tamura T. A phase 1 study of linifanib in combination with carboplatin/paclitaxel as first-line treatment of Japanese patients with advanced or metastatic non-small cell lung cancer (NSCLC). Cancer Chemother Pharmacol. 2014 Jul;74(1):37-43. doi: 10.1007/s00280-014-2478-9. Epub 2014 May 8.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to assess the safety and pharmacokinetics of linifanib, and identify tolerable dose of linifanib (ABT-869) in combination with carboplatin and paclitaxel in Japanese subjects with advanced or metastatic non-small cell lung cancer (NSCLC). Secondary objective is to obtain a preliminary efficacy of anti-tumor activity in the subjects as first-line treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* The subject must be 20 and older years of age.\n* The subject must have cytologically or histologically confirmed non-squamous NSCLC. Subjects may have a mixed histology but must be predominantly non-squamous to be eligible.\n* The subject must have advanced or metastatic (Stage IV \\[According to American Joint Committee on Cancer (AJCC) staging manual, 7th edition\\]) disease that is not amenable to surgical resection or radiation with curative intent.\n* The subject must have not received prior chemotherapy for NSCLC.\n* The subject has measurable disease, defined as at least 1 unidimensionally measurable lesion on a CT scan as defined by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.\n* The subject has an Easter Cooperative Oncology Group (ECOG) Performance Score of 0-1.\n* The subject must have adequate bone marrow, renal and hepatic function.\n\nExclusion Criteria\n\n* The subject has hypersensitivity to paclitaxel or to other drugs formulated with polyethoxylated castor oil (Cremophor).\n* The subject has received any anti-cancer therapy for treatment of NSCLC including investigational agents, immunotherapy, traditional Chinese medicine/herbal remedies, hormonal, "targeted" agents (i.e., erlotinib, imatinib), biologic therapy or cytotoxic chemotherapy (i.e., alkylating agents, microtubule inhibitors, antimetabolites).\n* The subject has a history of another active cancer within the past 5 years except cervical cancer in situ, in situ carcinoma of the bladder, squamous cell or basal cell carcinoma of the skin.\n* The subject has active ulcerative colitis, Crohn\'s disease, celiac disease or any other conditions that interfere with absorption.\n* The subject has a medical condition, which in the opinion of the study investigator places them at an unacceptably high risk for toxicities.\n* The subject is pregnant or breast feeding.\n* The subject has NSCLC with a predominant squamous cell histology.'}, 'identificationModule': {'nctId': 'NCT01225302', 'briefTitle': 'A Study of Linifanib (ABT-869) in Combination With Carboplatin/Paclitaxel in Japanese Subjects With Non-Small Cell Lung Cancer (NSCLC)', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': 'A Phase 1 Study of Linifanib (ABT-869) in Combination With Carboplatin/Paclitaxel in Japanese Subjects With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) as First-Line Treatment', 'orgStudyIdInfo': {'id': 'W12-076'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm A', 'interventionNames': ['Drug: Linifanib', 'Drug: Carboplatin', 'Drug: Paclitaxel']}, {'type': 'EXPERIMENTAL', 'label': 'Arm B', 'interventionNames': ['Drug: Linifanib', 'Drug: Carboplatin', 'Drug: Paclitaxel']}], 'interventions': [{'name': 'Linifanib', 'type': 'DRUG', 'otherNames': ['ABT-869'], 'description': 'Low dose linifanib (once a day)', 'armGroupLabels': ['Arm A']}, {'name': 'Linifanib', 'type': 'DRUG', 'otherNames': ['ABT-869'], 'description': 'High dose linifanib (once a day)', 'armGroupLabels': ['Arm B']}, {'name': 'Carboplatin', 'type': 'DRUG', 'otherNames': ['Paraplatin'], 'description': 'Given on Day 1 of every 21-day cycle', 'armGroupLabels': ['Arm A', 'Arm B']}, {'name': 'Paclitaxel', 'type': 'DRUG', 'otherNames': ['Taxol'], 'description': 'Given on Day 1 of every 21-day cycle', 'armGroupLabels': ['Arm A', 'Arm B']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Susumu Matsuki, BS', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Abbott Japan Co.,Ltd'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AbbVie', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}