Overview

This trial is active, not recruiting.

Conditions breast cancer, metastatic breast cancer, mbc, her2 positive, her2, estrogen receptor positive, er, triple negative
Treatment lucitanib
Phase phase 2
Targets VEGF, HER, FGFR
Sponsor Clovis Oncology, Inc.
Start date July 2014
End date November 2016
Trial size 178 participants
Trial identifier NCT02202746, CO-3810-025

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.

United States Illinois
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
10 mg of lucitanib daily in patients with FGFR1-amplified or 11q-amplified metastatic breast cancer.
lucitanib CO-3810
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)
(Experimental)
10 mg of lucitanib daily in patients with FGFR1 non-amplified and 11q non-amplified metastatic breast cancer.
lucitanib CO-3810
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)

Primary Outcomes

Measure
Progression-Free Survival (PFS)
time frame: Screening, every 8 weeks; up to 2 years

Secondary Outcomes

Measure
Objective Response Rate (ORR)
time frame: Screening, every 8 weeks; up to 2 years
Duration of Response (DR)
time frame: Screening, every 8 weeks; up to 2 years
Disease Control Rate (DCR)
time frame: Screening, every 8 weeks; up to 2 years
Overall Survival (OS)
time frame: Continuously; up to 2 years
Patient Reported Outcomes (PRO)
time frame: Screening, every 8 weeks; up to 2 years
Safety Analyses
time frame: Continuously; up to 2 years
AUC of lucitanib in a capsule formulation vs. in a tablet formulation
time frame: Study Day -7; Study Day 1
Cmax of lucitanib in a capsule formulation vs. in a tablet formulation
time frame: Study Day -7; Study Day 1
Tmax of lucitanib in a capsule formulation vs. in a tablet formulation
time frame: Study Day -7; Study Day 1
T1/2 of lucitanib in a capsule formulation vs. in a tablet formulation
time frame: Study Day -7; Study Day 1
Vss/F of lucitanib in a capsule formulation vs. in a tablet formulation
time frame: Study Day -7; Study Day 1
Total plasma clearance of lucitanib in a capsule formulation vs. in a tablet formulation
time frame: Study Day -7; Study Day 1

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title A Phase 2, Open-label, Multicenter, Safety and Efficacy Study of Oral Lucitanib in Patients With FGF Aberrant Metastatic Breast Cancer
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, 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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Clovis Oncology, Inc..