Ph 1b Study to Evaluate GSK2110183 in Combination With Bortezomib and Dexamethasone in Subjects With Multiple Myeloma
Status:
Completed
Trial end date:
2015-10-01
Target enrollment:
Participant gender:
Summary
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.