ARRY-614 in Patients With Low or Intermediate-1 Risk Myelodysplastic Syndrome

This study is currently recruiting participants.

Verified by Array BioPharma, January 2010

First Received: June 3, 2009 Last Updated: January 19, 2010 History of Changes

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

Purpose

This is a dose-escalation study to determine the maximum tolerated dose (MTD) of ARRY-614 in patients with Myelodysplastic Syndrome (MDS).

Condition	Intervention	Phase
Myelodysplastic Syndrome	Drug: ARRY-614	Phase I

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment
Official Title:	A Phase 1 Study of Oral ARRY-614 in Patients With Low or Intermediate-1 Risk Myelodysplastic Syndrome

Further study details as provided by Array BioPharma:

Primary Outcome Measures:

The safety profile and the maximum tolerated dose (MTD) of study drug as determined by dose-limiting toxicities [ Time Frame: Until MTD is reached ] [ Designated as safety issue: Yes ]
Plasma pharmacokinetic parameters of study drug [ Time Frame: Until MTD is reached ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The preliminary efficacy of study drug [ Time Frame: Until MTD is reached ] [ Designated as safety issue: No ]

Estimated Enrollment:	50
Study Start Date:	June 2009
Estimated Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Study drug: Experimental Escalating doses	Drug: ARRY-614

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

History of bone marrow transplant
Concomitant malignancies or previous malignancies with less than a 2-year disease-free interval at the time of enrollment
Use of an investigational agent 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 for HIV, Hepatitis C and/or active Hepatitis B

Contacts and Locations

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

Locations

United States, Florida
Moffitt Cancer Center	Recruiting
Tampa, Florida, United States, 33612
Contact: Michelle Burton, RN, BSN 813-745-3965 burtonmk@moffitt.org
Principal Investigator: Rami Komrokji, MD
United States, Georgia
Winship Cancer Institute	Recruiting
Atlanta, Georgia, United States, 30322
Contact: Mersiha Torlak 404-778-4582
Principal Investigator: H. Jean Khoury, MD
United States, Texas
MD Anderson Cancer Center	Recruiting
Houston, Texas, United States, 77030
Contact: Maria Cielo Foudray 713-563-1364 mcfoudra@mdanderson.org
Principal Investigator: Guillermo Garcia-Manero, MD

Sponsors and Collaborators

Array BioPharma

More Information

No publications provided

Responsible Party:	Array BioPharma Inc. ( Diane Nemchak, Executive Assistant )
Study ID Numbers:	ARRAY-614-111
Study First Received:	June 3, 2009
Last Updated:	January 19, 2010
ClinicalTrials.gov Identifier:	NCT00916227 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Array BioPharma:

Low or Intermediate-1 Risk Myelodysplastic Syndrome

Additional relevant MeSH terms:

Neoplasms
Preleukemia
Pathologic Processes
Disease
Precancerous Conditions

Hematologic Diseases
Syndrome
Myelodysplastic Syndromes
Bone Marrow Diseases

ClinicalTrials.gov processed this record on February 08, 2010