An International, Randomized, Double-Blind, Controlled Study of Rindopepimut/GM-CSF With Adjuvant Temozolomide in Patients With Newly Diagnosed, Surgically Resected, EGFRvIII-positive Glioblastoma
The purpose of this research study is to find out whether adding an experimental vaccine
called rindopepimut (also known as CDX-110) to the commonly used chemotherapy drug
temozolomide can help improve the life expectancy of patients with newly diagnosed, resected
EGFRvIII positive glioblastoma.
The duration of participation in this study may be up to 5 years. After you are screened and
enrolled in the study, you will be administered temozolomide and either rindopepimut/GM-CSF
or KLH until either disease progression or intolerance to the medications. If your tumor
progresses while on this study, your doctor may treat you with other therapies that are not
part of the study.
A Phase 2, Open-label, Multicenter, Safety and Efficacy Study of Oral Lucitanib in Patients With FGF 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.
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