Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2025-12-26 @ 1:06 AM
Study NCT ID:
NCT00825734
Status:
COMPLETED
Last Update Posted:
2014-12-22
First Post:
2009-01-19
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Phase I/II Trial of Sorafenib Plus Ixabepilone in HER2-Negative Metastatic Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077157', 'term': 'Sorafenib'}, {'id': 'C430592', 'term': 'ixabepilone'}], 'ancestors': [{'id': 'D010671', 'term': 'Phenylurea Compounds'}, {'id': 'D014508', 'term': 'Urea'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009536', 'term': 'Niacinamide'}, {'id': 'D009539', 'term': 'Nicotinic Acids'}, {'id': 'D000147', 'term': 'Acids, Heterocyclic'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'asksarah@scresearch.net', 'phone': '1-877-691-7274', 'title': 'John D. Hainsworth, MD', 'organization': 'Sarah Cannon Research Institute'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Dose Level 1a', 'description': 'Includes patients treated at the Phase II dose - Sorafenib PO BID (400mg), Ixabepilone IV every 21 days (32mg/m\\^2)', 'otherNumAtRisk': 76, 'otherNumAffected': 75, 'seriousNumAtRisk': 76, 'seriousNumAffected': 6}], 'otherEvents': [{'term': 'ABDOMINAL PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 41, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v 4.0'}, {'term': 'ALKALINE PHOSPHATASE INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 16, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v 4.0'}, {'term': 'ALLERGIC REACTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 11, 'numAffected': 10}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v 4.0'}, {'term': 'ALLERGIC RHINITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 26, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v 4.0'}, {'term': 'ALOPECIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 174, 'numAffected': 31}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v 4.0'}, {'term': 'ANEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 119, 'numAffected': 27}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v 4.0'}, {'term': 'ANOREXIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 76, 'numAffected': 28}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v 4.0'}, {'term': 'ANXIETY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 23, 'numAffected': 6}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v 4.0'}, {'term': 'ARTHRALGIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 106, 'numAffected': 29}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v 4.0'}, {'term': 'ASTHENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 99, 'numAffected': 14}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v 4.0'}, {'term': 'BACK PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 49, 'numAffected': 13}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v 4.0'}, {'term': 'BONE PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 19, 'numAffected': 8}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v 4.0'}, {'term': 'CALLUS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 41, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v 4.0'}, {'term': 'CHEST PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 26, 'numAffected': 14}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v 4.0'}, {'term': 'CHILLS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 7, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v 4.0'}, {'term': 'CONSTIPATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 56, 'numAffected': 24}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v 4.0'}, {'term': 'COUGH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 55, 'numAffected': 19}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v 4.0'}, {'term': 'DEHYDRATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v 4.0'}, {'term': 'DEPRESSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 31, 'numAffected': 7}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v 4.0'}, {'term': 'DESQUAMATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 11, 'numAffected': 6}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v 4.0'}, {'term': 'DIARRHEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 126, 'numAffected': 35}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v 4.0'}, {'term': 'DIZZINESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 43, 'numAffected': 12}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v 4.0'}, {'term': 'DRY MOUTH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 17, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v 4.0'}, {'term': 'DRY SKIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 58, 'numAffected': 9}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v 4.0'}, {'term': 'DYSPEPSIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 35, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v 