Study of Vosaroxin or Placebo in Combination With Cytarabine in Patients With First Relapsed or Refractory AML

• Status: Completed
• Trial end date: 2017-03-01
• Target enrollment: 0
• Participant gender: All

Summary

This study compared treatment groups of patients treated with vosaroxin and cytarabine versus patients treated with placebo and cytarabine.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sunesis Pharmaceuticals
• Treatments: Cytarabine

Criteria

Inclusion Criteria:

• Provided signed, written informed consent

• At least 18 years of age

• Had a diagnosis of AML according to World Health Organization (WHO) classification

• First relapsed or refractory AML (refractory to initial induction therapy) with at least 5% blasts by bone marrow or aspirate or 1% blasts in peripheral blood with additional requirements for relapsed or refractory

• Had an ECOG score of 0-2

• Had adequate liver and renal function as indicated by certain laboratory values

• Had adequate cardiac function (left ventricular ejection fraction at least 40% by multiple gated acquisition scan or ECG)

• Nonfertile or agreed to use an adequate method of contraception until 30 days after the last treatment

• Had any clinically significant nonhematologic toxicity after prior chemotherapy recovered to Grade 1 per NCI-CTCAE

Exclusion Criteria:

• Had acute promyelocytic leukemia

• Had more than 2 cycles of induction therapy for AML

• Had completed a single cycle of treatment containing a total dose of 5 g/m2 or more of cytarabine within 90 days before randomization

• Refractory to or relapsed within the previous 3 months after therapy with an IDAC- or HIDAC-containing regimen

• Had received a hematopoietic stem cell transplant (HSCT) within the previous 90 days

• Had received active immunosuppressive therapy for graft-versus-host disease (GVHD) within 2 weeks before study start

• Had any other severe concurrent disease, or have a history of serious disease involving the heart, kidney, liver, or other organ system

• Had evidence of central nervous system involvement of active AML

• Had other active malignancies (including other hematologic malignancies) or been diagnosed with other malignancies within the last 12 months, except nonmelanoma skin cancer or cervical intraepithelial neoplasia

• Had an active, uncontrolled infection

• Had received any other investigational therapy within 14 days or not recovered from acute affects of the other investigational therapy

• Had received prior or current hydroxyurea or medications to reduce blast count within 24 hours before randomization

• Had received previous treatment with vosaroxin

• Pregnant or lactating

• Had any other medical, psychological, or social condition that may interfere with consent, study participation, or follow-up

• Had known HIV seropositivity