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Study of Voreloxin in Older Patients With Untreated Acute Myeloid Leukemia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sunesis Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00607997
First received: January 23, 2008
Last updated: June 5, 2012
Last verified: June 2012
History of Changes

January 23, 2008
June 5, 2012
April 2008
March 2010   (final data collection date for primary outcome measure)
To assess the efficacy of voreloxin [ Time Frame: 2 years ] [ Designated as safety issue: No ]
To assess the efficacy of SNS-595 [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00607997 on ClinicalTrials.gov Archive Site
  • Safety [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Survival [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Pharmacokinetics [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Evaluate potential biomarkers [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Safety [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Survival [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Pharmacokinetics [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Evaluate potential biomarkers [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Study of Voreloxin in Older Patients With Untreated Acute Myeloid Leukemia
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

This study will evaluate the overall remission rate of treatment with voreloxin Injection in patients at least 60 years of age with previously untreated AML

Other objectives of this study include:

  1. Safety
  2. Survival
  3. Pharmacokinetics
  4. Evaluate potential biomarkers
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Leukemia
  • Acute Disease
  • Acute Myeloid Leukemia
  • Nonlymphocytic Leukemia
  • Myelodysplastic Syndromes
Drug: voreloxin
All patients receive voreloxin Injection
Experimental: All Study Patients
Intervention: Drug: voreloxin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
116
May 2011
March 2010   (final data collection date for primary outcome measure)

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)
Both
60 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00607997
SPO-0014
No
Sunesis Pharmaceuticals
Sunesis Pharmaceuticals
Not Provided
Study Director: Sunesis Medical Monitor, MD Sunesis Pharmaceuticals
Sunesis Pharmaceuticals
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP