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

NCT00637052 | Completed Phase 1

• 2 other identifiers: ARRAY-520-211C4371005
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 2

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 Approximately 40 patients from the US will be enrolled in Part 3 (Withdrawn).

Conditions

Advanced MDS; Acute Myeloid Leukemia

Keywords

preleukemia; dysplasia of myeloid blood cells

Outcome Measures

Primary Outcomes (4)

• Establish the maximum tolerated dose (MTD) of the study drug.

  Part 1

• Characterize the pharmacokinetics (PK) of the study drug.

  Part 1

• 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

• Assess the efficacy of the study drug in terms of incidence of complete remission (CR) and hematologic improvement (CRp).

  Part 3

Secondary Outcomes (2)

• 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

Study Arms (1)

ARRY-520

EXPERIMENTAL

Drug: ARRY-520, KSP(Eg5) inhibitor; intravenous

Interventions

ARRY-520, KSP(Eg5) inhibitor; intravenous DRUG

Part 1: multiple dose, escalating; Part 2: multiple dose, single schedule; Part 3: multiple dose, single schedule.

ARRY-520

Eligibility Criteria

• Age: 17 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (2)

Emory University School of Medicine, Winship Cancer Center

Atlanta, Georgia, 30322, United States

Location

University of Texas, M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Khoury HJ, Garcia-Manero G, Borthakur G, Kadia T, Foudray MC, Arellano M, Langston A, Bethelmie-Bryan B, Rush S, Litwiler K, Karan S, Simmons H, Marcus AI, Ptaszynski M, Kantarjian H. A phase 1 dose-escalation study of ARRY-520, a kinesin spindle protein inhibitor, in patients with advanced myeloid leukemias. Cancer. 2012 Jul 15;118(14):3556-64. doi: 10.1002/cncr.26664. Epub 2011 Dec 2.

  PMID: 22139909 DERIVED

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Preleukemia

Interventions

filanesib

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Precancerous Conditions

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2008
• First Posted: March 17, 2008
• Study Start: March 18, 2008
• Primary Completion: June 21, 2010
• Study Completion: June 21, 2010
• Last Updated: February 8, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will share

Locations

US (2)