Viewing Study NCT01745367

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Ignite Creation Date: 2025-12-25 @ 12:33 AM
Ignite Modification Date: 2026-02-18 @ 1:10 AM
Study NCT ID: NCT01745367
Status: TERMINATED
Last Update Posted: 2020-10-27
First Post: 2012-12-06
Is Gene Therapy: True
Has Adverse Events: True
Brief Title: Tivozanib in Combination With Paclitaxel in Patients With Locally Recurrent or Metastatic Triple Negative Breast Cancer
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Ghana', 'Thailand']}, 'conditionBrowseModule': {'meshes': [{'id': 'D064726', 'term': 'Triple Negative Breast Neoplasms'}, {'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': 'C553176', 'term': 'tivozanib'}, {'id': 'D017239', 'term': 'Paclitaxel'}], 'ancestors': [{'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': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Clinical@aveooncology.com', 'phone': '857-400-0101', 'title': 'Chief Medical Officer', 'organization': 'Aveo Pharmaceuticals, Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'The Sponsor terminated Study AV-951-12-204 before enrollment was completed after determining that enrollment of subjects was much lower than expected, and that timely completion of the study was not feasible.'}}, 'adverseEventsModule': {'timeFrame': '14 months', 'description': 'Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo in Combination With Paclitaxel', 'description': 'Participants received placebo orally once daily with 90 mg/m2 of paclitaxel administered intravenously beginning on Day 1 for 3 weeks followed by 1 week off treatment.', 'otherNumAtRisk': 8, 'otherNumAffected': 8, 'seriousNumAtRisk': 8, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Tivozanib Hydrochloride in Combination With Paclitaxel', 'description': 'Participants received 1.5 mg tivozanib hydrochloride orally once daily with 90 mg/m2 of paclitaxel administered intravenously beginning on Day 1 for 3 weeks followed by 1 week off treatment.', 'otherNumAtRisk': 21, 'otherNumAffected': 19, 'seriousNumAtRisk': 21, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 7}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pruritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pruritis Genralized', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Palmar-plantar erythrodysaesthesia syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Oral pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Faitgue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 11}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 8}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Blood lactate dehydrogenase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Liver function test abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Platelet count increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Blood thyroid stimulating hormone increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Lipase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Muscular weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Bone pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Peripheral sensory neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Neuropathy peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Rash pustular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Folliculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Rhinitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Upper-airway cough syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 9}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypomagnesaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Ocular hyperaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Infusion related reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Brain cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Metastasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dysuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pelvic pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Poor venous access', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 7}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Endocrine disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 3}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Brain cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Comparison of Progression-free Survival (PFS) of Subjects', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tivozanib Hydrochloride in Combination With Paclitaxel', 'description': '1.5 mg tivozanib hydrochloride orally once daily for 3 weeks followed by 1 week off and 90 mg/m2 of paclitaxel administered intravenously on weeks 1, 2 and 3 (Day 1, Day 8 and Day 15) of a 4-week cycle.'}, {'id': 'OG001', 'title': 'Placebo in Combination With Paclitaxel', 'description': 'Placebo orally once daily for 3 weeks followed by 1 week off and 90 mg/m2 of paclitaxel administered intravenously on weeks 1, 2 and 3 (Day 1, Day 8 and Day 15) of a 4-week cycle.'}], 'timeFrame': 'approximately 24 months', 'description': 'PFS is defined as the time from randomization to progressive disease (PD) or death. The PFS comparison was performed for subjects treated with tivozanib hydrochloride in combination with paclitaxel vs placebo in combination with paclitaxel.', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Comparison of Objective Response Rate (ORR) and Duration of Response (DoR) of Subjects', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tivozanib Hydrochloride in Combination With Paclitaxel', 'description': '1.5 mg tivozanib hydrochloride orally once daily for 3 weeks followed by 1 week off and 90 mg/m2 of paclitaxel administered intravenously on weeks 1, 2 and 3 (Day 1, Day 8 and Day 15) of a 4-week cycle.'}, {'id': 'OG001', 'title': 'Placebo in Combination With Paclitaxel', 'description': 'Placebo orally once daily for 3 weeks followed by 1 week off and 90 mg/m2 of paclitaxel administered intravenously on weeks 1, 2 and 3 (Day 1, Day 8 and Day 15) of a 4-week cycle.'