A Dose Escalation, Single Arm, Phase 1b-2 Combination Study of BEZ235 With Everolimus to Determine the Safety, Pharmacodynamics and Pharmacokinetics in Subjects With Advanced Solid Malignancies
BEZ235 is an agent that was developed to slow down or halt cell growth and proliferation. It
works by inhibiting two pathways that are important for cell growth and replication, one is
called mTOR and the other is called PI3K.
Everolimus is an agent that also targets mTOR thus also slows down cell growth and spread;
in addition, it injures blood vessels that supply cancer cells with nutrition.
The rationale behind combining Everolimus with BEZ235 is to inhibit cell growth and halt
cancer spread by greater degree than either drug alone.
BEZ235 is not approved by the FDA for use in humans outside the context of a clinical trial.
Everolimus is FDA approved for the treatment of renal cell carcinoma (kidney cancer),
subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis (TS), and
Advanced Neuroendocrine Tumors of Pancreatic Origin (PNET).
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Dose limiting toxicity
Olivier Rixe, MD, PhD
University of Cincinnati
United States: Food and Drug Administration
|University of Cincinnati||Cincinnati, Ohio 45267-0502|