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

Sponsor:	Array BioPharma
Information provided by (Responsible Party):	Array BioPharma
ClinicalTrials.gov Identifier:	NCT00637052

Purpose

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 Approximately 40 patients from the US will be enrolled in Part 3 (Withdrawn).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	Intervention	Phase
Advanced MDS Acute Myeloid Leukemia	Drug: ARRY-520, KSP(Eg5) inhibitor; intravenous	Phase I Phase II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Acute Myeloid Leukemia Cancer Leukemia Myelodysplastic Syndromes

U.S. FDA Resources

Further study details as provided by Array BioPharma:

Primary Outcome Measures:

Establish the maximum tolerated dose (MTD) of the study drug. [ Time Frame: Part 1 ] [ Designated as safety issue: Yes ]
Characterize the pharmacokinetics (PK) of the study drug. [ Time Frame: Part 1 ] [ Designated as safety issue: No ]
Characterize the safety profile of the study drug in terms of adverse events, dose limiting toxicity, clinical laboratory tests, weight, electrocardiograms and physical examinations. [ Time Frame: Part 1 and Part 2 ] [ Designated as safety issue: Yes ]
Assess the efficacy of the study drug in terms of incidence of complete remission (CR) and hematologic improvement (CRp). [ Time Frame: Part 3 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Assess the efficacy of the study drug in terms of incidence of CR and CRp. [ Time Frame: Part 1 and Part 2 ] [ Designated as safety issue: No ]
Characterize the safety profile of the study drug in terms of adverse events, dose limiting toxicity, clinical laboratory tests, weight, electrocardiograms and physical examinations. [ Time Frame: Part 3 ] [ Designated as safety issue: Yes ]

Enrollment:	36
Study Start Date:	February 2008
Study Completion Date:	June 2010
Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

Eligibility

Ages Eligible for Study:	17 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Key Inclusion Criteria (Part 3):

Documented AML or advanced MDS - relapsed or refractory disease or confirmed new diagnosis in patients not receiving standard treatment.
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 3):

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00637052

Locations

United States, Georgia
Emory University School of Medicine, Winship Cancer Center
Atlanta, Georgia, United States, 30322
United States, Texas
University of Texas, M.D. Anderson Cancer Center
Houston, Texas, United States, 77030

Sponsors and Collaborators

Array BioPharma

More Information

No publications provided

Responsible Party:	Array BioPharma
ClinicalTrials.gov Identifier:	NCT00637052 History of Changes
Other Study ID Numbers:	ARRAY-520-211
Study First Received:	February 22, 2008
Last Updated:	January 13, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Array BioPharma:

preleukemia
dysplasia of myeloid blood cells

Additional relevant MeSH terms:

Leukemia
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on February 09, 2012