4.0'}, {'term': 'DYSPHAGIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v 4.0'}, {'term': 'DYSPNEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 79, 'numAffected': 23}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v 4.0'}, {'term': 'EDEMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 36, 'numAffected': 15}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v 4.0'}, {'term': 'EPISTAXIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 10, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v 4.0'}, {'term': 'ERYTHEMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 11, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v 4.0'}, {'term': 'FATIGUE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 274, 'numAffected': 61}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v 4.0'}, {'term': 'FEVER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 19, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v 4.0'}, {'term': 'FLANK PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 7, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v 4.0'}, {'term': 'FLUSHING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 10, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v 4.0'}, {'term': 'GASTROESOPHAGEAL REFLUX DISEASE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 17, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v 4.0'}, {'term': 'HEADACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 29, 'numAffected': 13}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v 4.0'}, {'term': 'HOT FLASHES', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 18, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v 4.0'}, {'term': 'HYPERGLYCEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 31, 'numAffected': 8}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v 4.0'}, {'term': 'HYPERTENSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 104, 'numAffected': 26}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v 4.0'}, {'term': 'HYPOKALEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 21, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v 4.0'}, {'term': 'HYPOTENSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v 4.0'}, {'term': 'INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 10, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v 4.0'}, {'term': 'INSOMNIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 63, 'numAffected': 11}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v 4.0'}, {'term': 'LEUKOPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 114, 'numAffected': 32}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v 4.0'}, {'term': 'LYMPHEDEMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 8, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v 4.0'}, {'term': 'MUCOSITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 23, 'numAffected': 13}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v 4.0'}, {'term': 'MYALGIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 42, 'numAffected': 15}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v 4.0'}, {'term': 'NASAL CONGESTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 12, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v 4.0'}, {'term': 'NASAL DRAINAGE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 8, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v 4.0'}, {'term': 'NAUSEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 141, 'numAffected': 39}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v 4.0'}, {'term': 'NEUTROPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 115, 'numAffected': 36}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v 4.0'}, {'term': 'PAIN IN EXTREMITY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 88, 'numAffected': 23}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v 4.0'}, {'term': 'PALMAR-PLANTAR ERYTHRODYSESTHESIA SYNDROME', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 46, 'numAffected': 12}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v 4.0'}, {'term': 'PERIPHERAL NEUROPATHY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 255, 'numAffected': 41}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v 4.0'}, {'term': 'PRURITUS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 21, 'numAffected': 10}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v 4.