A Phase Ib Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of the Oral AKT Inhibitor GSK2110183 Administered in Combination with Bortezomib and Dexamethasone in Subjects with Relapsed/Refractory Multiple Myeloma
ID Number 12-0002Principal Investigator(s)
Department(s) or Division(s)
Hematology and Medical Oncology
The purpose of this study is to test what doses of GSK2110183 can be given safely in combination with bortezomib and dexamethasone. Bortezomib (also known as Velcade) is a type of medicine called a proteasome inhibitor and is approved to treat multiple myeloma and certain types of lymphoma. Dexamethasone is a steroid medication that is usually given with bortezomib as a standard practice to improve the treatment results with bortezomib.
You may qualify to take part in this research study because you have multiple myeloma. All patients in this study will receive GSK2110183 in combination with bortezomib and dexamethasone. In Part 1 of the study, increasing doses of GSK2110183 will be given with bortezomib and dexamethasone to groups of 3-6 patients at a time. Patients will receive one of two different doses/schedules of borteozmib depending on which schedule (A-twice weekly or B weekly) they are assigned. Dexamethasone (20mg) will be administered on each day Bortezomib is given. Your study doctor will tell you to which dose of GSK2110183 you are assigned. The dose and schedule of bortezomib and dexamethasone, referred to as “schedule A”, will be the same until the highest acceptable dose of GSK2110183 is identified. Once this occurs, 3-6 additional subjects may receive the highest acceptable dose of GSK2110183, along with the same dose and schedule of bortezomib , but with an increase in the dose of dexamethasone. This is to see whether or not the increased dose of dexamethasone helps GSK2110183 and bortezomib work better. A second dose and schedule of bortezomib and dexamethasone, referred to as “Schedule B” may also be explored in this part of the study. As with schedule A, two different doses of dexamethasone may be given in patients who are enrolled in schedule B of Part 1.
In Part 2 of the study, all patients will receive the same dose and schedule of GSK2110183 and bortezomib with dexamethasone. The dose of GSK2110183 in Part 2 of the study might be adjusted during this study if we have new information. We want to find out what effects, good or bad, this combination of drugs has on you and your health. We are doing this study in patients with multiple myeloma to find out:
- Does GSK2110183 in combination with bortezomib and dexamethasone have any important side effects?
- How much of the study drugs (GSK2110183, bortezomib and dexamethasone) get into the
bloodstream, and how long does the body take to get rid of them? (pharmacokinetic studies).
- Does GSK2110183 in combination with bortezomib and dexamethasone change your cancer
cells? (pharmacodynamic studies)
- Is there something special about your cancer that makes it more or less likely to respond to the
study drug combination?
Recruiting Patients: Yes