drugset / Trial / NCT00916227

A Study of ARRY-614 in Patients With Low or Intermediate-1 Risk Myelodysplastic Syndrome

NCT00916227 ↗

Phase 1 Completed 45 enrolled Array BioPharma
NaSingle-groupOpen-labelTreatment

Summary

This is a Phase 1 study during which patients with low or intermediate-1 risk myelodysplastic syndrome (MDS) will receive investigational study drug ARRY-614. This study has 2 parts. In the first part, patients will receive increasing doses of study drug, given either with food or without food, in order to achieve the highest dose of the study drug possible that will not cause unacceptable side effects. Approximately 60 patients from the US will be enrolled in Part 1 (Completed). In the second part of this study, patients will receive the best dose of study drug, given either with food or without food, determined from the first part of the study and will be followed to see what side effects and effectiveness the study drug has, if any, in treating the cancer. Approximately 40 patients from the US will be enrolled in Part 2 (Completed).

Timeline

Start
2009-06
Primary completion
2012-01
Completion
—

Drugs

EvaluationDrugModalityDoseRoute
Subject pexmetinib Small molecule — Oral