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Study of Voreloxin (Vosaroxin) in Older Patients With Untreated Acute Myeloid Leukemia | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Study of Voreloxin (Vosaroxin) in Older Patients With Untreated Acute Myeloid Leukemia

A Phase 2, Open-Label, Multicenter Clinical Study of the Safety and Efficacy of Voreloxin (Vosaroxin) Injection in Patients Equal to or Greater Than 60 Years of Age With Previously Untreated Acute Myeloid Leukemia

NCT00607997•Sunesis Pharmaceuticals

View on ClinicalTrials.gov

Summary

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

Detailed Description

Other objectives of this study include: 1. Assess the safety of treatment with vosaroxin, including the 30 and 60 day all-cause mortality 2. Assess leukemia free survival (LFS), event-free survival (EFS), overall survival (OS), and duration of remission (DR). 3. Characterize the pharmacokinetic (PK) profile of vosaroxin in this patient population. 4. Evaluate potential stratification biomarkers by evaluating DNA-damage and apoptotic pathways in bone marrow samples before and after treatment with vosaroxin

Eligibility

Age

60 - No limit years

Sex

ALL

Healthy Volunteers

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)

Locations (20)

Mayo Clinic Hospital

Phoenix, Arizona, United States

Mayo Clinic Scottsdale

Scottsdale, Arizona, United States

Scripps Cancer Center

La Jolla, California, United States

Rocky Mountain Blood and Marrow Transplant Program

Denver, Colorado, United States

Rush University Medical Center

Chicago, Illinois, United States

The University of Chicago

Chicago, Illinois, United States

Indiana University Cancer Center

Indianapolis, Indiana, United States

St. Francis Hospital & Health Systems at Beech Grove Campus

Indianapolis, Indiana, United States

Cancer Center of Kansas

Wichita, Kansas, United States

Cancer Center of Kansas

Wichita, Kansas, United States

Key Dates

Start Date

May 15, 2008

Primary Completion Date

November 1, 2009

Completion Date

November 23, 2009

Last Updated

June 28, 2017

Enrollment

113

ACTUAL participants

Conditions

LeukemiaAcute DiseaseAcute Myeloid LeukemiaNonlymphocytic LeukemiaMyelodysplastic Syndromes

Interventions

vosaroxin

DRUG

Phase I Study of HC-7366 for Acute Myeloid Leukemia

NCT06285890

Acute Myeloid Leukemia

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RECRUITINGPHASE1

Azacitidine and Abatacept in Relapsed or Refractory T-Cell Lymphoma

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Lymphoma, T Cell, PeripheralT-cell Lymphoma+4 more

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RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 28, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Study of Voreloxin (Vosaroxin) in Older Patients With Untreated Acute Myeloid Leukemia

Inclusion Criteria

Exclusion Criteria

Phase I Study of HC-7366 for Acute Myeloid Leukemia

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Long-term Evaluation and Follow-up Care of Patients Treated With Stem Cell Transplants

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