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

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.

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