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

Last updated: June 20, 2020
Sponsor: Clovis Oncology, Inc.
Overall Status: Terminated

Phase

2

Condition

Breast Cancer

Metastatic Cancer

Cancer

Treatment

N/A

Clinical Study ID

NCT02202746
CO-3810-025
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Histologically or cytologically confirmed metastatic breast cancer relapsed orrefractory 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 11qamplification status

  • Demonstrated progression of disease by radiological or clinical assessment (Measurabledisease according to RECIST Version 1.1 is NOT required for enrollment)

  • Estimated life expectancy >6 months

Exclusion

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

Study Design

Total Participants: 178
Study Start date:
September 09, 2014
Estimated Completion Date:
January 18, 2017

Study 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.

Connect with a study center

  • Arizona Oncology Associates

    Sedona, Arizona 86336
    United States

    Site Not Available

  • Comprehensive Blood and Cancer Center

    Bakersfield, California 93309
    United States

    Site Not Available

  • Saint Jude Heritage Medical Center

    Fullerton, California 92835
    United States

    Site Not Available

  • Moores UCSD Cancer Center

    La Jolla, California 92093
    United States

    Site Not Available

  • Cedars-Sinai Medical Center

    Los Angeles, California 90048
    United States

    Site Not Available

  • University of California, Los Angeles

    Los Angeles, California 90095
    United States

    Site Not Available

  • University of Southern California

    Los Angeles, California 90033
    United States

    Site Not Available

  • Cancer Care Associates Medical Group, Inc.

    Redondo Beach, California 90277
    United States

    Site Not Available

  • University of California San Francisco

    San Francisco, California 94115
    United States

    Site Not Available

  • Central Coast Medical Oncology Group

    Santa Maria, California 93454
    United States

    Site Not Available

  • Yale University

    New Haven, Connecticut 06519
    United States

    Site Not Available

  • University of Miami

    Deerfield Beach, Florida 33442
    United States

    Site Not Available

  • Memorial West Cancer Center

    Hollywood, Florida 33021
    United States

    Site Not Available

  • Northwestern University, Robert H. Lurie Comprehensive Cancer Center

    Chicago, Illinois 60611
    United States

    Site Not Available

  • University of Chicago Medical Center

    Chicago, Illinois 60637
    United States

    Site Not Available

  • Indiana University Simon Cancer Center

    Indianapolis, Indiana 46202
    United States

    Site Not Available

  • Horizon Oncology Center

    Lafayette, Indiana 47905
    United States

    Site Not Available

  • The Sidney Kimmel Comprehensive Cancer Center at John Hopkins

    Baltimore, Maryland 21231
    United States

    Site Not Available

  • Dana Farber Cancer Institute

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada 89169
    United States

    Site Not Available

  • Cooper University Hospital

    Voorhees, New Jersey 08043
    United States

    Site Not Available

  • Sciode Medical Associates, PLLC

    Bronx, New York 10469
    United States

    Site Not Available

  • Memorial Sloan-Kettering Cancer Center

    New York, New York 10065
    United States

    Site Not Available

  • Weill Cornell Breast Center

    New York, New York 10065
    United States

    Site Not Available

  • University Hospitals Case Medical Center

    Cleveland, Ohio 44106
    United States

    Site Not Available

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania 15213
    United States

    Site Not Available

  • Sarah Cannon Cancer Center

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • Vanderbilt Ingram Cancer Center

    Nashville, Tennessee 37232
    United States

    Site Not Available

  • Texas Oncology - Austin Central

    Austin, Texas 78731
    United States

    Site Not Available

  • Texas Oncology - Baylor Charles A. Sammons Cancer Center

    Dallas, Texas 75246
    United States

    Site Not Available

  • The Center for Cancer and Blood Disorders

    Fort Worth, Texas 76104
    United States

    Site Not Available

  • US Oncology

    Houston, Texas 77024
    United States

    Site Not Available

  • Virginia Oncology Associates

    Norfolk, Virginia 23502
    United States

    Site Not Available

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