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 16, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v 4.0'}, {'term': 'RASH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 158, 'numAffected': 41}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v 4.0'}, {'term': 'SINUSITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 11, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v 4.0'}, {'term': 'SORE THROAT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 11, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v 4.0'}, {'term': 'TACHYCARDIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 19, 'numAffected': 6}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v 4.0'}, {'term': 'TASTE ALTERATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 50, 'numAffected': 10}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v 4.0'}, {'term': 'THROMBOCYTOPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 65, 'numAffected': 23}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v 4.0'}, {'term': 'UPPER RESPIRATORY INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 7, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v 4.0'}, {'term': 'VOMITING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 37, 'numAffected': 20}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v 4.0'}, {'term': 'WEIGHT LOSS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 23, 'numAffected': 11}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v 4.0'}], 'seriousEvents': [{'term': 'ACUTE RENAL FAILURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v 4.0'}, {'term': 'ANEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v 4.0'}, {'term': 'BACK PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 3, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v 4.0'}, {'term': 'DEATH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v 4.0'}, {'term': 'DYSPNEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v 4.0'}, {'term': 'INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v 4.0'}, {'term': 'PALMAR-PLANTAR ERYTHRODYSESTHESIA SYNDROME', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v 4.0'}, {'term': 'PNEUMONIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v 4.0'}, {'term': 'RASH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v 4.0'}, {'term': 'WEIGHT LOSS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v 4.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Progression-Free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sorafenib and Ixabepilone', 'description': 'Oral targeted therapy and Systemic Chemotherapy'}], 'classes': [{'categories': [{'measurements': [{'value': '4.8', 'groupId': 'OG000', 'lowerLimit': '3.5', 'upperLimit': '6.3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'every 9 weeks until treatment discontinuation or death on study', 'description': 'Measured from Day 1 of study drug administration to disease progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST) - progression is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes patients treated at the Phase II dose'}, {'type': 'SECONDARY', 'title': '6-month Progression-Free Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sorafenib and Ixabepilone', 'description': 'Oral targeted therapy and Systemic Chemotherapy'}], 'classes': [{'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'every 9 weeks, up to 6 months', 'description': 'Measured from Day 1 of study drug administration to disease progression as defined by RECIST v1.1, or death on study. Progression is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes patients treated at the Phase II dose'}, {'type': 'SECONDARY', 'title': 'Objective Response Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sorafenib and Ixabepilone', 'description': 'Oral targeted therapy and Systemic Chemotherapy'}], 'classes': [{'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'every 9 weeks until discontinuation of treatment', 'description': 'Objective Response will be evaluated in this study using the Response Evaluation Criteria in Solid Tumors (RECIST).', 'unitOfMeasure': 'patients', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes patients treated at the Phase II dose who were evaluable for response'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sorafenib and Ixabepilone', 'description': 'Oral targeted therapy and Systemic Chemotherapy'}], 'classes': [{'categories': [{'measurements': [{'value': '15.5', 'groupId': 'OG000', 'lowerLimit': '11', 'upperLimit': '20.6'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'every 9 weeks until treatment discontinuation or death on study', 'description': 'Measured from Day 1 of study drug administration to date of death due to any cause.