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

Completed · Phase 3 · Has a placebo group

Conditions studied: Acute Myeloid Leukemia

In brief

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

Key facts

Study ID

NCT01191801

Run by

Sunesis Pharmaceuticals

People needed

711

Starts

2010-12-17

Expected to finish

2017-03-01

Last updated by the study team

2018-08-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• UCLA Division of Hematology/Oncology — Los Angeles, California, United States
• Sharp Clinical Oncology Research — San Diego, California, United States
• University of California San Francisco — San Francisco, California, United States
• HCA HealthONE - Rocky Mountain Blood and Marrow Transplant Program — Denver, Colorado, United States
• George Washington University-Medical Faculty Associates — Washington D.C., District of Columbia, United States
• Holy Cross Hospital — Fort Lauderdale, Florida, United States
• Baptist Cancer Institute — Jacksonville, Florida, United States
• H. Lee Moffitt Cancer Center & Research Institute — Tampa, Florida, United States
• Georgia Health Sciences University — Augusta, Georgia, United States
• Rush University Medical Center, Division of Hematology/Oncology — Chicago, Illinois, United States
• University of Chicago — Chicago, Illinois, United States
• Indiana University Melvin and Bren Simon Cancer Center — Indianapolis, Indiana, United States
• St. Francis Medical Group Oncology and Hematology Specialists — Indianapolis, Indiana, United States
• University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
• Ochsner Clinic Foundation — New Orleans, Louisiana, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Henry Ford Health System — Detroit, Michigan, United States
• Ellis Fischel Cancer Center, University of Missouri Health Care — Columbia, Missouri, United States
• Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States
• John Theurer Cancer Center at Hackensack University Medical Center — Hackensack, New Jersey, United States
• North Shore Long Island Jewish Health System — Lake Success, New York, United States
• Memorial Sloan-Kettering Cancer Center — New York, New York, United States
• Weill Cornell Medical College — New York, New York, United States
• Stony Brook University Medical Center — Stony Brook, New York, United States
• Moores UCSD Cancer Center — La Jolla, California, United States

Full record on ClinicalTrials.gov

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