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