Safety Study of BEZ235 With Everolimus in Subjects With Advanced Solid Tumors
The purpose of this clinical trial is to determine the effects good or bad of combining BEZ235 along with Everolimus to determine if it is a safe treatment for patients with advanced cancers of different types.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]
|Study Start Date:||January 2012|
|Estimated Study Completion Date:||June 2015|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
|Experimental: BEZ235 and Everolimus||
dose escalation 400mg- 1000mg per day
Other Name: BEZ235Drug: 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).
|Contact: UC Cancer Institute||513-584-7698|
|Contact: UC Cancer Institute|
|United States, Ohio|
|University of Cincinnati||Recruiting|
|Cincinnati, Ohio, United States, 45267-0502|
|Contact: UC Cancer Institute 513-584-7698|
|Principal Investigator: Olivier Rixe, MD, PhD|
|Principal Investigator:||Olivier Rixe, MD, PhD||University of Cincinnati|