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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01191801
Recruitment Status : Completed
First Posted : August 31, 2010
Results First Posted : May 9, 2017
Last Update Posted : August 22, 2018
Sponsor:
Information provided by (Responsible Party):
Sunesis Pharmaceuticals

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
Enrollment 711
Recruitment Details 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 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.
Arm/Group Title Group A (Vosaroxin/Cytarabine) Group B (Placebo/Cytarabine)
Hide Arm/Group Description 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 Placebo (volume matched to vosaroxin) on Days 1 and 4; cytarabine 1 g/m2 daily on Days 1 through 5
Period Title: Overall Study
Started 356 355
Completed 40 18
Not Completed 316 337
Reason Not Completed
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
Arm/Group Title Group A (Vosaroxin/Cytarabine) Group B (Placebo/Cytarabine) Total
Hide Arm/Group Description 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 Placebo (volume matched to vosaroxin) on Days 1 and 4; cytarabine 1 g/m2 daily on Days 1 through 5 Total of all reporting groups
Overall Number of Baseline Participants 356 355 711
Hide Baseline Analysis Population Description
Intent to Treat Population: Patients who were randomized.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 356 participants 355 participants 711 participants
61  (11.51) 60.2  (12.49) 60.6  (12.01)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 356 participants 355 participants 711 participants
Female
154
  43.3%
163
  45.9%
317
  44.6%
Male
202
  56.7%
192
  54.1%
394
  55.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 356 participants 355 participants 711 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
1.Primary Outcome
Title Overall Survival
Hide Description Vosaroxin + cytarabine patient survival versus placebo + cytarabine patient survival
Time Frame Up to 5 years or duration of study
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population which consists of all patients enrolled (randomly assigned to treatment group).
Arm/Group Title Group A (Vosaroxin/Cytarabine) Group B (Placebo/Cytarabine)
Hide Arm/Group Description:
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
Placebo (volume matched to vosaroxin) on Days 1 and 4; cytarabine 1 g/m2 daily on Days 1 through 5
Overall Number of Participants Analyzed 356 355
Median (95% Confidence Interval)
Unit of Measure: Months
7.5
(6.4 to 8.5)
6.1
(5.2 to 7.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group A (Vosaroxin/Cytarabine), Group B (Placebo/Cytarabine)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0305
Comments Unstratified one sided P-Value
Method Unstratified Log Rank
Comments Since the sample size was increased, the primary analysis used the weighted statistic proposed by Cui, Hung, and Wang (Cui 1999).
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 0.87
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Complete Remission (CR) Rate Based on Modified International Working Group (IWG) Criteria.
Hide Description Group A (Vosaroxin + cytarabine) patient CR as compared to Group B (placebo + cytarabine) patient CR. Complete remission (CR) is typically defined using IWG criteria as bone marrow blast count of less than 5% with adequate recovery of peripheral blood counts.
Time Frame Up to 5 years or duration of study
Hide Outcome Measure Data
Hide Analysis Population Description
The percentage of patients who achieved CR was adjudicated by the CPARR (Central Pathology and Response Review) panel using modified IWG response criteria. The outcome measure reflects the Intent to Treat Population.
Arm/Group Title Group A (Vosaroxin/Cytarabine) Group B (Placebo/Cytarabine)
Hide Arm/Group Description:
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
Placebo (volume matched to vosaroxin) on Days 1 and 4; cytarabine 1 g/m2 daily on Days 1 through 5
Overall Number of Participants Analyzed 356 355
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of particpants
30.1
(25.3 to 35.1)
16.3
(12.6 to 20.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group A (Vosaroxin/Cytarabine), Group B (Placebo/Cytarabine)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Two sided P-Value
Method Chi-squared
Comments [Not Specified]
3.Secondary Outcome
Title All Cause Mortality
Hide Description Vosaroxin + cytarabine mortality versus placebo + cytarabine mortality
Time Frame 30 Days
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population (705)
Arm/Group Title Group A (Vosaroxin/Cytarabine) Group B (Placebo/Cytarabine)
Hide Arm/Group Description:
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
Placebo (volume matched to vosaroxin) on Days 1 and 4; cytarabine 1 g/m2 daily on Days 1 through 5
Overall Number of Participants Analyzed 355 350
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of Participants in the Group
7.9
(5.3 to 11.2)
6.6
(4.2 to 9.7)
4.Secondary Outcome
Title All Cause Mortality
Hide Description Vosaroxin + cytarabine mortality versus placebo + cytarabine mortality
Time Frame 60 Days
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population (705)
Arm/Group Title Group A (Vosaroxin/Cytarabine) Group B (Placebo/Cytarabine)
Hide Arm/Group Description:
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
Placebo (volume matched to vosaroxin) on Days 1 and 4; cytarabine 1 g/m2 daily on Days 1 through 5
Overall Number of Participants Analyzed 355 350
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of Participants
19.7
(15.7 to 24.2)
19.4
(15.4 to 24.0)
5.Other Pre-specified Outcome
Title Overall Remission (OR) Rate Based on the IWG Response Criteria
Hide Description

Group A patient OR compared to Group B patient OR

Overall Remission includes Complete Remission (CR), Complete Remission with incomplete platelet recovery (CRp), Complete Remission with incomplete blood count recovery (CRi), and Partial Remission (PR). Complete remission means bone marrow blast count of less than 5% with adequate recovery of peripheral blood counts as typically defined by the IWG. Both CRi and CRp refer complete remission but with incomplete blood count and platelet recovery, respectively. PR, or partial remission, refers to remission in which bone marrow contains blast counts between 5 and 25 percent.