}], 'timeFrame': 'approximately 24 months', 'description': 'ORR is defined as the proportion of patients with tumor size reduction of a predefined amount and for a minimum time period. 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'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'whyStopped': 'low enrollment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-05', 'studyFirstSubmitDate': '2012-12-06', 'resultsFirstSubmitDate': '2016-06-24', 'studyFirstSubmitQcDate': '2012-12-07', 'lastUpdatePostDateStruct': {'date': '2020-10-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-10-05', 'studyFirstPostDateStruct': {'date': '2012-12-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': 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The ORR and DoR comparison was performed for subjects treated with tivozanib hydrochloride in combination with paclitaxel vs placebo in combination with paclitaxel.'}, {'measure': 'Comparison of Overall Survival (OS) of Subjects', 'timeFrame': 'approximately 24 months', 'description': 'OS measures how long subjects, who undergo a certain treatment regimen, live compared to subjects who are in a control group (i.e., taking either another drug or an inactive treatment, known as a placebo). OS comparison was performed for subjects treated with tivozanib hydrochloride in combination with paclitaxel vs placebo in combination with paclitaxel.'}, {'measure': 'Safety and Tolerability of Tivozanib Hydrochloride in Combination With Paclitaxel vs Placebo in Combination With Paclitaxel', 'timeFrame': 'approximately 24 months', 'description': 'Number of subjects with serious and non-serious adverse events.'}, {'measure': 'Pharmacokinetics (PK) of Tivozanib Hydrochloride and Paclitaxel When Administered in Combination', 'timeFrame': 'approximately 24 months', 'description': 'PK is defined as the study of the bodily absorption, distribution, metabolism, and excretion of drugs.'}, {'measure': 'Identification of Hypoxia Gene Signature', 'timeFrame': 'Cycle 1, Day 1: Pre-dose and 2, 4 and 24 hours post dose; Cycle 1, Day 8: Pre-dose; Cycle 1, Day 21: Pre-dose and 2, 4, 24, 48, and 96 hours post dose; Cycle 2 (Day 1): Pre-dose', 'description': 'Evaluation of hypoxia gene signature as a predictive biomarker of tivozanib hydrochloride response and establish the optimal cut-off to identify biomarker positive and negative subgroups. The genes comprising the hypoxia gene signature was analyzed in tumor tissue from subjects.'}, {'measure': "Measurement of Subjects' Quality of Life (QoL)", 'timeFrame': 'approximately 24 months', 'description': "The Functional Assessment of Cancer Therapy-Breast (FACT-B) and Euro Quality of Life - 5 Dimensions (EQ-5D) questionnaires was used throughout the study to measure subjects' health-related QoL."}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Tivozanib hydrochloride', 'triple negative breast cancer', 'paclitaxel', 'pharmacokinetics', 'biomarkers', 'metastatic breast cancer', 'mBC', 'TNBC'], 'conditions': ['Triple Negative Breast Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://aveooncology.com', 'label': 'Aveo Pharmaceuticals, Inc. official web page'}]}, 'descriptionModule': {'briefSummary': 'This is a phase 2 multicenter, double-blind, randomized, placebo-controlled, two-arm study for subjects with locally recurrent or metastatic triple negative breast cancer.', 'detailedDescription': 'This is a phase 2 multicenter, double-blind, randomized, placebo-controlled, two-arm study for subjects with locally recurrent or metastatic triple negative breast cancer.\n\nPatients will be randomized 2:1 to either tivozanib hydrochloride and weekly paclitaxel or placebo and weekly paclitaxel.\n\nSubjects will be stratified based on Eastern Cooperative Oncology Group (ECOG) performance score (0 vs 1) and line of treatment (first vs second).\n\nAll subjects will be evaluated for progression free survival and overall survival as well as safety and tolerability. Biomarker and pharmacokinetic (PK) analysis are also included in study. This study will determine whether tivozanib hydrocholoride combined with weekly paclitaxel improves clinical outcomes in patients with triple negative breast cancer.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Locally recurrent or metastatic TNBC, defined as ER/PR \\<1%, HER2 0-1+, or 2+ with negative FISH\n* Measurable disease per RECIST version 1.1\n* ECOG performance status of 0 or 1\n* Confirmed available archival tumor tissue.\n\nExclusion Criteria:\n\n* More than 1 prior systemic chemotherapy for treatment of locally recurrent or metastatic breast cancer (neoadjuvant and adjuvant therapy is allowed provided the subject did not progress within 12 months of taxane based therapy\n* Prior treatment with VEGF pathway targeted agent\n* Major surgery within 4 weeks or minor surgery or radiotherapy within 2 weeks of first dose of study drug\n* Known history of central nervous system metastasis (subjects with previously treated (radiotherapy or surgery) brain metastasis that have been stable off steroids or enzyme-inducing antiepileptic drugs for at least 3 months following prior treatment may be enrolled)\n* Significant hematologic, gastrointestinal, thromboembolic, vascular, bleeding, or coagulation disorders\n* Significant serum chemistry or urinalysis abnormalities\n* Significant cardiovascular disease, including: uncontrolled hypertension; myocardial infarction or unstable angina within 6 months prior to administration of first dose of study drug; and symptomatic left ventricular dysfunction or baseline left ventricular ejection fraction (LVEF) by multigated acquisition scan (MUGA) or ECHO.\n* Severe peripheral neuropathy ≥ Grade 2\n* Currently active second primary malignancy'}, 'identificationModule': {'nctId': 'NCT01745367', 'acronym': 'BATON-BC', 'briefTitle': 'Tivozanib in Combination With Paclitaxel in Patients With 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