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Study of Voreloxin in Older Patients With Untreated Acute Myeloid Leukemia

This study has been completed.
Information provided by (Responsible Party):
Sunesis Pharmaceuticals Identifier:
First received: January 23, 2008
Last updated: June 5, 2012
Last verified: June 2012
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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
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:

Further study details as provided by Sunesis Pharmaceuticals:

Primary Outcome Measures:
  • To assess the efficacy of voreloxin [ Time Frame: 2 years ]

Secondary Outcome Measures:
  • Safety [ Time Frame: 2 years ]
  • Survival [ Time Frame: 2 years ]
  • Pharmacokinetics [ Time Frame: 1 year ]
  • Evaluate potential biomarkers [ Time Frame: 1 year ]

Enrollment: 116
Study Start Date: April 2008
Study Completion Date: May 2011
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: All Study Patients Drug: voreloxin
All patients receive voreloxin Injection

Detailed Description:

Other objectives of this study include:

  1. Safety
  2. Survival
  3. Pharmacokinetics
  4. Evaluate potential biomarkers

Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00607997

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
Rush University Medical Center
Chicago, Illinois, United States, 60612
The University of Chicago
Chicago, Illinois, United States, 60637
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, 67208
Cancer Center of Kansas
Wichita, Kansas, United States, 67214
United States, Louisiana
LSU Health Sciences Center at Shreveport
Shreveport, Louisiana, United States, 71103
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
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
Study Director: Sunesis Medical Monitor, MD Sunesis Pharmaceuticals
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Sunesis Pharmaceuticals Identifier: NCT00607997     History of Changes
Other Study ID Numbers: SPO-0014
Study First Received: January 23, 2008
Last Updated: June 5, 2012

Keywords provided by Sunesis Pharmaceuticals:
Hematologic Diseases
Myelodysplastic Syndromes

Additional relevant MeSH terms:
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Myelodysplastic Syndromes
Acute Disease
Neoplasms by Histologic Type
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Disease Attributes
Pathologic Processes processed this record on June 26, 2017