Study of Voreloxin in Older Patients With Untreated Acute Myeloid Leukemia - Full Text View

Sponsor:	Sunesis Pharmaceuticals
Information provided by:	Sunesis Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00607997

Purpose

This study will evaluate the overall remission rate of treatment with voreloxin Injection in patients at least 60 years of age with previously untreated AML

Condition	Intervention	Phase
Leukemia Acute Disease Acute Myeloid Leukemia Nonlymphocytic Leukemia Myelodysplastic Syndromes	Drug: voreloxin	Phase II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Control: Uncontrolled Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase 2, Open-Label, Multicenter Clinical Study of the Safety and Efficacy of Voreloxin Injection in Patients Equal to or Greater Than 60 Years of Age With Previously Untreated Acute Myeloid Leukemia

Resource links provided by NLM:

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

Drug Information available for: AG 7352

U.S. FDA Resources

Further study details as provided by Sunesis Pharmaceuticals:

Primary Outcome Measures:

To assess the efficacy of voreloxin [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Survival [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Pharmacokinetics [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Evaluate potential biomarkers [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment:	116
Study Start Date:	April 2008
Estimated Study Completion Date:	March 2011
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
All Study Patients: Experimental	Drug: voreloxin All patients receive voreloxin Injection

Detailed Description:

Other objectives of this study include:

Safety
Survival
Pharmacokinetics
Evaluate potential biomarkers

Eligibility

Ages Eligible for Study:	60 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

At least 60 years of age and diagnosis of previously untreated AML (either de novo or from an antecedent hematologic disorder or therapy related AML)
At least 20% blasts by BM biopsy or aspirate
ECOG performance status of 0,1,or 2
Adequate cardiac, renal and liver function

Exclusion Criteria:

Uncontrolled DIC
Active central nervous system involvement by AML
Requiring hemodialysis or peritoneal dialysis
Some prior history of heart attack or stroke (depending on how long ago the event occurred)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00607997

Locations

United States, Arizona
Mayo Clinic Hospital
Phoenix, Arizona, United States, 85054
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States, 85259
United States, California
Scripps Cancer Center
La Jolla, California, United States, 92037
United States, Colorado
Rocky Mountain Blood and Marrow Transplant Program
Denver, Colorado, United States, 80218
United States, Illinois
The University of Chicago
Chicago, Illinois, United States, 60637
Rush University Medical Center
Chicago, Illinois, United States, 60612
United States, Indiana
Indiana University Cancer Center
Indianapolis, Indiana, United States, 46206
St. Francis Hospital & Health Systems at Beech Grove Campus
Indianapolis, Indiana, United States, 46237
United States, Kansas
Cancer Center of Kansas
Wichita, Kansas, United States, 67214
Cancer Center of Kansas
Wichita, Kansas, United States, 67208
United States, Louisiana
LSU Health Sciences Center at Shreveport
Shreveport, Louisiana, United States, 71103
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
United States, Missouri
University of MO Ellis Fischel Cancer Center
Columbia, Missouri, United States, 65203
United States, Pennsylvania
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States, 15232
United States, South Carolina
Hollings Cancer Center at Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, Tennessee
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030
United States, Utah
Huntsman Cancer Institute at the University of Utah
Salt Lake City, Utah, United States, 84112

Sponsors and Collaborators

Sunesis Pharmaceuticals

Investigators

Study Director:

Glenn Michelson, MD

Sunesis Pharmaceuticals

More Information

No publications provided

Responsible Party:	Sunesis Pharmaceuticals, Inc. ( Glenn Michelson, MD-Medical Monitor )
Study ID Numbers:	SPO-0014
Study First Received:	January 23, 2008
Last Updated:	December 8, 2009
ClinicalTrials.gov Identifier:	NCT00607997 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Sunesis Pharmaceuticals:

Leukemia
Myeloid
Elderly
Hematologic
Blood
Cancer
Malignancy

SNS-595
Sunesis
Hematologic Diseases
Myelodysplastic Syndromes
Older
voreloxin
reveal-1

Additional relevant MeSH terms:

Acute Disease
Disease Attributes
Neoplasms by Histologic Type
Precancerous Conditions
Hematologic Diseases
Myelodysplastic Syndromes
Leukemia, Myeloid

Leukemia, Myeloid, Acute
Leukemia
Preleukemia
Neoplasms
Pathologic Processes
Bone Marrow Diseases

ClinicalTrials.gov processed this record on March 18, 2010