Phase 1b/2, Open-Label, Multicenter, Dose-Escalating, Clinical Study of the Safety, Tolerability, and Pharmacokinetic and Pharmacodynamic Profiles of Voreloxin Injection in Combination With Cytarabine in Patients With Relapsed or Refractory Acute Myeloid Leukemia
18 Years
N/A
Both
Acute Myeloid Leukemia
Trial Information
Phase 1b/2, Open-Label, Multicenter, Dose-Escalating, Clinical Study of the Safety, Tolerability, and Pharmacokinetic and Pharmacodynamic Profiles of Voreloxin Injection in Combination With Cytarabine in Patients With Relapsed or Refractory Acute Myeloid Leukemia
Other objectives of this study include:
1. Assess antileukemic activity
2. Characterize the pharmacokinetic profile
3. Evaluate potential biomarkers
Inclusion Criteria:
- Relapsed or refractory AML subtypes, except acute promyelocytic leukemia (APL)
Exclusion Criteria:
- History of myocardial infarction within 3 months of study treatment
- History of cerebrovascular accident/transient ischemic attack (CVA/TIA) within 3
months of study treatment
- Thromboembolic event (deep vein thrombosis or pulmonary embolus) within 28 days of
study treatment
- Known intolerance to cytarabine or known allergy to D-sorbitol or methanesulfonic
acid
Please note: There are additional inclusion/exclusion criteria for this study. Please
contact the study center for additional information and to determine if all study criteria
are met.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
To assess the safety and tolerability of voreloxin and cytarabine combination
Outcome Time Frame:
2 years
Safety Issue:
Yes
Principal Investigator
Sunesis Medical Monitor, MD
Investigator Role:
Study Director
Investigator Affiliation:
Sunesis Pharmaceuticals
Authority:
United States: Food and Drug Administration
Study ID:
SPO-0012
NCT ID:
NCT00541866
Start Date:
August 2007
Completion Date:
July 2011
Related Keywords:
- Acute Myeloid Leukemia
- Leukemia
- Acute Myeloid
- Relapsed
- Refractory
- Cancer
- AML
- Cytarabine
- SNS-595
- Phase 1
- Voreloxin
- Leukemia
- Leukemia, Myeloid, Acute
- Leukemia, Myeloid
Name | Location |
|---|---|
| MD Anderson Cancer Center | Houston, Texas 77030-4096 |
| Indiana University Cancer Center | Indianapolis, Indiana 46202-5265 |
| Northwestern Memorial Hospital | Chicago, Illinois 60611 |
| Rocky Mountain Cancer Centers | Thornton, Colorado 80260 |
| Northwestern Medical Faculty Foundation | Chicago, Illinois 60611 |
| H. Lee Moffitt Cancer Center | Tampa, Florida 33612 |
| New York Presbyterian Hospital-Weill Cornell Medical College | New York, New York 10021 |
| HealthOne Presbyterian/St. Luke's Medical Center | Denver, Colorado 80218 |
| Johns Hopkins University - Sidney Kimmel Cancer Center | Baltimore, Maryland 21205 |
