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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sunesis Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01191801
First received: August 27, 2010
Last updated: March 29, 2017
Last verified: March 2017
Results First Received: April 12, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Acute Myeloid Leukemia
Interventions: Drug: vosaroxin + cytarabine
Drug: placebo + cytarabine

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
320 patients enrolled in 30 US sites:391 patients enrolled at 71 sites outside of the US (Canada, Europe, Australia, New Zealand, and Republic of Korea)

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Six patients were randomized but never received treatment due to death prior to beginning treatment: 4 assigned to receive vosaroxin/cytarabine; 2 assigned to receive placebo/cytarabine.

Reporting Groups
  Description
Group A (Vosaroxin/Cytarabine) Vosaroxin on Days 1 and 4 (90 mg/m2 induction 1; 70 mg/m2 all other cycles); cytarabine 1 g/m2 daily on Days 1 through 5
Group B (Placebo/Cytarabine) Placebo (volume matched to vosaroxin) on Days 1 and 4; cytarabine 1 g/m2 daily on Days 1 through 5

Participant Flow:   Overall Study
    Group A (Vosaroxin/Cytarabine)   Group B (Placebo/Cytarabine)
STARTED   356   355 
COMPLETED   40   18 
NOT COMPLETED   316   337 
Death                36                12 
Lack of Efficacy                176                258 
Adverse Event                9                8 
Protocol Violation                2                4 
Physician Decision                47                24 
Withdrawal by Subject                1                4 
Not Provided                45                27 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intent to Treat Population: Patients who were randomized.

Reporting Groups
  Description
Group A (Vosaroxin/Cytarabine) Vosaroxin on Days 1 and 4 (90 mg/m2 induction 1; 70 mg/m2 all other cycles); cytarabine 1 g/m2 daily on Days 1 through 5
Group B (Placebo/Cytarabine) Placebo (volume matched to vosaroxin) on Days 1 and 4; cytarabine 1 g/m2 daily on Days 1 through 5
Total Total of all reporting groups

Baseline Measures
   Group A (Vosaroxin/Cytarabine)   Group B (Placebo/Cytarabine)   Total 
Overall Participants Analyzed 
[Units: Participants]
 356   355   711 
Age 
[Units: Years]
Mean (Standard Deviation)
 61  (11.51)   60.2  (12.49)   60.6  (12.01) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      154  43.3%      163  45.9%      317  44.6% 
Male      202  56.7%      192  54.1%      394  55.4% 
Region of Enrollment 
[Units: Participants]
     
Hungary   8   11   19 
United States   161   159   320 
United Kingdom   15   10   25 
Spain   9   8   17 
New Zealand   4   3   7 
Canada   10   10   20 
Czech Republic   5   6   11 
Austria   4   4   8 
Belgium   17   19   36 
Poland   3   1   4 
Korea, Republic of   10   5   15 
Italy   20   18   38 
Australia   25   20   45 
France   38   50   88 
Germany   27   31   58 


  Outcome Measures
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1.  Primary:   Overall Survival   [ Time Frame: Up to 5 years or duration of study ]

2.  Secondary:   Complete Remission (CR) Rate Based on Modified International Working Group (IWG) Criteria.   [ Time Frame: Up to 5 years or duration of study ]

3.  Secondary:   All Cause Mortality   [ Time Frame: 30 Days ]

4.  Secondary:   All Cause Mortality   [ Time Frame: 60 Days ]

5.  Other Pre-specified:   Overall Remission (OR) Rate Based on the IWG Response Criteria   [ Time Frame: Up to 5 years or the duration of the study ]

6.  Other Pre-specified:   Event Free Survival (EFS)   [ Time Frame: Up to 5 years or duration of study ]

7.  Other Pre-specified:   Leukemia-Free Survival (LFS)   [ Time Frame: Up to 5 years or the duration of the study ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Linda Neuman, Vice President, Clinical Development
Organization: Sunesis Pharmaceuticals, Inc
phone: (650) 266-3760
e-mail: lneuman@sunesis.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Sunesis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01191801     History of Changes
Other Study ID Numbers: VOS-AML-301
2010-021961-61 ( EudraCT Number )
Study First Received: August 27, 2010
Results First Received: April 12, 2016
Last Updated: March 29, 2017