A Phase II, Open-Label, Clinical Study to Assess the Safety and Activity of SRT501 Alone or in Combination With Bortezomib in Patients With Multiple Myeloma
This is an, open-label, phase II study of SRT501, alone or in combination with bortezomib,
in subjects with measurable Multiple Myeloma. Sixty-one (61) evaluable subjects, who
fulfill the inclusion/exclusion criteria, will be enrolled in this study. Pharmacokinetic
(PK) samples will be collected from a subset of 15 subjects to determine SRT501 plasma
concentrations in this patient population. Subjects will sign the informed consent form
prior to any study related procedures. If eligible, subjects will receive 5.0 g of SRT501
to be administered for 20 consecutive days in a 21 day cycle for a maximum of 12 cycles.
SRT501 will be administered as an oral suspension product at the same time each morning
(approximately 15-30 minutes following consumption of breakfast) on all dosing days. Safety
assessments will be performed continuously throughout the cycle and these will be reviewed
for all subjects at Day 21 of each cycle prior to subjects proceeding to the next cycle.
SRT501 will not be administered on Day 21 of each cycle. Subjects will be assessed for
efficacy and response of SRT501 at the end of every 2 cycles (6 weeks) of treatment. When
necessary, a bone marrow biopsy and CT (or appropriate radiographic imaging) of the chest
and abdomen/pelvis will be performed to confirm response. After the first two cycles of
SRT501 treatment and review of the efficacy and response analysis, any subject who exhibits
stable disease or better with SRT501 monotherapy may continue on SRT501 monotherapy (5.0
g/day) for an additional two cycles. If, after the first two cycles of SRT501 monotherapy,
a subject exhibits PD, then that subject will receive bortezomib (1.3 mg/ m2 on Day 1, Day
4, Day 8, and Day 11 in a 21 day cycle) in conjunction with SRT501 (5.0 g/day). Bortezomib
will be administered prior to SRT501 administration. If after two additional cycles of
SRT501 monotherapy (4 cycles total), the subject exhibits a MR or better, they will remain
on SRT501 (5.0 g/day) treatment until they are judged to have SD or PD. At the time the
subject is judged to have SD or PD after receiving at least four cycles of SRT501 (5.0
g/day) monotherapy, then they may also receive bortezomib (1.3 mg/m2 on Day 1, Day 4, Day 8,
and Day 11 in a 21 day cycle) in conjunction with daily SRT501 dosing. If at any point
while a subject is receiving SRT501 and bortezomib the subject is assessed to have PD, then
they will be removed from the study and will be required to undergo End of Study
assessments/follow-up approximately 28 days (+/- 7 days) following the last dose of SRT501
or SRT501 and bortezomib.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Safety and tolerability of SRT501 with or without bortezomib administration.
Safety analysis will be ongoing during the study and analyzed after the study has completed.
GSK Clinical Trials
Spain: Agencia Española del Medicamento y Productos Sanitarios