Status:
COMPLETED
Study of Vosaroxin or Placebo in Combination With Cytarabine in Patients With First Relapsed or Refractory AML
Lead Sponsor:
Sunesis Pharmaceuticals
Conditions:
Acute Myeloid Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This study compared treatment groups of patients treated with vosaroxin and cytarabine versus patients treated with placebo and cytarabine.
Detailed Description
The study includes additional objectives to ones listed above as Outcome Measures. These additional objectives also compared treatment groups in the following: CR + CRp rate, defined as CR + CRp base...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 17 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2017
Estimated Enrollment :
711 Patients enrolled
Trial Details
Trial ID
NCT01191801
Start Date
December 17 2010
End Date
March 1 2017
Last Update
August 22 2018
Active Locations (124)
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1
Moores UCSD Cancer Center
La Jolla, California, United States, 92093
2
UCLA Division of Hematology/Oncology
Los Angeles, California, United States, 90095
3
Sharp Clinical Oncology Research
San Diego, California, United States, 92123
4
University of California San Francisco
San Francisco, California, United States, 94143