Overview

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

Status:
Terminated
Trial end date:
2017-01-18
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Clovis Oncology, Inc.
Criteria
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