90
Participants
Start Date
December 31, 2011
Primary Completion Date
October 31, 2015
Study Completion Date
October 31, 2015
GSK2110183
The oral, once daily dose of GSK2110183 will be dependent on the cohort to which a subject is assigned. Subjects enrolled in Cohort 1 will receive 75 mg GSK2110183 once daily. Dose escalation in Schedule A and Schedule B will follow 25 mg increments in a 3+3 dose escalation procedure up to a maximum of 150mg daily or until MTD is reached, whichever comes first, for each schedule. GSK2110183 will continue at daily dosing until treatment discontinuation criteria is met.
Bortezomib
Bortezomib (1.0 mg/m2) will be administered on days 1, 4, 8, and 11 of each 21-day cycle for cohort 1 for up to 8 cycles. Bortezomib (1.3 mg/m2) will be administered on days 1, 4, 8, and 11 of each 21-day cycle for up to 8 cycles. Bortezomib (1.5 mg/m2) will be administered on days 1, 8, and 15 of each 21-day cycle for up to 8 cycles.
Dexamethasone
Dexamethasone will be given orally at a fixed dose of 20 mg only on days of bortezomib dosing in both Schedule A and Schedule B.
Novartis Investigative Site, Taipei
Novartis Investigative Site, Melbourne
Novartis Investigative Site, New York
Novartis Investigative Site, Atlanta
Novartis Investigative Site, Columbus
Novartis Investigative Site, Madison
Novartis Investigative Site, Chicago
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Novartis Investigative Site, Duarte
Novartis Investigative Site, Chapel Hill
Novartis Investigative Site, Vancouver
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Lead Sponsor
Novartis
INDUSTRY