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes patients treated at the Phase II dose'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Adverse Events as a Measure of of Safety and Tolerability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase II - Sorafenib and Ixabepilone', 'description': 'Oral targeted therapy and Systemic Chemotherapy'}], 'classes': [{'title': 'Neutropenia', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}]}]}, {'title': 'Febrile neutropenia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Anemia', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}]}]}, {'title': 'Thrombocytopenia', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}]}]}, {'title': 'Fatigue', 'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000'}]}]}, {'title': 'Nausea/vomiting', 'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000'}]}]}, {'title': 'Rash', 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}]}]}, {'title': 'Neuropathy', 'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}]}]}, {'title': 'Anorexia/weight loss', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}]}]}, {'title': 'Diarrhea', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}]}]}, {'title': 'Arthralgia/myalgia', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}]}]}, {'title': 'Alopecia', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}]}]}, {'title': 'Pain in extremity', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}]}]}, {'title': 'Hypertension', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}]}]}, {'title': 'Constipation', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}, {'title': 'Dyspnea', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}, {'title': 'Hand-foot syndrome', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}, {'title': 'Taste alteration', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': 'Mucositis', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': 'Pruritus', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'every 9 weeks until treatment discontinuation or unacceptable toxicity', 'description': 'Assessments are made through analysis of reported incidence of treatment-emergent AEs and SAEs.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients treated at the Phase II dose'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Dose Level 1', 'description': 'Sorafenib PO BID (200mg), Ixabepilone IV every 21 days (40mg/m\\^2)'}, {'id': 'FG001', 'title': 'Dose Level -1', 'description': 'Sorafenib PO BID (200mg), Ixabepilone IV every 21 days (32mg/m\\^2)'}, {'id': 'FG002', 'title': 'Dose Level 1a', 'description': 'Sorafenib PO BID (400mg), Ixabepilone IV every 21 days (32mg/m\\^2)'}], 'periods': [{'title': 'Phase I', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Patients were on-study until determination of the Maximum Tolerated Dose (MTD)', 'groupId': 'FG000', 'numSubjects': '0'}, {'comment': 'Patients were on-study until determination of the Maximum Tolerated Dose (MTD)', 'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Phase II', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'comment': 'Includes patients treated at MTD during Phase I and 73 additional patients enrolled for Phase II', 'groupId': 'FG002', 'numSubjects': '76'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '76'}]}]}], 'recruitmentDetails': 'Patients were recruited at multiple dose levels into the Dose Escalation (Phase I) portion of this study to determine the safest dose of this regimen (MTD-Maximum Tolerated Dose). Upon determination of this dose, patients being treated at the MTD proceeded to the Dose Expansion (Phase II) portion of the study and additional patients were recruited'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Patients', 'description': 'Patients treated at all dose levels in the Phase I and Phase II portions of the study\n\n: Dose Level 1 (4 patients) Sorafenib PO BID (200mg), Ixabepilone IV every 21 days (40mg/m\\^2)\n\nDose Level -1 (3 patients) Sorafenib PO BID (200mg), Ixabepilone IV every 21 days (32mg/m\\^2)\n\nDose Level 1a (76 patients) Sorafenib PO BID (400mg), Ixabepilone IV every 21 days (32mg/m\\^2)'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57', 'groupId': 'BG000', 'lowerLimit': '30', 'upperLimit': '80'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '82', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '83', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 83}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-16', 'studyFirstSubmitDate': '2009-01-19', 'resultsFirstSubmitDate': '2014-11-21', 'studyFirstSubmitQcDate': '2009-01-19', 'lastUpdatePostDateStruct': {'date': '2014-12-22', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-12-16', 'studyFirstPostDateStruct': {'date': '2009-01-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-12-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-Free Survival (PFS)', 'timeFrame': 'every 9 weeks until treatment discontinuation or death on study', 'description': 'Measured from Day 1 of study drug administration to disease progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST) - progression is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions'}], 'secondaryOutcomes': [{'measure': '6-month Progression-Free Survival', 'timeFrame': 'every 9 weeks, up to 6 months', 'description': 'Measured from Day 1 of study drug administration to disease progression as defined by RECIST v1.1, or death on study. Progression is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions'}, {'measure': 'Objective Response Rate', 'timeFrame': 'every 9 weeks until discontinuation of treatment', 'description': 'Objective Response will be evaluated in this study using the Response Evaluation Criteria in Solid Tumors (RECIST).'