Tivozanib in Combination With Paclitaxel in Patients With Locally Recurrent or Metastatic Triple Negative Breast Cancer
NCT ID: NCT01745367
Last Updated: 2020-10-27
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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TERMINATED
PHASE2
30 participants
INTERVENTIONAL
2012-11-30
2014-06-30
Brief Summary
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Detailed Description
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Patients will be randomized 2:1 to either tivozanib hydrochloride and weekly paclitaxel or placebo and weekly paclitaxel.
Subjects will be stratified based on Eastern Cooperative Oncology Group (ECOG) performance score (0 vs 1) and line of treatment (first vs second).
All 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Placebo in combination with paclitaxel
Placebo orally once daily on a 3 weeks on/1 week off schedule with 90 mg/m2 of paclitaxel administered intravenously 3 weeks on (Day 1, Day 8 and Day 15)/1 week off (4 weeks = 1 Cycle).
paclitaxel
Placebo
Tivo in combination with paclitaxel
1.5 mg tivozanib hydrochloride orally once daily on a 3 weeks on/1 week off schedule with 90 mg/m2 of paclitaxel administered intravenously 3 weeks on (Day 1, Day 8 and Day 15)/1 week off (4 weeks = 1 Cycle).
Tivozanib Hydrochloride
paclitaxel
Interventions
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Tivozanib Hydrochloride
paclitaxel
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Measurable disease per RECIST version 1.1
* ECOG performance status of 0 or 1
* Confirmed available archival tumor tissue.
Exclusion Criteria
* Prior treatment with VEGF pathway targeted agent
* Major surgery within 4 weeks or minor surgery or radiotherapy within 2 weeks of first dose of study drug
* 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)
* Significant hematologic, gastrointestinal, thromboembolic, vascular, bleeding, or coagulation disorders
* Significant serum chemistry or urinalysis abnormalities
* 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.
* Severe peripheral neuropathy ≥ Grade 2
* Currently active second primary malignancy
18 Years
FEMALE
No
Sponsors
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Astellas Pharma Inc
INDUSTRY
AVEO Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Michael Needle
Role: STUDY_CHAIR
AVEO Pharmaceuticals, Inc.
Locations
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Birmingham, Alabama, United States
Jacksonville, Florida, United States
Miami, Florida, United States
Atlanta, Georgia, United States
Chicago, Illinois, United States
Oak Lawn, Illinois, United States
Fort Wayne, Indiana, United States
Indianapolis, Indiana, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
St Louis, Missouri, United States
New York, New York, United States
The Bronx, New York, United States
Chapel Hill, North Carolina, United States
Fargo, North Dakota, United States
Charleston, South Carolina, United States
Sioux Falls, South Dakota, United States
Memphis, Tennessee, United States
Dallas, Texas, United States
Galveston, Texas, United States
Port Macquarie, New South Wales, Australia
Woodville South, South Australia, Australia
Bentleigh, Victoria, Australia
Newcastle, , Australia
South Brisbane, , Australia
St Leonards, , Australia
Calgary, Alberta, Canada
Edmonton, Alberta, Canada
Vancouver, British Columbia, Canada
Toronto, Ontario, Canada
Saint John, , Canada
Berlin, , Germany
Cologne, , Germany
Hanau, , Germany
Leipzig, , Germany
Münster, , Germany
Tübingen, , Germany
Avellino, , Italy
Milan, , Italy
Roma, , Italy
Torino, , Italy
Viterbo, , Italy
Seoul, , South Korea
Barcelona, , Spain
Madrid, , Spain
Málaga, , Spain
Seville, , Spain
Kaohsiung City, , Taiwan
Taipei, , Taiwan
Nassau, , The Bahamas
Dnipropetrovsk, , Ukraine
Donetsk, , Ukraine
Uzhhorod, , Ukraine
Vinnytsia, , Ukraine
Countries
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Related Links
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Aveo Pharmaceuticals, Inc. official web page
Other Identifiers
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2012-003507-35
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
AV-951-12-204
Identifier Type: -
Identifier Source: org_study_id