A Study of ARRY-614 in Patients With Low or Intermediate-1 Risk Myelodysplastic Syndrome - Full Text View

Sponsor:	Array BioPharma
Information provided by:	Array BioPharma
ClinicalTrials.gov Identifier:	NCT00916227

Purpose

This is a Phase 1 study during which patients with low or intermediate-1 risk myelodysplastic syndrome (MDS) will receive investigational study drug ARRY-614.

This study has 2 parts. In the first part, patients will receive increasing doses of study drug, given either with food or without food, in order to achieve the highest dose of the study drug possible that will not cause unacceptable side effects. Approximately 60 patients from the US will be enrolled in Part 1 (Active, not recruiting).

In the second part of this study, patients will receive the best dose of study drug, given either with food or without food, determined from the first part of the study and will be followed to see what side effects and effectiveness the study drug has, if any, in treating the cancer. Approximately 40 patients from the US will be enrolled in Part 2 (Active, not recruiting).

Condition	Intervention	Phase
Myelodysplastic Syndromes	Drug: ARRY-614, p38/Tie2 inhibitor; oral	Phase I

Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Cancer Myelodysplastic Syndromes

U.S. FDA Resources

Further study details as provided by Array BioPharma:

Primary Outcome Measures:

Characterize the safety profile of the study drug, in either the fasted or fed state, in terms of adverse events, clinical laboratory tests and electrocardiograms. [ Time Frame: Part 1, one year; Part 2, one year ] [ Designated as safety issue: Yes ]
Establish the maximum tolerated dose (MTD) of the study drug. [ Time Frame: Part 1, one year ] [ Designated as safety issue: Yes ]
Characterize the pharmacokinetics of the study drug and a metabolite under either fasted or fed conditions. [ Time Frame: Part 1, one year; Part 2, one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Assess the efficacy of study drug in terms of response, duration of response and hematologic improvement. [ Time Frame: Part 1, one year; Part 2, one year ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	June 2009
Estimated Study Completion Date:	January 2012
Estimated Primary Completion Date:	January 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: ARRY-614	Drug: ARRY-614, p38/Tie2 inhibitor; oral Part 1: multiple dose, escalating; Part 2: multiple dose, single schedule.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Key Inclusion Criteria (Part 1 and Part 2):

Diagnosis of MDS by bone marrow biopsy.
International Prognostic Scoring System (IPSS) score of low or intermediate-1 risk MDS.
May have received prior therapy for MDS.
Eastern Cooperative Oncology Group (ECOG) performance status (PS) between 0 and 2.
Adequate liver and renal function.
Additional criteria exist.

Key Exclusion Criteria (Part 1 and Part 2):

History of bone marrow transplant.
Concomitant malignancies or previous malignancies with less than a 2-year disease-free interval at the time of enrollment.
Treatment with an investigational medicinal product that is not expected to be cleared by the first dose of study drug or that has demonstrated to have late side effects.
Known positive serology for the human immunodeficiency virus (HIV), hepatitis C and/or active hepatitis B.
Additional criteria exist.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00916227

Locations

United States, Florida
Moffitt Cancer Center
Tampa, Florida, United States, 33612
United States, Georgia
Winship Cancer Institute
Atlanta, Georgia, United States, 30322
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030

Sponsors and Collaborators

Array BioPharma

More Information

No publications provided

Responsible Party:	Clinical Trial Call Center: 303-381-6604, Array BioPharma
ClinicalTrials.gov Identifier:	NCT00916227 History of Changes
Other Study ID Numbers:	ARRAY-614-111
Study First Received:	June 3, 2009
Last Updated:	June 16, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Array BioPharma:

Low or Intermediate-1 Risk Myelodysplastic Syndrome

Additional relevant MeSH terms:

Myelodysplastic Syndromes
Preleukemia
Bone Marrow Diseases

Hematologic Diseases
Precancerous Conditions
Neoplasms

ClinicalTrials.gov processed this record on February 09, 2012