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A Phase 2, Open-label, Multicenter, Safety and Efficacy Study of Oral Lucitanib in Patients With FGF Aberrant Metastatic Breast Cancer
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.
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.
Age
18 - No limit years
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
Start Date
September 9, 2014
Primary Completion Date
January 17, 2017
Completion Date
January 18, 2017
Last Updated
June 23, 2020
178
ACTUAL participants
Lucitanib
DRUG
Lead Sponsor
Clovis Oncology, Inc.
NCT05673200
NCT05245812
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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