Acute Myeloid Leukemia Clinical Trial

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Study of Voreloxin (Vosaroxin) in Older Patients With Untreated Acute Myeloid Leukemia

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Summary

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

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Full Description

Other objectives of this study include:

Assess the safety of treatment with vosaroxin, including the 30 and 60 day all-cause mortality
Assess leukemia free survival (LFS), event-free survival (EFS), overall survival (OS), and duration of remission (DR).
Characterize the pharmacokinetic (PK) profile of vosaroxin in this patient population.
Evaluate potential stratification biomarkers by evaluating DNA-damage and apoptotic pathways in bone marrow samples before and after treatment with vosaroxin

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Eligibility Criteria

Key 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

Key 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)

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 2

Estimated Enrollment:

113

Study ID:

NCT00607997

Recruitment Status:

Completed

Sponsor:

Sunesis Pharmaceuticals

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There are 20 Locations for this study

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

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 2

Estimated Enrollment:

113

Study ID:

NCT00607997

Recruitment Status:

Completed

Sponsor:


Sunesis Pharmaceuticals

How clear is this clinincal trial information?

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