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'every 9 weeks until treatment discontinuation or death on study', 'description': 'Measured from Day 1 of study drug administration to date of death due to any cause.'}, {'measure': 'Number of Patients With Adverse Events as a Measure of of Safety and Tolerability', 'timeFrame': 'every 9 weeks until treatment discontinuation or unacceptable toxicity', 'description': 'Assessments are made through analysis of reported incidence of treatment-emergent AEs and SAEs.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Metastatic Breast Cancer', 'Sorafenib', 'Nexavar', 'Ixabepilone', 'Ixempra'], 'conditions': ['Metastatic Breast Cancer']}, 'descriptionModule': {'briefSummary': 'In this study, patients with metastatic HER2-negative breast cancer will receive treatment with ixabepilone and sorafenib until disease progression or unacceptable toxicity occurs. The Phase I portion of this study will determine the maximum tolerated doses (MTDs) of sorafenib and ixabepilone that may be used in combination for first- or second-line treatment of MBC. The MTDs identified in the Phase I portion of the study will be used in the Phase II portion which will evaluate the efficacy and safety of the combination of sorafenib and ixabepilone in patients who have received at least one prior chemotherapy treatment in either the adjuvant or neoadjuvant setting or following one prior MBC chemotherapy in MBC patients who had not received prior adjuvant or neoadjuvant breast cancer chemotherapy. This will be one of the initial trials investigating the use of this treatment combination for MBC.\n\nThis trial will be conducted under the leadership of the Sarah Cannon Research Institute (SCRI) Oncology Research Consortium, a community-based, multi-center, clinical trial organization.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Age ≥ 18 years.\n2. Histologically or cytologically confirmed breast cancer diagnosis\n\nwith metastatic disease. Patients without pathologic or cytologic\n\nconfirmation of metastatic disease should have unequivocal\n\nevidence of metastasis.\n\n3\\. Measurable disease, as per RECIST criteria (Therasse et al.\n\n2000). Measurable disease cannot be previously irradiated\n\nunless progression was documented. Measurable disease is\n\ndefined as: at least one lesion that can be accurately measured in\n\nat least one dimension \\[longest diameter to be recorded\\] as\n\n\\>20 mm with conventional techniques, or as \\>10 mm with spiral\n\ncomputed tomography (CT) scan. Disease must be measurable,\n\ni.e., bone-only disease or evaluable-only disease is not eligible.\n\n4\\. Patients with brain metastasis may participate if they:\n\n• have undergone appropriate treatment,\n\n* are at least 1 month post-treatment,\n* have no neurologic symptoms,\n* are not on steroids,\n* have a follow-up magnetic resonance imaging (MRI) scan that\n\ndemonstrates no residual active lesions, and\n\n* have no new untreated lesions.\n\n 5 The following prior therapies are allowed:\n* No prior chemotherapy in the metastatic setting. However,\n\npatients must have received prior adjuvant or neo-adjuvant\n\nchemotherapy.\n\n* Prior radiation therapy in either the metastatic or early-stage\n\nsetting, as long as \\<25% of the bone marrow has been\n\ntreated. Radiation therapy must be completed at least\n\n14 days prior to study registration, and all radiation-related\n\ntoxicities must be resolved to ≤ grade 1 before the patient is\n\neligible for study inclusion.\n\n* Any number of hormonal therapies in the neo-adjuvant,\n\nadjuvant, or metastatic setting is allowed. Patients must\n\ndiscontinue hormonal therapy at least 1 week prior to starting\n\nstudy treatment.\n\n•Prior bevacizumab administered \\>4 weeks before initiation of\n\nstudy treatment is allowed.\n\n6 HER2-negative status. Documentation of HER2 results must be\n\navailable at the time of study enrollment. HER2-negative is\n\ndefined as:\n\n* Immunohistochemical (IHC) 0 or IHC 1+ OR\n* Fluorescence in situ hybridization (FISH) negative (defined by\n\nFISH ratio \\<2.2) OR\n\n* Silver in-situ hybridization (SISH) negative (defined by SISH\n\nratio \\<2.2).\n\nPatients with an IHC 2+ will need to be validated as HER2-negative\n\nby FISH.\n\n7 An Eastern Cooperative Oncology Group (ECOG) performance\n\nstatus of \\< or = to 2.\n\n8\\. Normal bone marrow function as defined by:\n\n* absolute neutrophil count (ANC) \\>1,500/μL;\n* platelets \\>100,000/μL;\n* hemoglobin \\>9 g/dL.