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Brief Title: A Study to Assess the Safety and Efficacy of the VEGFR-FGFR-PDGFR Inhibitor, Lucitanib, Given to Patients With Metastatic Breast Cancer
Official Title: A Phase 2, Open-label, Multicenter, Safety and Efficacy Study of Oral Lucitanib in Patients With FGF Aberrant Metastatic Breast Cancer
Study ID: NCT02202746
Brief Summary: The purpose of this study is to determine whether lucitanib is safe and effective in the treatment of patients with FGF aberrant metastatic breast cancer, as well as in the treatment of patients with biomarker negative (FGF non-aberrant) metastatic breast cancer.
Detailed Description: Lucitanib is a selective, orally available tyrosine kinase inhibitor targeting FGFR1-3, VEGFR1-3, and PDGFRα and β, with activity in relevant cell lines and animal models. The first in human trial of lucitanib demonstrated that daily dosing with lucitanib can provide durable clinical responses in patients with FGFR1- or 11q (FGF3, FGF4, Cyclin D1, or FGF19)-amplified breast cancer. RECIST partial responses (PRs) were also observed in patients not known to have FGF abnormalities. Based on these results, this study is designed to explore the safety and anti-tumor activity of daily lucitanib in breast cancer patients with and without alterations of the FGF pathway.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Arizona Oncology Associates, Sedona, Arizona, United States
Comprehensive Blood and Cancer Center, Bakersfield, California, United States
Saint Jude Heritage Medical Center, Fullerton, California, United States
Moores UCSD Cancer Center, La Jolla, California, United States
University of Southern California, Los Angeles, California, United States
Cedars-Sinai Medical Center, Los Angeles, California, United States
University of California, Los Angeles, Los Angeles, California, United States
Cancer Care Associates Medical Group, Inc., Redondo Beach, California, United States
University of California San Francisco, San Francisco, California, United States
Central Coast Medical Oncology Group, Santa Maria, California, United States
Yale University, New Haven, Connecticut, United States
University of Miami, Deerfield Beach, Florida, United States
Memorial West Cancer Center, Hollywood, Florida, United States
Northwestern University, Robert H. Lurie Comprehensive Cancer Center, Chicago, Illinois, United States
University of Chicago Medical Center, Chicago, Illinois, United States
Indiana University Simon Cancer Center, Indianapolis, Indiana, United States
Horizon Oncology Center, Lafayette, Indiana, United States
The Sidney Kimmel Comprehensive Cancer Center at John Hopkins, Baltimore, Maryland, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
Comprehensive Cancer Centers of Nevada, Las Vegas, Nevada, United States
Cooper University Hospital, Voorhees, New Jersey, United States
Sciode Medical Associates, PLLC, Bronx, New York, United States
Memorial Sloan-Kettering Cancer Center, New York, New York, United States
Weill Cornell Breast Center, New York, New York, United States
University Hospitals Case Medical Center, Cleveland, Ohio, United States
University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, United States
Sarah Cannon Cancer Center, Nashville, Tennessee, United States
Vanderbilt Ingram Cancer Center, Nashville, Tennessee, United States
Texas Oncology - Austin Central, Austin, Texas, United States
Texas Oncology - Baylor Charles A. Sammons Cancer Center, Dallas, Texas, United States
The Center for Cancer and Blood Disorders, Fort Worth, Texas, United States
US Oncology, Houston, Texas, United States
Virginia Oncology Associates, Norfolk, Virginia, United States