NCT00637052

A Study of ARRY-520 in Patients With Advanced Myeloid Leukemia

A Phase 1/2 Study of ARRY-520 in Patients With Advanced Myeloid Leukemia

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 17 Years
• Healthy volunteers: Not accepted

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 Approximately 40 patients from the US will be enrolled in Part 3 (Withdrawn).

Conditions

• Advanced MDS
• Acute Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	ARRY-520, KSP(Eg5) inhibitor; intravenous	Part 1: multiple dose, escalating; Part 2: multiple dose, single schedule; Part 3: multiple dose, single schedule.

Timeline

• Start date: 2008-03-18
• Primary completion: 2010-06-21
• Completion: 2010-06-21
• First posted: 2008-03-17
• Last updated: 2021-02-08

Locations

2 sites across 1 country: United States