Time Frame Up to 5 years or the duration of the study
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat Population
Arm/Group Title Group A (Vosaroxin/Cytarabine) Group B (Placebo/Cytarabine)
Hide Arm/Group Description:
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
Placebo (volume matched to vosaroxin) on Days 1 and 4; cytarabine 1 g/m2 daily on Days 1 through 5
Overall Number of Participants Analyzed 356 355
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
37.9
(32.9 to 43.2)
18.9
(14.9 to 23.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group A (Vosaroxin/Cytarabine), Group B (Placebo/Cytarabine)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Two sided P-Value
Method Chi-squared
Comments [Not Specified]
6.Other Pre-specified Outcome
Title Event Free Survival (EFS)
Hide Description [Not Specified]
Time Frame Up to 5 years or duration of study
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat Population
Arm/Group Title Group A (Vosaroxin/Cytarabine) Group B (Placebo/Cytarabine)
Hide Arm/Group Description:
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
Placebo (volume matched to vosaroxin) on Days 1 and 4; cytarabine 1 g/m2 daily on Days 1 through 5
Overall Number of Participants Analyzed 356 355
Median (95% Confidence Interval)
Unit of Measure: months
1.9
(1.6 to 2.2)
1.3
(1.2 to 1.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group A (Vosaroxin/Cytarabine), Group B (Placebo/Cytarabine)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Unstratified one-sided P-Value
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.67
Estimation Comments [Not Specified]
7.Other Pre-specified Outcome
Title Leukemia-Free Survival (LFS)
Hide Description Durability of remission (CR) assessed by LFS
Time Frame Up to 5 years or the duration of the study
Hide Outcome Measure Data
Hide Analysis Population Description
Subset of Intent to Treat patients that have a Measured CR
Arm/Group Title Group A (Vosaroxin/Cytarabine) Group B (Placebo/Cytarabine)
Hide Arm/Group Description:
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
Placebo (volume matched to vosaroxin) on Days 1 and 4; cytarabine 1 g/m2 daily on Days 1 through 5
Overall Number of Participants Analyzed 107 58
Median (95% Confidence Interval)
Unit of Measure: Months
11
(8.3 to 14.3)
8.7
(6.5 to 18.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group A (Vosaroxin/Cytarabine), Group B (Placebo/Cytarabine)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3134
Comments One sided P-Value
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.89
Estimation Comments [Not Specified]
Time Frame Adverse Event reported below reflects time from first patient randomization 17 December 2010 to database lock for primary analysis 26 September 2014. The Tables show Incidence of Treatment Emergent Adverse Events.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Group A (Vosaroxin/Cytarabine) Group B (Placebo/Cytarabine)
Hide Arm/Group Description 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 Placebo (volume matched to vosaroxin) on Days 1 and 4; cytarabine 1 g/m2 daily on Days 1 through 5
All-Cause Mortality
Group A (Vosaroxin/Cytarabine) Group B (Placebo/Cytarabine)
Affected / at Risk (%) Affected / at Risk (%)
Total   273/355 (76.90%)   288/350 (82.29%) 
Hide Serious Adverse Events
Group A (Vosaroxin/Cytarabine) Group B (Placebo/Cytarabine)
Affected / at Risk (%) Affected / at Risk (%)
