Safety Study of BEZ235 With Everolimus in Subjects With Advanced Solid Tumors
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||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|
- Dose limiting toxicity [ Time Frame: 28 days ]
|Study Start Date:||January 2012|
|Study Completion Date:||December 2014|
|Primary Completion Date:||February 2014 (Final data collection date for primary outcome measure)|
|Experimental: BEZ235 and Everolimus||
dose escalation 400mg- 1000mg per dayDrug: Everolimus
dose escalation 2.5 to 5 mg per day
Other Name: RAD001
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01508104
|United States, Ohio|
|University of Cincinnati|
|Cincinnati, Ohio, United States, 45267-0502|
|Principal Investigator:||John Morris, MD||University of Cincinnati|