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Discover 16,915 clinical trials near Tennessee. Find research studies in your area.
Showing 11581-11600 of 16,915 trials
NCT01458067
The study consists of a pre-screening period to determine if the subject's tumor has PTEN deficiencies. Subjects then continue into the screening phase for Part 1, 2, or 3, as appropriate. In Part 1, subjects will then receive a single dose of 25 mg. After analysis of 24 hour pharmacokinetic (PK) samples, subjects may receive continuous dosing or receive a single modified dose. In Part 2, subjects will be enrolled and dose escalation will occur in a 3+3 design. Subjects will receive a single dose on Day 1, and then begin continuous daily dosing after collection of a 72-hour PK sample. Additional subjects may be enrolled at lower dose levels for assessment of pharmacodynamic response. In Part 3, up to two tumor-specific expansion cohorts will be enrolled and receive the MTD or BED as defined in Part 2. A minimum of 12 and a maximum of 20 evaluable subjects will be enrolled in each cohort. Interim monitoring for futility will be incorporated after response data from 12 subjects are available. In addition, up to 20 evaluable subjects will be enrolled into Part 3 -Signal-finding Expansion Cohort at the MTD or BED as defined in Part 2. All subjects in all parts/cohorts will receive daily dosing until withdrawal or unacceptable toxicity. All subjects in all parts/cohorts will receive daily dosing until withdrawal or unacceptable toxicity.
NCT01954394
Primary Objective: To assess the long-term safety of alirocumab (SAR236553/REGN727) when added to lipid-lowering therapy in participants with heterozygous familial hypercholesterolemia (heFH) who had completed EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500), EFC12732 (NCT01617655) and LTS11717 (NCT01507831). Secondary Objectives: * To evaluate the long-term efficacy of alirocumab on lipid parameters. * To evaluate the long-term immunogenicity of alirocumab.