\n\n 9 Normal hepatic function as defined by:\n* total bilirubin within normal institutional limits;\n* aspartate aminotransferase (AST) and alanine\n\naminotransferase (ALT) \\<2.5 × the institutional upper limit of\n\nnormal (ULN) for patients without liver metastasis; \\<5.0 × ULN\n\nfor patients with liver metastasis.\n\n10\\. Normal renal function as defined by creatinine \\<1.5 × ULN.\n\n11\\. Left ventricular ejection fraction (LVEF) within institutional limits of\n\nnormal.\n\n12\\. International normalized ratio (INR) \\<1.5 or a prothrombin\n\ntime/partial thromboplastin time (PT/PTT) within normal limits.\n\nPatients receiving anti-coagulation treatment with an agent such\n\nas warfarin or heparin may be allowed to participate. The INR\n\nshould be measured prior to initiation of sorafenib, and for\n\npatients on warfarin, INR should be monitored at least weekly\n\nfollowing initiation of protocol treatment, until the INR is stable and\n\ntherapeutic.\n\n13\\. Life expectancy of \\>6 months.\n\n14\\. For women of childbearing potential, negative serum pregnancy\n\ntest within 7 days prior to starting treatment.\n\n15\\. For women of childbearing potential and men, agreement to use a\n\nmethod of contraception that is acceptable to their physician from\n\ntime of first signing the informed consent and for the study\n\nduration. Men should use adequate birth control for at least three\n\nmonths after the last administration of sorafenib. If a woman\n\nbecomes pregnant or suspects she is pregnant while participating\n\nin this study, she must agree to inform her treating physician\n\nimmediately. As applicable, patients must agree to discontinue\n\nbreast-feeding until at least 3 weeks after their last dose of study\n\ndrug.\n\n16\\. Recovery to \\< grade 1 toxicity due to prior therapy.\n\n17\\. Ability to understand and willingness to sign a written informed\n\nconsent document.\n\nExclusion Criteria\n\n1. More than one (\\>1) prior chemotherapy regimen.\n2. Treatment with chemotherapy, biologic agents, or targeted agents\n\n within the previous 4 weeks.\n3. Previous treatment with sorafenib or ixabepilone.\n4. Women who are pregnant or breastfeeding.\n5. Neuropathy (motor or sensory) greater than grade 1.\n6. Uncontrolled intercurrent illness including (but not limited to)\n\n ongoing or active infection \\>grade 2.\n7. Known history of human immunodeficiency virus (HIV), Hepatitis\n\n B, or Hepatitis C infection.\n8. History of other non-breast cancer malignancy treated with\n\n curative intent within the 5 years preceding study enrollment with\n\n the exception of carcinoma in situ of the cervix, non-melanoma\n\n skin cancer, or follicular thyroid cancer.\n9. Concurrent hormonal therapy, chemotherapy other than\n\n ixabepilone, or radiation treatments while on study as well as\n\n treatment with other investigational agents while on study.\n10. Cardiac disease:\n\n •Congestive heart failure (CHF) greater than New York Heart Association\n\n (NYHA) Class II (see Appendix B).\n * Unstable angina (anginal symptoms at rest) or new onset angina\n\n (i.e., began within the last 3 months).\n * Myocardial infarction within the past 6 months.\n * Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy.\n11. Uncontrolled hypertension (systolic blood pressure \\>150 mmHg\n\n or diastolic pressure \\>100 mmHg despite optimal medical\n\n management).\n12. Thrombolic or embolic events such as cerebrovascular accident,\n\n including transient ischemic attacks, within the past 6 months.\n13. Pulmonary hemorrhage or bleeding event ≥ grade 2 within\n\n4 weeks of the first dose of study treatment, or any other\n\nhemorrhage or bleeding event ≥ grade 3 within 4 weeks of the\n\nfirst dose of study treatment.\n\n14\\. Serious non-healing wound, ulcer, or bone fracture.\n\n15\\. Evidence or history of bleeding diathesis or coagulopathy.\n\n16\\. Major surgery, open biopsy or significant traumatic injury within\n\n4 weeks of the first dose of study drugs or anticipation of the need\n\nfor major surgical procedure.\n\n17\\. Chronic use of CYP3A4 inducers and use of the following strong\n\nCYP3A4 inhibitors: ketoconazole, itraconazole, clarithromycin,\n\natazanavir, nefazodone, saquinavir, telithromycin, ritonavir,\n\namprenavir, indinavir, nelfinavir, delavirdine, and voriconazole.\n\nUse of these agents should be discontinued at least 72 hours\n\nprior to initiation of study treatment.\n\n18\\. Use of St. John's Wort or rifampin (rifampicin).\n\n19\\. Any condition that impairs patient's ability to swallow whole pills or\n\ngastrointestinal (GI) tract disease that involves an inability to take\n\noral medication, malabsorption syndrome, a requirement for\n\nintravenous (IV) alimentation, prior surgical procedures affecting\n\nabsorption, or uncontrolled inflammatory GI disease (e.g., Crohn's\n\ndisease or ulcerative colitis).\n\n20\\. Psychiatric illness/social situations that would limit compliance\n\nwith study requirements.