Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2025-12-26 @ 6:02 PM
Study NCT ID:
NCT00716534
Status:
COMPLETED
Last Update Posted:
2013-04-29
First Post:
2008-07-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Carboplatin/Paclitaxel in Combination With ABT-869 in Subjects With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)
Sponsor:
Organization:
Raw JSON
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Randomized phase II study of carboplatin and paclitaxel with either linifanib or placebo for advanced nonsquamous non-small-cell lung cancer. J Clin Oncol. 2015 Feb 10;33(5):433-41. doi: 10.1200/JCO.2014.55.7173. Epub 2015 Jan 5.'}]}, 'descriptionModule': {'briefSummary': 'This study is designed to determine the clinical efficacy and toxicity of ABT-869 in combination with carboplatin and paclitaxel in the treatment of subjects with advanced or metastatic NSCLC.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subject must be at least 18 years of age.\n* Subject must have cytologically or histologically confirmed non-squamous NSCLC\n* Subject must have recurrent or advanced (Stage IIIb with pleural or pericardial effusion) or metastatic (Stage IV) disease that is not amenable to surgical resection or radiation with curative intent.\n* Subject has measurable disease, defined as at least 1 unidimensional measurable lesion on a computed tomography (CT) scan as defined by RECIST (for subjects in the randomized portion only).\n* Subject has an ECOG Performance Score of 0-1.\n* Willing to take adequate measures to prevent pregnancy.\n\nExclusion Criteria:\n\n* The subject has NSCLC with a predominant squamous cell histology\n* Subject has hypersensitivity to paclitaxel.\n* Subject has received any anti-cancer therapy for treatment of NSCLC.\n* Subject has received radiation therapy within 21 days of Study Day 1.\n* Subject has had major surgery within 21 days.\n* Subject has untreated brain or meningeal metastases.\n* Subject is receiving therapeutic anticoagulation therapy.\n* Subject has a central thoracic tumor lesion as defined by location within the hilar structures.\n* Subject has proteinuria CTC Grade \\> 1 at baseline.\n* Subject has a history of, or currently exhibits clinically significant cancer related events of bleeding.\n* The subject currently exhibits symptomatic or persistent, uncontrolled hypertension defined as diastolic blood pressure (BP) \\> 90 mm Hg or systolic BP \\> 140 mm Hg.\n* The subject has a history of myocardial infarction, stroke or Transient Ischemic Attack (TIA) within 6 months of Study Day 1.\n* The subject has a documented left ventricular (LV) ejection fraction \\< 50%.\n* The subject has known autoimmune disease with renal involvement (i.e., lupus).\n* The subject is receiving combination anti-retroviral therapy for HIV.\n* The subject has clinically significant uncontrolled condition(s).\n* The subject has a history of another active cancer within the past 5 years.\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."}, 'identificationModule': {'nctId': 'NCT00716534', 'briefTitle': 'Study of Carboplatin/Paclitaxel in Combination With ABT-869 in Subjects With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': 'A Phase 2 Randomized, Placebo-Controlled, Double-Blind Study of Carboplatin/Paclitaxel in Combination With ABT-869 Versus Carboplatin/Paclitaxel Alone in Subjects With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) as First-Line Treatment', 'orgStudyIdInfo': {'id': 'M10-301'}, 'secondaryIdInfos': [{'id': '2007-007107-32', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'description': '12.5 mg ABT-869 + Carboplatin/Paclitaxel', 'interventionNames': ['Drug: ABT-869', 'Drug: Carboplatin', 'Drug: Paclitaxel']}, {'type': 'EXPERIMENTAL', 'label': 'B', 'description': '7.5 mg ABT-869 + Carboplatin/Paclitaxel', 'interventionNames': ['Drug: ABT-869', 'Drug: Carboplatin', 'Drug: Paclitaxel']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'C', 'description': 'Placebo (7.5 mg or 12.5 mg) + Carboplatin/Paclitaxel', 'interventionNames': ['Drug: Placebo for 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