Spots Global Cancer Trial Database for Tivozanib in Combination With Paclitaxel in Patients With Locally Recurrent or Metastatic Triple Negative Breast Cancer
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Trial Identification
Brief Title: Tivozanib in Combination With Paclitaxel in Patients With Locally Recurrent or Metastatic Triple Negative Breast Cancer
Official Title: A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Study Comparing Tivozanib Hydrochloride in Combination With Paclitaxel v Placebo in Combination With Paclitaxel in Locally Recurrent and/or Metastatic Triple Negative Breast Cancer
Study ID: NCT01745367
Conditions
Study Description
Brief Summary: 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.
Detailed Description: 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. 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
, 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
, Saint Louis, Missouri, United States
, Bronx, New York, United States
, New York, 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
, Nassau, , Bahamas
, Calgary, Alberta, Canada
, Edmonton, Alberta, Canada
, Vancouver, British Columbia, Canada
, Toronto, Ontario, Canada
, Saint John, , Canada
, Berlin, , Germany
, Cologne, , Germany
, Hanau am Main, , Germany
, Leipzig, , Germany
, Muenster, , Germany
, Tuebingen, , Germany
, Avellino, , Italy
, Milano, , Italy
, Roma, , Italy
, Torino, , Italy
, Viterbo, , Italy
, Seoul, , Korea, Republic of
, Barcelona, , Spain
, Madrid, , Spain
, Malaga, , Spain
, Sevilla, , Spain
, Kaohsiung, , Taiwan
, Taipei, , Taiwan
, Dnipropetrovsk, , Ukraine
, Donetsk, , Ukraine
, Uzhhorod, , Ukraine
, Vinnytsia, , Ukraine
Contact Details
Name: Michael Needle
Affiliation: AVEO Pharmaceuticals, Inc.
Role: STUDY_CHAIR
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