Phase I/II Study of ARRY-520 in Subjects With Advanced Leukemia - Full Text View

Sponsored by:	Array BioPharma
Information provided by:	Array BioPharma
ClinicalTrials.gov Identifier:	NCT00637052

Purpose

ARRY-520 is designed to prevent cancer cells from reproducing. By preventing the tumor cells from reproducing, ARRY-520 may slow the spread of the cancer cells and may cause them to die. ARRAY-520-211is a study meant for patients with AML, advanced MDS, CMML, and CML-BP cancers refractory to standard treatment. In the first part of this study, patients will receive increasing doses on different schedules of a novel kinesin spindle protein inhibitor (KSP inhibitor) in order to achieve the highest dose possible that will not cause unacceptable side effects. In the second part of the study, a larger group of patients will receive the best dose and schedule determined from the first part of the study. Both groups of patients will be followed to see what side effects ARRY-520 causes and to see what effectiveness it has, if any in treating the cancer.

Condition	Intervention	Phase
Advanced Leukemia	Drug: ARRY-520	Phase I Phase II

MedlinePlus related topics: Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study
Official Title:	A Phase I/II Study of ARRY-520 in Patients With Advanced Myeloid Leukemia

Further study details as provided by Array BioPharma:

Primary Outcome Measures:

To evaluate the safety of ARRY-520, in terms of Adverse Events, Dose Limiting Toxicity, Clinical laboratory tests, Weight, ECG, and Physical examinations. [ Time Frame: Phase I/II ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To evaluate pharmacokinetic parameters, including serial drug levels and trough concentrations. [ Time Frame: Phase I ] [ Designated as safety issue: No ]
To evaluate pharmacodynamic parameters, including serum nucleosomes, WBC IHC, and basal cytokine levels. [ Time Frame: Phase I/II ] [ Designated as safety issue: No ]
To evaluate efficacy parameters, in terms of incidence of CR and CRp. [ Time Frame: Phase I/II ] [ Designated as safety issue: No ]

Estimated Enrollment:	97
Study Start Date:	February 2008
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Schedule 1: Experimental	Drug: ARRY-520 Intravenous (IV)
Schedule 2: Experimental	Drug: ARRY-520 Intravenous (IV)

Eligibility

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

Criteria

Inclusion Criteria:

Phase I

Documented AML (including RAEB-t), advanced MDS, CMML and CML-BP - Relapsed or refractory disease or confirmed new diagnosis in patients not receiving standard treatment

Phase II

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

Both Phases

ECOG Status 0-2
Discontinue prior treatment at least 2 weeks prior to the start of the study
Adequate hepatic and renal function
Additional inclusion criteria exists

Exclusion Criteria:

Concurrent cytotoxic therapy, or biological, endocrine and immunological response modifiers
Previous radiation to >25% of bone marrow
Other active malignancies
Known HIV positive
CNS involvement as documented by spinal fluid cytology
Active, uncontrolled infection
Other exclusion criteria exists

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	Recruiting
Atlanta, Georgia, United States, 30322
Contact: Mersiha Torlak 404-778-4582 mhotic@emory.edu
Principal Investigator: Jean Khoury, MD
United States, Texas
University of Texas, M.D. Anderson Cancer Center	Recruiting
Houston, Texas, United States, 77030
Contact: Maria Foudray, RN 713-563-1364 mcfoudra@mdanderson.org
Principal Investigator: Hagop Kantarjian, MD

Sponsors and Collaborators

Array BioPharma

More Information

No publications provided

Responsible Party:	Array BioPharma ( Selena Rush, Senior Clinical Program Manager )
Study ID Numbers:	ARRAY-520-211
Study First Received:	February 22, 2008
Last Updated:	January 20, 2009
ClinicalTrials.gov Identifier:	NCT00637052 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Leukemia
Leukemia, Myeloid

Additional relevant MeSH terms:

Leukemia
Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on May 07, 2009