Safety and Tolerability Study of Voreloxin and Cytarabine Combination in Acute Myeloid Leukemia in Humans

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sunesis Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00541866
First received: October 8, 2007
Last updated: June 5, 2012
Last verified: June 2012
  Purpose

This study will evaluate the safety and tolerability of voreloxin injection in combination with cytarabine in patients with relapsed or refractory acute myeloid leukemia.


Condition Intervention Phase
Acute Myeloid Leukemia
Drug: voreloxin injection and cytarabine
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Sunesis Pharmaceuticals:

Primary Outcome Measures:
  • To assess the safety and tolerability of voreloxin and cytarabine combination [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pharmacokinetic (PK) profile of voreloxin and cytarabine combination [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Enrollment: 115
Study Start Date: August 2007
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
All patients entered into 1 arm
Drug: voreloxin injection and cytarabine

Stage 1 - Escalating doses of voreloxin on days 1 and 4 in combination with a 5-day continuous IV (in the vein) infusion dose of 400 mg/m2 cytarabine

Stage 2 - Same as stage 1 except voreloxin administered at the maximum tolerated dose established in stage 1

Other Name: ARA-C, Cytosar-U

Detailed Description:

Other objectives of this study include:

  1. Assess antileukemic activity
  2. Characterize the pharmacokinetic profile
  3. Evaluate potential biomarkers
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00541866

Locations
United States, Colorado
Rocky Mountain Cancer Centers
Denver, Colorado, United States, 80218
HealthOne Presbyterian/St. Luke's Medical Center
Denver, Colorado, United States, 80218
United States, Florida
H. Lee Moffitt Cancer Center
Tampa, Florida, United States, 33612
United States, Illinois
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
Northwestern Medical Faculty Foundation
Chicago, Illinois, United States, 60611
United States, Indiana
Indiana University Cancer Center
Indianapolis, Indiana, United States, 46206
United States, Maryland
Johns Hopkins University - Sidney Kimmel Cancer Center
Baltimore, Maryland, United States, 21205
United States, New York
New York Presbyterian Hospital-Weill Cornell Medical College
New York, New York, United States, 10065
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Sunesis Pharmaceuticals
Investigators
Study Director: Sunesis Medical Monitor, MD Sunesis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Sunesis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00541866     History of Changes
Other Study ID Numbers: SPO-0012
Study First Received: October 8, 2007
Last Updated: June 5, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Sunesis Pharmaceuticals:
Leukemia
Acute Myeloid
Relapsed
Refractory
Cancer
AML
Cytarabine
SNS-595
Phase 1
Voreloxin

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Neoplasms by Histologic Type
Neoplasms
Cytarabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 26, 2014