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

Sunesis Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Acute Disease; Leukemia; Myelodysplastic Syndromes; Acute Myeloid Leukemia; Nonlymphocytic Leukemia

Treatments: Drug: vosaroxin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00607997

SPO-0014

Details and patient eligibility

About

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

Full 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

Enrollment: 113 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key 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

Key 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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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113 participants in 1 patient group

All Study Patients

Experimental group

Description:

* Schedule A: 72 mg/m2 vosaroxin Days 1, 8 and 15 * Schedule B: 72 mg/m2 vosaroxin on Days 1 and 8 * Schedule C: 72 mg/m2 on Days 1 and 4, or * Schedule C: 90 mg/m2 on Days 1 and 4

Treatment:

Drug: vosaroxin