Study of Vosaroxin or Placebo in Combination With Cytarabine in Patients With First Relapsed or Refractory AML (VALOR)
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ClinicalTrials.gov Identifier: NCT01191801 |
Recruitment Status :
Completed
First Posted : August 31, 2010
Results First Posted : May 9, 2017
Last Update Posted : August 22, 2018
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Tracking Information | |||||
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First Submitted Date ICMJE | August 27, 2010 | ||||
First Posted Date ICMJE | August 31, 2010 | ||||
Results First Submitted Date ICMJE | April 12, 2016 | ||||
Results First Posted Date ICMJE | May 9, 2017 | ||||
Last Update Posted Date | August 22, 2018 | ||||
Study Start Date ICMJE | December 17, 2010 | ||||
Actual Primary Completion Date | September 26, 2014 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Overall Survival [ Time Frame: Up to 5 years or duration of study ] Vosaroxin + cytarabine patient survival versus placebo + cytarabine patient survival
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Original Primary Outcome Measures ICMJE |
Overall Survival [ Time Frame: Up to 5 years or duration of study ] | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
CR rate [ Time Frame: Up to 5 years or duration of study ] | ||||
Current Other Pre-specified Outcome Measures |
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Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Study of Vosaroxin or Placebo in Combination With Cytarabine in Patients With First Relapsed or Refractory AML | ||||
Official Title ICMJE | A Phase 3, Randomized, Controlled, Double-Blind, Multinational Clinical Study of the Efficacy and Safety of Vosaroxin and Cytarabine Versus Placebo and Cytarabine in Patients With First Relapsed or Refractory Acute Myeloid Leukemia (VALOR) | ||||
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 based on modified IWG response criteria. Combined CR rate (CR+CRp+CRi). Percentage of patients who have post-treatment (subsequent) transplantation. Percentage of patients who received subsequent non-protocol therapy (including transplantation). Safety and tolerability. In keeping with FDA guidance for adaptive trial designs, the study incorporated an independent DSMB (Drug Safety Monitoring Board) to address potential uncertainty concerning the true treatment affect between the treatment groups and to address a deterioration of power from a small difference. Sunesis remained blinded and had no involvement in the interim data analysis, interpretation, or adaptive design. Based on the results of the interim data analysis the DSMB recommended an increase in the target number of deaths from 375 in 450 patients to 562 in 675 patients which based on a 5% dropout rate increased enrollment from 475 to 712. The primary analysis was performed when the target number of deaths had been achieved based on a permuted block randomization procedure, stratified by disease status (refractory, first relapse with duration of first CR or CRp ≥ 90 days and < 12 months, or first relapse with duration of first CR or CRp ≥ 12 months and ≤ 24 months), age (< 60 years or ≥ 60 years), and geographic location (US or outside US). The study included periods of screening, treatment / hematologic recovery, post-treatment follow-up, and long-term follow-up for survival. Follow-up was monthly during the first year, every 2 months during the second year, and every 3 months thereafter until death, withdrawal of consent, or loss to follow-up, whichever occurred first. Long-term follow-up began for all patients when the required number of deaths for primary analysis had been met; thereafter, survival data were collected every 4 months until death, withdrawal of consent, or loss to follow-up, whichever occurred first. The long term follow-up for this study continues at this time and the September 2014 date reflects database lock for primary analyses reflected in the Results Section. During long term follow-up Sunesis is not collecting Adverse Events. |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 3 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Acute Myeloid Leukemia | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Ravandi F, Ritchie EK, Sayar H, Lancet JE, Craig MD, Vey N, Strickland SA, Schiller GJ, Jabbour E, Erba HP, Pigneux A, Horst HA, Recher C, Klimek VM, Cortes J, Roboz GJ, Odenike O, Thomas X, Havelange V, Maertens J, Derigs HG, Heuser M, Damon L, Powell BL, Gaidano G, Carella AM, Wei A, Hogge D, Craig AR, Fox JA, Ward R, Smith JA, Acton G, Mehta C, Stuart RK, Kantarjian HM. Vosaroxin plus cytarabine versus placebo plus cytarabine in patients with first relapsed or refractory acute myeloid leukaemia (VALOR): a randomised, controlled, double-blind, multinational, phase 3 study. Lancet Oncol. 2015 Sep;16(9):1025-1036. doi: 10.1016/S1470-2045(15)00201-6. Epub 2015 Jul 30. | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
711 | ||||
Original Estimated Enrollment ICMJE |
500 | ||||
Actual Study Completion Date ICMJE | March 1, 2017 | ||||
Actual Primary Completion Date | September 26, 2014 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Australia, Austria, Belgium, Canada, Czechia, France, Germany, Hungary, Italy, Korea, Republic of, New Zealand, Poland, Spain, United Kingdom, United States | ||||
Removed Location Countries | Czech Republic | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT01191801 | ||||
Other Study ID Numbers ICMJE | VOS-AML-301 2010-021961-61 ( EudraCT Number ) |
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Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product | Not Provided | ||||
IPD Sharing Statement ICMJE |
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Responsible Party | Sunesis Pharmaceuticals | ||||
Study Sponsor ICMJE | Sunesis Pharmaceuticals | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Sunesis Pharmaceuticals | ||||
Verification Date | March 2017 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |