Status:
TERMINATED
A Study to Assess the Safety and Efficacy of the VEGFR-FGFR-PDGFR Inhibitor, Lucitanib, Given to Patients With Metastatic Breast Cancer
Lead Sponsor:
Clovis Oncology, Inc.
Conditions:
Breast Cancer
Metastatic Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 ...
Detailed 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 9 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 18 2017
Estimated Enrollment :
178 Patients enrolled
Trial Details
Trial ID
NCT02202746
Start Date
September 9 2014
End Date
January 18 2017
Last Update
June 23 2020
Active Locations (33)
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1
Arizona Oncology Associates
Sedona, Arizona, United States, 86336
2
Comprehensive Blood and Cancer Center
Bakersfield, California, United States, 93309
3
Saint Jude Heritage Medical Center
Fullerton, California, United States, 92835
4
Moores UCSD Cancer Center
La Jolla, California, United States, 92093