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



Status:Completed
Conditions:Breast Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:9/15/2018
Start Date:July 2014
End Date:December 2016

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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, is 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.

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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
We found this trial at
33
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Redondo Beach, California 90277
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Los Angeles, California 90033
213) 740-2311
University of Southern California The University of Southern California is one of the world’s leading...
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Los Angeles, CA
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8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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Los Angeles, California 90095
310-825-4321
University of California at Los Angeles The University of California, Los Angeles (UCLA) is an...
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2220 Pierce Ave
Nashville, Tennessee 37232
615-936-8422
Vanderbilt-Ingram Cancer Center The Vanderbilt-Ingram Cancer Center, located in Nashville, Tenn., brings together the clinical...
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Nashville, TN
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Austin, Texas 78731
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Bakersfield, California 93309
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Baltimore, MD
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Boston, MA
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Bronx, New York 10469
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Bronx, NY
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Chicago, IL
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5841 S Maryland Ave
Chicago, Illinois 60637
(773) 702-1000
University of Chicago Medical Center The University of Chicago Medicine has been at the forefront...
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Cleveland, OH
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Dallas, TX
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Deerfield Beach, Florida 33442
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Fullerton, California 92835
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Hollywood, Florida 33021
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Houston, Texas 77024
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Indianapolis, Indiana 46202
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La Jolla, California 92093
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Lafayette, Indiana 47905
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9280 W. Sunset Road Suite 100
Las Vegas, Nevada 89148
702.952.1251
Comprehensive Cancer Centers of Nevada Comprehensive Cancer Centers of Nevada (CCCN) is the award-winning multidisciplinary...
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230 25th Ave N
Nashville, Tennessee 37203
(615) 329-7274
Sarah Cannon Cancer Center People who live with cancer
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New Haven, Connecticut 6520
(203) 432-4771
Yale University Yale's roots can be traced back to the 1640s, when colonial clergymen led...
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New York, New York 10065
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1275 York Ave
New York, New York 10021
(212) 639-2000
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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5900 Lake Wright Dr
Norfolk, Virginia 23502
(757) 466-8683
Virginia Oncology Associates Virginia Oncology Associates is an oncology and hematology practice of physicians, specializing...
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Norfolk, VA
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200 Lothrop St
Pittsburgh, Pennsylvania 15213
University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
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San Francisco, California 94143
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Santa Maria, California 93454
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Sedona, Arizona 86336
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Voorhees, New Jersey 08043
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