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NCT00607997 Clinical Trial

Study of Voreloxin in Older Patients With Untreated Acute Myeloid Leukemia

Leukemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00607997
Other study ID # SPO-0014
Secondary ID
Status Completed
Phase Phase 2
First received January 23, 2008
Last updated June 5, 2012
Start date April 2008
Est. completion date May 2011

Study information
Verified date June 2012
Source Sunesis Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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

Description:

Other objectives of this study include:

1. Safety

2. Survival

3. Pharmacokinetics

4. Evaluate potential biomarkers

Recruitment information / eligibility
Status Completed
Enrollment 116
Est. completion date May 2011
Est. primary completion date March 2010
Accepts healthy volunteers No
Gender Both
Age group 60 Years and older
Eligibility 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 or aspirate

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

4. Adequate cardiac, renal and liver function

Exclusion Criteria:

1. Uncontrolled DIC

2. Active central nervous system involvement by AML

3. Requiring hemodialysis or peritoneal dialysis

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• voreloxin
All patients receive voreloxin Injection

Locations
Country Name City State
United States Dana-Farber Cancer Institute Boston Massachusetts
United States Massachusetts General Hospital Boston Massachusetts
United States Hollings Cancer Center at Medical University of South Carolina Charleston South Carolina
United States Rush University Medical Center Chicago Illinois
United States The University of Chicago Chicago Illinois
United States University of MO Ellis Fischel Cancer Center Columbia Missouri
United States Rocky Mountain Blood and Marrow Transplant Program Denver Colorado
United States MD Anderson Cancer Center Houston Texas
United States Indiana University Cancer Center Indianapolis Indiana
United States St. Francis Hospital & Health Systems at Beech Grove Campus Indianapolis Indiana
United States University of Mississippi Medical Center Jackson Mississippi
United States Scripps Cancer Center La Jolla California
United States Vanderbilt-Ingram Cancer Center Nashville Tennessee
United States Mayo Clinic Hospital Phoenix Arizona
United States University of Pittsburgh Cancer Institute Pittsburgh Pennsylvania
United States Huntsman Cancer Institute at the University of Utah Salt Lake City Utah
United States Mayo Clinic Scottsdale Scottsdale Arizona
United States LSU Health Sciences Center at Shreveport Shreveport Louisiana
United States Cancer Center of Kansas Wichita Kansas
United States Cancer Center of Kansas Wichita Kansas

Sponsors (1)
Lead Sponsor Collaborator
Sunesis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary To assess the efficacy of voreloxin 2 years No
Secondary Safety 2 years Yes
Secondary Survival 2 years Yes
Secondary Pharmacokinetics 1 year No
Secondary Evaluate potential biomarkers 1 year No
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