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

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00637052
• Collaborator: (none)
• Enrollment: 36
• Locations: 2
• Arm: 1
• Actual Duration (Months): 27.1
• Patients Per Site: 18
• Patients Per Site Per Month: 0.7

Study Details

Study Description

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 Approximately 40 patients from the US will be enrolled in Part 3 (Withdrawn).

Condition or Disease	Intervention/Treatment	Phase
Advanced MDS; Acute Myeloid Leukemia	Drug: ARRY-520, KSP(Eg5) inhibitor; intravenous	Phase 1/Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 36 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Primary Purpose: Treatment
• Official Title: A Phase 1/2 Study of ARRY-520 in Patients With Advanced Myeloid Leukemia
• Actual Study Start Date: Mar 18, 2008
• Actual Primary Completion Date: Jun 21, 2010
• Actual Study Completion Date: Jun 21, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ARRY-520	Drug: ARRY-520, KSP(Eg5) inhibitor; intravenous; Part 1: multiple dose, escalating; Part 2: multiple dose, single schedule; Part 3: multiple dose, single schedule.

Outcome Measures

Primary Outcome Measures

1. Establish the maximum tolerated dose (MTD) of the study drug. [Part 1]

2. Characterize the pharmacokinetics (PK) of the study drug. [Part 1]

3. 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]

4. Assess the efficacy of the study drug in terms of incidence of complete remission (CR) and hematologic improvement (CRp). [Part 3]

Secondary Outcome Measures

1. Assess the efficacy of the study drug in terms of incidence of CR and CRp. [Part 1 and Part 2]

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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 17 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Key Inclusion Criteria (Part 2):

• Patients with either Intermediate-2 or High risk MDS or with AML (>20% bone marrow blasts) with stable low or normal white blood cell count (WBC). Patients should have failed one prior chemotherapy regimen which should have included a hypomethylating agent.

• Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1 or 2.

• Discontinuation of prior treatment at least 2 weeks prior to the start of the study.

• Adequate hepatic and renal function.

• Additional criteria exist.

Key Exclusion Criteria (Part 2):

• Concurrent cytotoxic therapy, or biological, endocrine and immunological response modifiers.

• Previous radiation to >25% of bone marrow.

• Other active malignancies.

• Known positive serology for the human immunodeficiency virus (HIV).

• Central nervous system involvement as documented by spinal fluid cytology.

• Active, uncontrolled infection.

• Additional criteria exist

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Emory University School of Medicine, Winship Cancer Center	Atlanta	Georgia	United States	30322
2	University of Texas, M.D. Anderson Cancer Center	Houston	Texas	United States	77030

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT00637052
• Other Study ID Numbers: ARRAY-520-211; C4371005
• First Posted: Mar 17, 2008
• Last Update Posted: Feb 8, 2021
• Last Verified: Feb 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by Pfizer: preleukemia; dysplasia of myeloid blood cells
• Additional relevant MeSH terms: Leukemia; Leukemia, Myeloid; Filanesib

Study Results

No Results Posted as of Feb 8, 2021