Safety Study of BEZ235 With Everolimus in Subjects With Advanced Solid Tumors
|ClinicalTrials.gov Identifier: NCT01508104|
Recruitment Status : Terminated (funding)
First Posted : January 11, 2012
Last Update Posted : August 23, 2017
|Condition or disease||Intervention/treatment||Phase|
|Cancer||Drug: BEZ235 Drug: Everolimus||Phase 1|
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).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||19 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||January 2012|
|Actual Primary Completion Date :||February 2014|
|Actual Study Completion Date :||December 2014|
|Experimental: BEZ235 and Everolimus||
dose escalation 400mg- 1000mg per dayDrug: Everolimus
dose escalation 2.5 to 5 mg per day
Other Name: RAD001
- Dose limiting toxicity [ Time Frame: 28 days ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01508104
|United States, Ohio|
|University of Cincinnati|
|Cincinnati, Ohio, United States, 45267-0502|
|Principal Investigator:||John Morris, MD||University of Cincinnati|