NCT01508104

Safety Study of BEZ235 With Everolimus in Subjects With Advanced Solid Tumors

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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: University of Cincinnati · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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).

Conditions

• Cancer

Interventions

Type	Name	Description
DRUG	BEZ235	dose escalation 400mg- 1000mg per day
DRUG	Everolimus	dose escalation 2.5 to 5 mg per day

Timeline

• Start date: 2012-01-01
• Primary completion: 2014-02-01
• Completion: 2014-12-01
• First posted: 2012-01-11
• Last updated: 2017-08-23

Locations

1 site across 1 country: United States