Spots Global Cancer Trial Database for Study of PI3 Kinase/mTOR Inhibitor BEZ235 Twice Daily for Advanced Solid Tumors
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Trial Identification
Brief Title: Study of PI3 Kinase/mTOR Inhibitor BEZ235 Twice Daily for Advanced Solid Tumors
Official Title: 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
Study ID: NCT01343498
Conditions
Interventions
Study Description
Brief 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.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Oklahoma University, Oklahoma City, Oklahoma, United States
Tennessee Oncology, Nashville, Tennessee, United States
Contact Details
Name: Johanna C Bendell, M.D.
Affiliation: SCRI Development Innovations, LLC
Role: STUDY_CHAIR
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