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Bone Density Conservation Agents

Mibefradil

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Calcium Channel Blockers

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Enzyme Inhibitors

Cytochrome P-450 Enzyme Inhibitors

Patients will receive mibefradil dihydrochloride, which will be dose escalated from 150mg/day until the maximum tolerated dose (MTD) is determined, or until a dose of 350 mg/day is reached using a standard 3 + 3 design. Mibefradil dihydrochloride will be dosed orally in 4 divided doses per day for 17 consecutive days to the MTD.

This will be given concurrently with hypofractionated radiation therapy.

Mibefradil with Radiation

Ranjit S Bindra, MD PhD

This is a dose-escalation study that will assess the safety and determine the maximum tolerated dose (MTD) of mibefradil dihydrochloride, a partially selective T-type calcium channel blocker, combined with hypofractionated radiation therapy (RT) in subjects with recurrent glioblastoma multiforme (GBM).

Patients will receive mibefradil dihydrochloride, which will be dose escalated from 150mg/day until the maximum tolerated dose (MTD) is determined, or until a dose of 350 mg/day is reached using a standard 3 + 3 design. Mibefradil dihydrochloride will be dosed orally in 4 divided doses per day for 17 consecutive days to the MTD. The MTD will be determined according to dose-limiting toxicities (DLTs) graded using the Common Terminology Criteria for Adverse Events version 4.0. Radiation therapy (RT) consists of 5 fractions of 600 centigray (cGy) each, delivered over 2 consecutive weeks for a total dose of 3,000 cGy, using stereotactic, intensity-modulated radiation therapy (IMRT).

The primary endpoint of the study is to determine the MTD of mibefradil dihydrochloride when given with concurrent hypofractionated RT. Secondary and tertiary endpoints include evaluating the efficacy of mibefradil dihydrochloride and RT in terms of progression-free survival (PFS) and overall survival (OS), and to perform translational research on resected tumor tissue.

TAU-2014-1: Mibefradil and Hypofractionated Re-Irradiation Therapy in Recurrent GBM

TAU-2014-1: Phase I Trial of Mibefradil Dihydrochloride With Hypofractionated Re-Irradiation Therapy in Treating Patients With Recurrent Glioblastoma Multiforme (GBM)

Yale University

Jazz Pharmaceuticals

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
TAU-2014-1: Mibefradil and Hypofractionated Re-Irradiation Therapy in Recurrent GBM	NCT02202993	Glioblastoma Mu...	Mibefradil with...	18 Years - 80 Years	Jazz Pharmaceuticals
TAU-2014-1: Mibefradil and Hypofractionated Re-Irradiation Therapy in Recurrent GBM	NCT02202993	Glioblastoma Mu...	Mibefradil with...	18 Years - 80 Years	Jazz Pharmaceuticals

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