Study of SNS-595 in Older Patients With Untreated Acute Myeloid Leukemia - Full Text View

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

Purpose

This study will evaluate the overall remission rate of treatment with SNS 595 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: SNS-595	Phase II

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

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase 2 Open-Label, Multicenter Clinical Study of the Safety and Efficacy of SNS-595 Injection in Patients Equal to or Greater Than 60 Years of Age With Previously Untreated Acute Myeloid Leukemia

Further study details as provided by Sunesis Pharmaceuticals:

Primary Outcome Measures:

To assess the efficacy of SNS-595 [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Survival [ Time Frame: 1 year ] [ 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 ]

Estimated Enrollment:	115
Study Start Date:	April 2008
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
All Study Patients: Experimental	Drug: SNS-595 All patients receive SNS-595 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
ECOG performance status of 0,1,or 2
Adequate cardiac, renal and liver function

Exclusion Criteria:

Uncontrolled DIC
Active CNS disease
Renal failure requiring 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

Contacts

Contact: Glenn Michelson, MD

1-877-767-7672

clinicaltrials@sunesis.com

Locations

United States, California
Scripps Cancer Center	Recruiting
La Jolla, California, United States, 92037
United States, Colorado
Rocky Mountain Blood and Marrow Transplant Program	Recruiting
Denver, Colorado, United States, 80218
United States, Connecticut
Cancer Center of Central Connecticut	Recruiting
Southington, Connecticut, United States, 064889
United States, Illinois
The University of Chicago	Recruiting
Chicago, Illinois, United States, 60637
United States, Indiana
Indiana University Cancer Center	Recruiting
Indianapolis, Indiana, United States, 46206
St. Francis Hospital & Health Systems at Beech Grove Campus	Recruiting
Indianapolis, Indiana, United States, 46237
United States, Louisiana
LSU Health Sciences Center at Shreveport	Recruiting
Shreveport, Louisiana, United States, 71103
United States, Massachusetts
Dana-Farber Cancer Institute	Recruiting
Boston, Massachusetts, United States, 02115
United States, Michigan
Henry Ford Health System	Recruiting
Detroit, Michigan, United States, 48202
United States, Missouri
University of MO Ellis Fischel Cancer Center	Recruiting
Columbia, Missouri, United States, 65203
United States, South Carolina
Hollings Cancer Center at Medical University of South Carolina	Recruiting
Charleston, South Carolina, United States, 29425
United States, Tennessee
Vanderbilt-Ingram Cancer Center	Recruiting
Nashville, Tennessee, United States, 37232
United States, Texas
MD Anderson Cancer Center	Recruiting
Houston, Texas, United States, 77030
United States, Utah
Huntsman Cancer Institute at the University of Utah	Recruiting
Salt Lake City, Utah, United States, 84112

Sponsors and Collaborators

Sunesis Pharmaceuticals

Investigators

Study Director:

Craig Berman, MD

Sunesis Pharmaceuticals

More Information

Responsible Party:	Sunesis Pharmaceuticals ( Craig Berman, MD-Medical Monitor )
Study ID Numbers:	SPO-0014
Study First Received:	January 23, 2008
Last Updated:	December 2, 2008
ClinicalTrials.gov Identifier:	NCT00607997
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

Study placed in the following topic categories:

Acute Disease
Myelodysplastic syndromes
Precancerous Conditions
Hematologic Diseases
Myelodysplastic Syndromes
Myelodysplasia
Acute myelogenous leukemia

Leukemia, Myeloid
Leukemia, Myeloid, Acute
Leukemia
Preleukemia
Bone Marrow Diseases
Acute myelocytic leukemia

Additional relevant MeSH terms:

Neoplasms
Disease Attributes
Disease

Neoplasms by Histologic Type
Pathologic Processes
Syndrome

ClinicalTrials.gov processed this record on January 16, 2009