A Study to Assess the Safety and Efficacy of the VEGFR-FGFR-PDGFR Inhibitor, Lucitanib, Given to Patients With Metastatic Breast Cancer
Status: | Completed |
---|---|
Conditions: | Breast Cancer, Cancer, Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 9/15/2018 |
Start Date: | July 2014 |
End Date: | December 2016 |
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.
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, 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.
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.
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
We found this trial at
33
sites
Click here to add this to my saved trials
University of Southern California The University of Southern California is one of the world’s leading...
Click here to add this to my saved trials
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
Click here to add this to my saved trials
University of California at Los Angeles The University of California, Los Angeles (UCLA) is an...
Click here to add this to my saved trials
Vanderbilt-Ingram Cancer Center The Vanderbilt-Ingram Cancer Center, located in Nashville, Tenn., brings together the clinical...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
University of Chicago Medical Center The University of Chicago Medicine has been at the forefront...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
9280 W. Sunset Road
Suite 100
Las Vegas, Nevada 89148
Las Vegas, Nevada 89148
702.952.1251
Comprehensive Cancer Centers of Nevada Comprehensive Cancer Centers of Nevada (CCCN) is the award-winning multidisciplinary...
Click here to add this to my saved trials
Sarah Cannon Cancer Center People who live with cancer
Click here to add this to my saved trials
Yale University Yale's roots can be traced back to the 1640s, when colonial clergymen led...
Click here to add this to my saved trials
Click here to add this to my saved trials
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
Click here to add this to my saved trials
Virginia Oncology Associates Virginia Oncology Associates is an oncology and hematology practice of physicians, specializing...
Click here to add this to my saved trials
University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials