Study of Voreloxin in Older Patients With Untreated Acute Myeloid Leukemia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sunesis Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00607997
First received: January 23, 2008
Last updated: June 5, 2012
Last verified: June 2012
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Survival [ Time Frame: 2 years ] [ 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 ]

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
  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 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 ClinicalTrials.gov identifier: NCT00607997

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

No publications provided

Responsible Party: Sunesis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00607997     History of Changes
Other Study ID Numbers: SPO-0014
Study First Received: January 23, 2008
Last Updated: June 5, 2012
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

Additional relevant MeSH terms:
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Myelodysplastic Syndromes
Preleukemia
Leukemia
Syndrome
Acute Disease
Neoplasms by Histologic Type
Neoplasms
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Disease
Pathologic Processes
Disease Attributes

ClinicalTrials.gov processed this record on September 29, 2014