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

Completed · Phase 1

Conditions studied: Myelodysplastic Syndromes

In brief

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).

Key facts

Study ID
NCT00916227
Run by
Array Biopharma, now a wholly owned subsidiary of Pfizer
People needed
45
Starts
2009-06-01
Last updated by the study team
2020-09-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

Where it is running

Full record on ClinicalTrials.gov

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