NCT00916227

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Array Biopharma, now a wholly owned subsidiary of Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Myelodysplastic Syndromes

Interventions

Type	Name	Description
DRUG	ARRY-614, p38/Tie2 inhibitor; oral	Part 1: multiple dose, escalating; Part 2: multiple dose, single schedule.

Timeline

• Start date: 2009-06-01
• Primary completion: 2012-01-01
• First posted: 2009-06-09
• Last updated: 2020-09-09

Locations

3 sites across 1 country: United States