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

Condition(s) targeted: Leukemia; Acute Disease; Acute Myeloid Leukemia; Nonlymphocytic Leukemia; Myelodysplastic Syndromes

Intervention: SNS-595 (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Sunesis Pharmaceuticals

Official(s) and/or principal investigator(s):
Craig Berman, MD, Study Director, Affiliation: Sunesis Pharmaceuticals

Overall contact:
Glenn Michelson, MD, Phone: (650) 266-3733, Email: gmichelson@sunesis.com

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

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

Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Primary outcome: To assess the efficacy of SNS-595

Secondary outcome:

Safety

Survival

Pharmacokinetics

Evaluate potential biomarkers

Detailed description: Other objectives of this study include:

1. Safety

2. Survival

3. Pharmacokinetics

4. Evaluate potential biomarkers

Minimum age: 60 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

1. 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)

2. At least 20% blasts by BM biopsy

3. ECOG performance status of 0,1,or 2

4. Adequate cardiac, renal and liver function

Exclusion Criteria:

1. Uncontrolled DIC

2. Active CNS disease

3. Renal failure requiring dialysis

4. Some prior history of heart attack or stroke (depending on how long ago the event occurred)

Glenn Michelson, MD, Phone: (650) 266-3733, Email: gmichelson@sunesis.com

Scripps Cancer Center, La Jolla, California 92037, United States; Recruiting

Rocky Mountain Blood and Marrow Transplant Program, Denver, Colorado 80218, United States; Recruiting

Cancer Center of Central Connecticut, Southington, Connecticut 064889, United States; Recruiting

The University of Chicago, Chicago, Illinois 60637, United States; Recruiting

Indiana University Cancer Center, Indianapolis, Indiana 46206, United States; Recruiting

St. Francis Hospital & Health Systems at Beech Grove Campus, Indianapolis, Indiana 46237, United States; Recruiting

LSU Health Sciences Center at Shreveport, Shreveport, Louisiana 71103, United States; Recruiting

Dana-Farber Cancer Institute, Boston, Massachusetts 02115, United States; Recruiting

Henry Ford Health System, Detroit, Michigan 48202, United States; Recruiting

University of MO Ellis Fischel Cancer Center, Columbia, Missouri 65203, United States; Recruiting

Hollings Cancer Center at Medical University of South Carolina, Charleston, South Carolina 29425, United States; Recruiting

Vanderbilt-Ingram Cancer Center, Nashville, Tennessee 37232, United States; Recruiting

MD Anderson Cancer Center, Houston, Texas 77030, United States; Recruiting

Huntsman Cancer Institute at the University of Utah, Salt Lake City, Utah 84112, United States; Recruiting

Starting date: April 2008
Ending date: December 2009
Last updated: September 2, 2008