Trial intelligence / Profile preview

Lucitanib in FGF Aberrant Metastatic Breast Cancer

NCT02202746Phase 2

Key facts

Status: Terminated
Start: Sep 2014
Primary completion: Jan 2017
Countries: 1
Sponsor: Clovis Oncology
Modality: Small Molecules

Drugs: lucitanib
Conditions: breast cancer

Overview

Phase 2, randomised, open-label trial of lucitanib in breast cancer (3 arms), sponsored by Clovis Oncology. Primary endpoint: Progression Free Survival up to 29 months. Started Sep 2014; status: terminated.

Design

3 arms

Study design: RandomizedOpen-label

Lucitanib 10 mg (Amplified)
10 mg daily in FGFR1/11q amplified patients
Lucitanib 15 mg (Amplified)
15 mg daily in FGFR1/11q amplified patients
Lucitanib 10 mg (Non-amplified)
10 mg daily in FGFR1/11q non-amplified patients

Who it enrols

Patients with histologically confirmed metastatic breast cancer relapsed or refractory to standard treatment, with available tumor tissue for FGFR1/11q testing, and life expectancy >6 months. Excludes patients with active CNS metastases or uncontrolled hypertension.

Endpoints

Primary

Progression Free Survivalup to 29 months

Secondary

Objective Response Rateup to 29 months
Duration of Responseup to 29 months
Disease Control Rateup to 29 months
Maximum Plasma Concentration8 days
Time to Maximum Plasma Concentration8 days
Area Under the Curve to Last Measurable Concentration8 days
Area Under the Curve to Infinity8 days
Overall Survivalup to 29 months

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