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

Phase 1

Completed

• Conditions: Acute Myeloid Leukemia; Advanced MDS
• Interventions: Drug: ARRY-520, KSP(Eg5) inhibitor; intravenous

• Registration Number: NCT00637052
• Lead Sponsor: Pfizer

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 Approximately 40 patients from the US will be enrolled in Part 3 (Withdrawn).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-02-22
• Study First Submitted QC: 2008-03-14
• Study First Posted: 2008-03-17
• Study Start: 2008-03-18
• Primary Completion: 2010-06-21
• Study Completion: 2010-06-21
• Disposition First Submitted: 2012-01-13
• Disposition First Submitted QC: 2012-01-13
• Disposition First Posted: 2012-01-19
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-04
• Last Update Posted: 2021-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ARRY-520	ARRY-520, KSP(Eg5) inhibitor; intravenous	-

Primary Outcome Measures

Name	Time	Method
Characterize the safety profile of the study drug in terms of adverse events, dose limiting toxicity, clinical laboratory tests, weight, electrocardiograms and physical examinations.	Part 1 and Part 2
Characterize the pharmacokinetics (PK) of the study drug.	Part 1
Establish the maximum tolerated dose (MTD) of the study drug.	Part 1
Assess the efficacy of the study drug in terms of incidence of complete remission (CR) and hematologic improvement (CRp).	Part 3

Secondary Outcome Measures

Name	Time	Method
Assess the efficacy of the study drug in terms of incidence of CR and CRp.	Part 1 and Part 2
Characterize the safety profile of the study drug in terms of adverse events, dose limiting toxicity, clinical laboratory tests, weight, electrocardiograms and physical examinations.	Part 3

Trial Locations

Locations (2)

Emory University School of Medicine, Winship Cancer Center; 🇺🇸 Atlanta, Georgia, United States

University of Texas, M.D. Anderson Cancer Center; 🇺🇸 Houston, Texas, United States