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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


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Acute Myeloid Leukemia

Thank you

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 CenterHouston, Texas  77030-4096
Indiana University Cancer CenterIndianapolis, Indiana  46202-5265
Northwestern Memorial HospitalChicago, Illinois  60611
Rocky Mountain Cancer CentersThornton, Colorado  80260
Northwestern Medical Faculty FoundationChicago, Illinois  60611
H. Lee Moffitt Cancer CenterTampa, Florida  33612
New York Presbyterian Hospital-Weill Cornell Medical CollegeNew York, New York  10021
HealthOne Presbyterian/St. Luke's Medical CenterDenver, Colorado  80218
Johns Hopkins University - Sidney Kimmel Cancer CenterBaltimore, Maryland  21205