Lymphoma Clinical Trial
Official title:
A Phase 1b Study to Evaluate the Safety and Tolerability of AMG 655 in Combination With Bortezomib or Vorinostat in Subjects With Relapsed or Refractory Lymphoma
This is a multi-center, phase 1b study of AMG 655 in combination with bortezomib or
vorinostat in subjects with relapsed or refractory low grade lymphoma, mantle cell lymphoma,
diffuse large cell lymphoma, and Hodgkin's disease.
Part 1 is an open-label, dose-escalation phase (3+3 design) to determine the safety,
tolerability and maximum tolerated dose of AMG 655 in combination with bortezomib or
vorinostat. Subjects will be enrolled into one of two arms based on investigator selection
(either the bortezomib + AMG 655 arm or vorinostat + AMG 655 arm).
Part 2 of the study is a dose expansion phase that will commence after dose selection of AMG
655 in combination with bortezomib in Part 1. In Part 2, subjects (n = 20) with mantle cell
lymphoma will be given AMG 655 in combination with bortezomib. The dose of AMG 655 used in
combination with bortezomib will be based on safety and pharmacokinetic information obtained
from Part 1 as well as from ongoing AMG 655 trials.
n/a
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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