NCT01343498

Study of PI3 Kinase/mTOR Inhibitor BEZ235 Twice Daily for Advanced Solid Tumors

A Phase I PK/PD Study of the PI3 Kinase/mTOR Inhibitor BEZ235 Given Twice Daily for the Treatment of Patients With Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: SCRI Development Innovations, LLC · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a dose escalation trial to evaluate twice daily dosing of the sachet formulation of BEZ235. This trial will find the maximum tolerated dose (MTD) of the sachet formulation given twice daily, as well as evaluate pharmacokinetics (PK) and pharmacodynamics (PD) of the twice daily dosing. Patients will initially be given once daily dosing to determine the PK and PD of the single daily dose. On Day 9, they will begin twice daily dosing, with half of the single daily dose divided twice daily, and PK and PD of the twice daily dose will be determined.

Conditions

• Malignant Solid Tumour

Interventions

Type	Name	Description
DRUG	BEZ235	BEZ235 will be given on a dose-escalation design, beginning at 200 mg BID (SDS sachet) in 3 patients and progressing to 400 mg, 600 mg, and 800 mg respectively based on tolerability.

Timeline

• Start date: 2011-04-01
• Primary completion: 2014-01-01
• Completion: 2014-01-01
• First posted: 2011-04-28
• Last updated: 2015-05-01

Locations

2 sites across 1 country: United States