Phase 1b Single Arm, Open Label, Multi-Center Study of Fluphenazine HCl Monotherapy in Relapsed or Relapsed-and-Refractory Multiple Myeloma
This is a multicenter, dose-escalating, Phase 1b trial in patients with relapsed or
relapsed-and-refractory multiple myeloma. Patients will be dosed on Days 1 and 8 of each 21
day cycle.
This study will be conducted in two parts. In Part 1, the MTD determining portion of the
study, patients will be enrolled in cohorts of 3 patients at each dose level. At least 3
patients will complete 21 days at each dose level and will be evaluated for safety and
tolerability before additional patients are treated at higher doses. Doses will be
increased following a modified Fibonacci scheme.
In Part 2, twelve additional patients will be enrolled at the MTD determined in Part 1 (or
the dose for the highest dose cohort completed if the MTD has not been reached) to further
evaluate the safety, tolerability, and preliminary efficacy of this dose regimen.
Serum fluphenazine pharmacokinetic studies will be performed during the first cycle of the
therapy in all Part 1 and Part 2 consenting patients.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Tolerability of fluphenazine.
21 day treatment cycle(s)
Yes
Bruce A Silver, M.D., FACP
Study Director
United States: Food and Drug Administration
FM-CL2
NCT00821301
December 2008
October 2010
Name | Location |
---|---|
Hospital of the University of Pennsylvania | Philadelphia, Pennsylvania 19104 |
University of Pittsburgh Cancer Institute Hillman Cancer Center | Pittsburgh, Pennsylvania 15232 |
Cancer Therapy and Research Center at the UT Health Sciences Center at San Antonio | San Antonio, Texas 78229 |