Multiple Myeloma Clinical Trial
Official title:
A Phase Ib Study to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Clinical Activity of the Oral AKT Inhibitor GSK2110183 Administered in Combination With Bortezomib and Dexamethasone in Subjects With Relapsed/Refractory Multiple Myeloma
Phase Ib, open-label study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and clinical activity of GSK2110183 dosed in combination with bortezomib and dexamethasone in multiple myeloma (MM) subjects who have failed at least one line of systemic treatment. Part 1 will identify the maximum tolerated dose(s) (MTD) of the combination regimen. Schedule A - GSK2110183 administered once daily with bortezomib (1.3 mg/m2) and dexamethasone (20 mg) given biweekly. Part 2 will further explore the safety, tolerability and clinical activity of the MTD(s) identified in Part 1, including a pharmacokinetic cohort.
This is a Phase Ib, open-label study to evaluate the safety, tolerability, pharmacokinetics
(PK), pharmacodynamics (PD) and clinical activity of GSK2110183 dosed in combination with
bortezomib and dexamethasone in relapsed/refractory multiple myeloma (MM) subjects who have
failed at least one line of systemic treatment. Part 1 will identify the maximum tolerated
dose(s) (MTD) of the combination regimen.
Part 1, Schedule A will assess the safety and pharmacodynamics of GSK2110183 administered
once daily with bortezomib (1.3 mg/m2) and dexamethasone (20 mg) given biweekly. It is
estimated that up to 35-45 evaluable subjects will be enrolled in Part 1. Part 2 will explore
further the safety, tolerability, pharmacokinetics, pharmacodynamics and clinical activity of
the MTD(s) identified in Part 1. A minimum of 15 and maximum of 40 subjects will enroll in
Part 2 Safety/Clinical Activity Cohort for each Schedule explored. The Part 2 PK/PD cohort
will enroll up to 18 subjects. This pharmacokinetic cohort will explore whether exposure to
GSK2110183 at the MTD is similar when GSK2110183 is administered alone or in combination with
bortezomib and dexamethasone. The same relationship will be explored for bortezomib and
dexamethasone when the two drugs are given by themselves or in combination with GSK2110183.
The identified MTD(s) and pharmacodynamic results in this study will inform the doses for
future development of the regimen of GSK2110183 dosed in combination with bortezomib and
dexamethasone in subjects with relapsed/refractory MM.
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