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

Stopped early · Phase 2

Conditions studied: Breast Cancer, Metastatic Breast Cancer, MBC, HER2 Positive, HER2, Estrogen Receptor Positive, ER, Triple Negative

In brief

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.

Key facts

Study ID

NCT02202746

Run by

Clovis Oncology, Inc.

People needed

178

Starts

2014-09-09

Expected to finish

2017-01-18

Last updated by the study team

2020-06-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically or cytologically confirmed metastatic breast cancer relapsed or refractory to approved standard available treatment
• Prior treatment with standard first line therapy in the metastatic setting
• Availability of tumor tissue sufficient for confirmatory testing of FGFR1 and 11q amplification status
• Demonstrated progression of disease by radiological or clinical assessment (Measurable disease according to RECIST Version 1.1 is NOT required for enrollment)
• Estimated life expectancy >6 months

You may not qualify if…

• Current or recent treatment with biologic anticancer therapies
• Ongoing AEs from prior anticancer therapies
• Active central nervous system (CNS) metastases
• Clinically significant or uncontrolled hypertension or cardiac disease
• Females who are pregnant or breastfeeding

Where it is running

• 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 Township, New Jersey, United States
• Memorial Sloan-Kettering Cancer Center — New York, New York, United States
• Weill Cornell Breast Center — New York, New York, United States
• Sciode Medical Associates, PLLC — The Bronx, New York, United States
• University Hospitals Case Medical Center — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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