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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

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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 CenterHouston, Texas  77030-4096
Mayo Clinic ScottsdaleScottsdale, Arizona  85259
Indiana University Cancer CenterIndianapolis, Indiana  46202-5265
University of Mississippi Medical CenterJackson, Mississippi  39216-4505
University of Pittsburgh Cancer InstitutePittsburgh, Pennsylvania  15213
Vanderbilt-Ingram Cancer CenterNashville, Tennessee  37232-6838
Rush University Medical CenterChicago, Illinois  60612-3824
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Hollings Cancer Center at Medical University of South CarolinaCharleston, South Carolina  29425
Massachusetts General HospitalBoston, Massachusetts  02114-2617
Mayo Clinic HospitalPhoenix, Arizona  85054-4502
Scripps Cancer CenterLa Jolla, California  92037
The University of ChicagoChicago, Illinois  60637
Cancer Center of KansasWichita, Kansas  67214
Rocky Mountain Blood and Marrow Transplant ProgramDenver, Colorado  80218
Huntsman Cancer Institute at the University of UtahSalt Lake City, Utah  84112
St. Francis Hospital & Health Systems at Beech Grove CampusIndianapolis, Indiana  46237
LSU Health Sciences Center at ShreveportShreveport, Louisiana  71103
University of MO Ellis Fischel Cancer CenterColumbia, Missouri  65203