\n\n21\\. Known or suspected allergy to sorafenib, Cremophor EL\n\n(polyoxyethylated castor oil) or a drug formulated in\n\nCremophor EL such as paclitaxel or any other agent given in the\n\ncourse of this trial.\n\nExclusion Criteria:"}, 'identificationModule': {'nctId': 'NCT00825734', 'briefTitle': 'Phase I/II Trial of Sorafenib Plus Ixabepilone in HER2-Negative Metastatic Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'SCRI Development Innovations, LLC'}, 'officialTitle': 'Phase I/II Trial of Sorafenib Plus Ixabepilone in HER2-Negative Metastatic Breast Cancer (MBC)', 'orgStudyIdInfo': {'id': 'SCRI BRE 138'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dose Level 1', 'description': 'Sorafenib PO BID (200mg), Ixabepilone IV every 21 days (40mg/m\\^2)', 'interventionNames': ['Drug: Sorafenib', 'Drug: Ixabepilone']}, {'type': 'EXPERIMENTAL', 'label': 'Dose Level -1', 'description': 'Sorafenib PO BID (200mg), Ixabepilone IV every 21 days (32mg/m\\^2)', 'interventionNames': ['Drug: Sorafenib', 'Drug: Ixabepilone']}, {'type': 'EXPERIMENTAL', 'label': 'Dose Level 1a', 'description': 'Sorafenib PO BID (400mg), Ixabepilone IV every 21 days (32mg/m\\^2)', 'interventionNames': ['Drug: Sorafenib', 'Drug: Ixabepilone']}], 'interventions': [{'name': 'Sorafenib', 'type': 'DRUG', 'otherNames': ['Nexavar (Sorafenib)'], 'description': 'Dose Level 1 - Sorafenib PO BID (200mg) Dose Level -1 - Sorafenib PO BID (200mg) Dose Level 1a - Sorafenib PO BID (400mg)', 'armGroupLabels': ['Dose Level -1', 'Dose Level 1', 'Dose Level 1a']}, {'name': 'Ixabepilone', 'type': 'DRUG', 'otherNames': ['Ixempra (Ixabepilone)'], 'description': 'Dose Level 1 - Ixabepilone IV every 21 days (40mg/m\\^2) Dose Level -1 - Ixabepilone IV every 21 days (32mg/m\\^2) Dose Level 1a - Ixabepilone IV every 21 days (32mg/m\\^2)', 'armGroupLabels': ['Dose Level -1', 'Dose Level 1', 'Dose Level 1a']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33916', 'city': 'Fort Myers', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Cancer Specialists', 'geoPoint': {'lat': 26.62168, 'lon': -81.84059}}, {'zip': '47802', 'city': 'Terre Haute', 'state': 'Indiana', 'country': 'United States', 'facility': 'Providence Medical Group', 'geoPoint': {'lat': 39.4667, 'lon': -87.41391}}, {'zip': '47802', 'city': 'Terre Haute', 'state': 'Indiana', 'country': 'United States', 'facility': 'RHHP/ Hope Cancer Center', 'geoPoint': {'lat': 39.4667, 'lon': -87.41391}}, {'zip': '40207', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Baptist Hospital East', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '70806', 'city': 'Baton Rouge', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Hematology Oncology Clinic, LLP', 'geoPoint': {'lat': 30.44332, 'lon': -91.18747}}, {'zip': '04101', 'city': 'Portland', 'state': 'Maine', 'country': 'United States', 'facility': 'Mercy Hospital', 'geoPoint': {'lat': 43.65737, 'lon': -70.2589}}, {'zip': '20817', 'city': 'Bethesda', 'state': 'Maryland', 'country': 'United States', 'facility': 'Center for Cancer and Blood Disorders', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}, {'zip': '20817', 'city': 'Bethesda', 'state': 'Maryland', 'country': 'United States', 'facility': 'National Capital Clinical Research Consortium', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}, {'zip': '63044', 'city': 'Chesterfield', 'state': 'Missouri', 'country': 'United States', 'facility': 'St. Louis Cancer Care', 'geoPoint': {'lat': 38.66311, 'lon': -90.57707}}, {'zip': '03801', 'city': 'Portsmouth', 'state': 'New Hampshire', 'country': 'United States', 'facility': 'Portsmouth Regional Hospital', 'geoPoint': {'lat': 43.07704, 'lon': -70.75766}}, {'zip': '07962', 'city': 'Morristown', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Hematology-Oncology Associates of Northern NJ', 'geoPoint': {'lat': 40.79677, 'lon': -74.48154}}, {'zip': '45242', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Oncology Hematology Care', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '29210', 'city': 'Columbia', 'state': 'South Carolina', 'country': 'United States', 'facility': 'South Carolina Oncology Associates', 'geoPoint': {'lat': 34.00071, 'lon': -81.03481}}, {'city': 'Spartanburg', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Spartanburg Regional Medical Center', 'geoPoint': {'lat': 34.94957, 'lon': -81.93205}}, {'zip': '37023', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Tennessee Oncology, PLLC', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'overallOfficials': [{'name': 'Denise A. Yardley, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'SCRI Development Innovations, LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'SCRI Development Innovations, LLC', 'class': 'OTHER'}, 'collaborators': [{'name': 'Bayer', 'class': 'INDUSTRY'}, {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}