Trials / Terminated
TerminatedNCT02202746
A Study to Assess the Safety and Efficacy of the VEGFR-FGFR-PDGFR Inhibitor, Lucitanib, Given to Patients With Metastatic Breast Cancer
A Phase 2, Open-label, Multicenter, Safety and Efficacy Study of Oral Lucitanib in Patients With FGF Aberrant Metastatic Breast Cancer
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 178 (actual)
- Sponsor
- Clovis Oncology, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
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 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, this 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.
Conditions
- Breast Cancer
- Metastatic Breast Cancer
- MBC
- HER2 Positive
- HER2
- Estrogen Receptor Positive
- ER
- Triple Negative
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Lucitanib | 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) |
Timeline
- Start date
- 2014-09-09
- Primary completion
- 2017-01-17
- Completion
- 2017-01-18
- First posted
- 2014-07-29
- Last updated
- 2020-06-23
- Results posted
- 2020-06-23
Locations
33 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02202746. Inclusion in this directory is not an endorsement.