A Study of ARRY-520 in Patients With Advanced Myeloid Leukemia
Completed · Phase 1/Phase 2
Conditions studied: Advanced MDS, Acute Myeloid Leukemia
In brief
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 Approximately 40 patients from the US will be enrolled in Part 3 (Withdrawn).
Key facts
- Study ID
- NCT00637052
- Run by
- Pfizer
- People needed
- 36
- Starts
- 2008-03-18
- Expected to finish
- 2010-06-21
- Last updated by the study team
- 2021-02-08
Who can join
Age: 17 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Emory University School of Medicine, Winship Cancer Center — Atlanta, Georgia, United States
- University of Texas, M.D. Anderson Cancer Center — Houston, Texas, United States
Full record on ClinicalTrials.gov
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