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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


Phase 2
60 Years
N/A
Not Enrolling
Both
Leukemia, Acute Disease, Acute Myeloid Leukemia, Nonlymphocytic Leukemia, Myelodysplastic Syndromes

Thank you

Trial Information

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


Other objectives of this study include:

1. Safety

2. Survival

3. Pharmacokinetics

4. Evaluate potential biomarkers


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)

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

To assess the efficacy of voreloxin

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Sunesis Medical Monitor, MD

Investigator Role:

Study Director

Investigator Affiliation:

Sunesis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

SPO-0014

NCT ID:

NCT00607997

Start Date:

April 2008

Completion Date:

May 2011

Related Keywords:

  • Leukemia
  • Acute Disease
  • Acute Myeloid Leukemia
  • Nonlymphocytic Leukemia
  • Myelodysplastic Syndromes
  • Leukemia
  • Myeloid
  • Elderly
  • Hematologic
  • Blood
  • Cancer
  • Malignancy
  • SNS-595
  • Sunesis
  • Hematologic Diseases
  • Myelodysplastic Syndromes
  • Older
  • voreloxin
  • reveal-1
  • Acute Disease
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Myelodysplastic Syndromes
  • Preleukemia

Name

Location
MD Anderson Cancer Center Houston, Texas  77030-4096
Mayo Clinic Scottsdale Scottsdale, Arizona  85259
Indiana University Cancer Center Indianapolis, Indiana  46202-5265
University of Mississippi Medical Center Jackson, Mississippi  39216-4505
University of Pittsburgh Cancer Institute Pittsburgh, Pennsylvania  15213
Vanderbilt-Ingram Cancer Center Nashville, Tennessee  37232-6838
Rush University Medical Center Chicago, Illinois  60612-3824
Dana-Farber Cancer Institute Boston, Massachusetts  02115
Hollings Cancer Center at Medical University of South Carolina Charleston, South Carolina  29425
Massachusetts General Hospital Boston, Massachusetts  02114-2617
Mayo Clinic Hospital Phoenix, Arizona  85054-4502
Scripps Cancer Center La Jolla, California  92037
The University of Chicago Chicago, Illinois  60637
Cancer Center of Kansas Wichita, Kansas  67214
Rocky Mountain Blood and Marrow Transplant Program Denver, Colorado  80218
Huntsman Cancer Institute at the University of Utah Salt Lake City, Utah  84112
St. Francis Hospital & Health Systems at Beech Grove Campus Indianapolis, Indiana  46237
LSU Health Sciences Center at Shreveport Shreveport, Louisiana  71103
University of MO Ellis Fischel Cancer Center Columbia, Missouri  65203