A Study of ARRY-614 in Patients With Low or Intermediate-1 Risk Myelodysplastic Syndromes
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 syndromes (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 in order to achieve the highest dose of the study drug possible that will not cause unacceptable side effects. Approximately 50 patients from the US will be enrolled in Part 1 (Completed). In the second part of the study, patients will receive the best dose of study drug 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 30 patients from the US will be enrolled in Part 2 (Completed).
Key facts
- Study ID
- NCT01496495
- Run by
- Array Biopharma, now a wholly owned subsidiary of Pfizer
- People needed
- 71
- Starts
- 2012-01-01
- Expected to finish
- 2015-03-18
- 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
- Moffitt Cancer Center — Tampa, Florida, United States
- Emory University, Winship Cancer Institute — Atlanta, Georgia, United States
- Cleveland Clinic — Cleveland, Ohio, United States
- MD Anderson Cancer Center — Houston, Texas, United States
Full record on ClinicalTrials.gov
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