Expired Study
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Boston, Massachusetts 02115


Purpose:

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


Study summary:

Other objectives of this study include: 1. Safety 2. Survival 3. Pharmacokinetics 4. Evaluate potential biomarkers


Criteria:

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)


Study is Available At:


Original ID:

SPO-0014


NCT ID:

NCT00607997


Secondary ID:


Study Acronym:


Brief Title:

Study of Voreloxin in Older Patients With Untreated Acute Myeloid Leukemia


Official Title:

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


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

60 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Sunesis Pharmaceuticals


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Non-Randomized, Endpoint Classificati


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

116


Enrollment Type:

Actual


Overall Contact Information

Official Name:Sunesis Medical Monitor, MD
Study Director
Sunesis Pharmaceuticals

Study Dates

Start Date:April 2008
Completion Date:May 2011
Completion Type:Actual
Primary Completion Date:March 2010
Primary Completion Type:Actual
Verification Date:June 2012
Last Changed Date:June 5, 2012
First Received Date:January 23, 2008

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Evaluate potential biomarkers
Time Frame:1 year
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Pharmacokinetics
Time Frame:1 year
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Survival
Time Frame:2 years
Safety Issues:True
Outcome Type:Secondary Outcome
Measure:Safety
Time Frame:2 years
Safety Issues:True
Outcome Type:Primary Outcome
Measure:To assess the efficacy of voreloxin
Time Frame:2 years
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:voreloxin
Description:All patients receive voreloxin Injection
Arm Name:All Study Patients

Study Arms

Study Arm Type:Experimental
Arm Name:All Study Patients

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Sunesis Pharmaceuticals

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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