Summary

for people ages 18 years and up (full criteria)
at La Jolla, California and other locations
study started
estimated completion:

Description

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.

Official Title

A Phase 2, Open-label, Multicenter, Safety and Efficacy Study of Oral Lucitanib in Patients With FGF Aberrant Metastatic Breast Cancer

Details

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.

Keywords

Breast Cancer Metastatic Breast Cancer MBC HER2 Positive HER2 Estrogen Receptor Positive ER Triple Negative HER2+ ER+ FGFR1 11q FGF aberrant Biomarker negative FGF non-aberrant Breast Neoplasms Lucitanib

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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 CAN'T join 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

Locations

  • Moores UCSD Cancer Center
    La Jolla California 92093 United States
  • Saint Jude Heritage Medical Center
    Fullerton California 92835 United States
  • Cancer Care Associates Medical Group, Inc.
    Redondo Beach California 90277 United States
  • University of Southern California
    Los Angeles California 90033 United States
  • Cedars-Sinai Medical Center
    Los Angeles California 90048 United States
  • University of California, Los Angeles
    Los Angeles California 90095 United States
  • Comprehensive Blood and Cancer Center
    Bakersfield California 93309 United States
  • Central Coast Medical Oncology Group
    Santa Maria California 93454 United States
  • Comprehensive Cancer Centers of Nevada
    Las Vegas Nevada 89169 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Clovis Oncology, Inc.
ID
NCT02202746
Phase
Phase 2
Study Type
Interventional
Last Updated
November 2016