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Spots Global Cancer Trial Database for A Study to Assess the Safety and Efficacy of the VEGFR-FGFR-PDGFR Inhibitor, Lucitanib, Given to Patients With Metastatic Breast Cancer

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Trial Identification

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

Interventions

Lucitanib

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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