A Study to Assess the Safety and Efficacy of the VEGFR-FGFR-PDGFR Inhibitor, Lucitanib, Given to Patients With Metastatic Breast Cancer
NCT ID: NCT02202746
Last Updated: 2020-06-23
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
178 participants
INTERVENTIONAL
2014-09-09
2017-01-18
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cohort A: Lucitanib (CO-3810) 10 mg daily
10 mg of lucitanib daily in patients with FGFR1-amplified or 11q-amplified metastatic breast cancer.
Lucitanib
Lucitanib is a potent, orally available selective inhibitor of the tyrosine kinase activity of fibroblast growth factor receptors (FGFR1-3), vascular endothelial growth factor receptors (VEGFR1-3), and platelet-derived growth factor receptors alpha and beta (PDGFR alpha and beta)
Cohort B: Lucitanib (CO-3810) 15 mg daily
15 mg of lucitanib daily in patients with FGFR1-amplified and 11q-amplified metastatic breast cancer.
Lucitanib
Lucitanib is a potent, orally available selective inhibitor of the tyrosine kinase activity of fibroblast growth factor receptors (FGFR1-3), vascular endothelial growth factor receptors (VEGFR1-3), and platelet-derived growth factor receptors alpha and beta (PDGFR alpha and beta)
Cohort C: Lucitanib (CO-3810) 10 mg daily
10 mg of lucitanib daily in patients with FGFR1 non-amplified and 11q non-amplified metastatic breast cancer.
Lucitanib
Lucitanib is a potent, orally available selective inhibitor of the tyrosine kinase activity of fibroblast growth factor receptors (FGFR1-3), vascular endothelial growth factor receptors (VEGFR1-3), and platelet-derived growth factor receptors alpha and beta (PDGFR alpha and beta)
Interventions
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Lucitanib
Lucitanib is a potent, orally available selective inhibitor of the tyrosine kinase activity of fibroblast growth factor receptors (FGFR1-3), vascular endothelial growth factor receptors (VEGFR1-3), and platelet-derived growth factor receptors alpha and beta (PDGFR alpha and beta)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Clovis Oncology, Inc.
INDUSTRY
Responsible Party
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Locations
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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
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
Countries
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References
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Liao M, Zhou J, Wride K, Lepley D, Cameron T, Sale M, Xiao J. Population Pharmacokinetic Modeling of Lucitanib in Patients with Advanced Cancer. Eur J Drug Metab Pharmacokinet. 2022 Sep;47(5):711-723. doi: 10.1007/s13318-022-00773-w. Epub 2022 Jul 18.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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CO-3810-025
Identifier Type: -
Identifier Source: org_study_id
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