A Study of ARRY-520 in Patients With Advanced Myeloid Leukemia
Status:
Completed
Trial end date:
2010-06-21
Target enrollment:
Participant gender:
Summary
This is a 2-phase study during which patients with select myeloid leukemias or advanced
myelodysplastic syndrome (MDS), who have failed, refused or are not eligible for standard
treatment, will receive investigational study drug ARRY-520.
The study has 3 parts. The first phase of the study, Phase 1, has 2 parts. In the first part
of Phase 1, patients with select myeloid leukemias or advanced MDS will receive increasing
doses of study drug on different schedules in order to achieve the highest dose possible that
will not cause unacceptable side effects. Approximately 30 patients (per schedule) from the
US will be enrolled in Part 1 (Completed). In the second part of Phase 1, patients with
advanced MDS will receive the best dose of study drug and schedule determined from the first
part of the study. Approximately 10 patients from the US will be enrolled in Part 2
(Completed).
In the third part of the study, Phase 2, patients with acute myeloid leukemia (AML) or
advanced MDS will receive the best dose of study drug and schedule determined from the first
part of the study and will be followed to see what side effects the study drug causes and to
see what effectiveness it has, if any, in treating the cancer. Approximately 40 patients from
the US will be enrolled in Part 3 (Withdrawn).