Total   197/355 (55.49%)   125/350 (35.71%) 
Blood and lymphatic system disorders     
Anaemia * 1  0/355 (0.00%)  2/350 (0.57%) 
Disseminated intravascular coagulation * 1  1/355 (0.28%)  0/350 (0.00%) 
Febrile neutropenia * 1  40/355 (11.27%)  26/350 (7.43%) 
Neutropenia * 1  0/355 (0.00%)  1/350 (0.29%) 
Pancytopenia * 1  2/355 (0.56%)  0/350 (0.00%) 
Pure white cell aplasia * 1  1/355 (0.28%)  0/350 (0.00%) 
Thrombocytopenia * 1  1/355 (0.28%)  1/350 (0.29%) 
Cardiac disorders     
Atrial fibrillation * 1  2/355 (0.56%)  1/350 (0.29%) 
Atrial flutter * 1  1/355 (0.28%)  1/350 (0.29%) 
Cardiac failure congestive * 1  0/355 (0.00%)  1/350 (0.29%) 
Cardiomyopathy * 1  0/355 (0.00%)  1/350 (0.29%) 
Diastolic dysfunction * 1  1/355 (0.28%)  0/350 (0.00%) 
Left ventricular dysfunction * 1  1/355 (0.28%)  0/350 (0.00%) 
Myocardial infarction * 1  1/355 (0.28%)  0/350 (0.00%) 
Myocardial ischaemia * 1  1/355 (0.28%)  0/350 (0.00%) 
Myopericarditis * 1  0/355 (0.00%)  1/350 (0.29%) 
Tachycardia * 1  0/355 (0.00%)  1/350 (0.29%) 
Endocrine disorders     
Diabetes insipidus * 1  1/355 (0.28%)  0/350 (0.00%) 
Eye disorders     
Conjunctivitis * 1  0/355 (0.00%)  1/350 (0.29%) 
Vitreous haemorrhage * 1  1/355 (0.28%)  0/350 (0.00%) 
Gastrointestinal disorders     
Anal fistula * 1  1/355 (0.28%)  0/350 (0.00%) 
Caecitis * 1  1/355 (0.28%)  0/350 (0.00%) 
Colitis * 1  5/355 (1.41%)  0/350 (0.00%) 
Diarrhoea * 1  1/355 (0.28%)  1/350 (0.29%) 
Enteritis * 1  2/355 (0.56%)  0/350 (0.00%) 
Enterocolitis * 1  1/355 (0.28%)  0/350 (0.00%) 
Gastric ulcer perforation * 1  0/355 (0.00%)  1/350 (0.29%) 
Gastritis * 1  1/355 (0.28%)  0/350 (0.00%) 
Gastrointestinal haemorrhage * 1  2/355 (0.56%)  1/350 (0.29%) 
Gastrointestinal inflammation * 1  1/355 (0.28%)  0/350 (0.00%) 
Haemorrhoidal haemorrhage * 1  1/355 (0.28%)  1/350 (0.29%) 
Haemorrhoids * 1  0/355 (0.00%)  2/350 (0.57%) 
Ileitis * 1  0/355 (0.00%)  1/350 (0.29%) 
Ileus * 1  1/355 (0.28%)  1/350 (0.29%) 
Nausea * 1  1/355 (0.28%)  1/350 (0.29%) 
Neutropenic colitis * 1  1/355 (0.28%)  1/350 (0.29%) 
Oesophagitis * 1  3/355 (0.85%)  0/350 (0.00%) 
Periodontitis * 1  0/355 (0.00%)  1/350 (0.29%) 
Stomatitis * 1  12/355 (3.38%)  5/350 (1.43%) 
General disorders     
Asthenia * 1  1/355 (0.28%)  0/350 (0.00%) 
Infusion site extravasation * 1  0/355 (0.00%)  1/350 (0.29%) 
Medical device complication * 1  0/355 (0.00%)  1/350 (0.29%) 
Multi-organ failure * 1  1/355 (0.28%)  0/350 (0.00%) 
Non-cardiac chest pain * 1  1/355 (0.28%)  0/350 (0.00%) 
Pain * 1  1/355 (0.28%)  0/350 (0.00%) 
Pyrexia * 1  3/355 (0.85%)  3/350 (0.86%) 
Sudden death * 1  1/355 (0.28%)  0/350 (0.00%) 
Hepatobiliary disorders     
Biliary colic * 1  1/355 (0.28%)  0/350 (0.00%) 
Cholecystitis * 1  1/355 (0.28%)  0/350 (0.00%) 
Cholestasis * 1  1/355 (0.28%)  1/350 (0.29%) 
Cytolytic hepatitis * 1  1/355 (0.28%)  2/350 (0.57%) 
Hepatic function abnormal * 1  1/355 (0.28%)  0/350 (0.00%) 
Infections and infestations     
Abscess neck * 1  0/355 (0.00%)  1/350 (0.29%) 
Anal abscess * 1  1/355 (0.28%)  2/350 (0.57%) 
Anorectal cellulitis * 1  1/355 (0.28%)  0/350 (0.00%) 
Appendicitis perforated * 1  0/355 (0.00%)  1/350 (0.29%) 
Aspergilloma * 1  1/355 (0.28%)  0/350 (0.00%) 
Aspergillosis * 1  2/355 (0.56%)  1/350 (0.29%) 
Bacteraemia * 1  30/355 (8.45%)  10/350 (2.86%) 
Bronchiolitis * 1  1/355 (0.28%)  0/350 (0.00%) 
Bronchopneumonia * 1  1/355 (0.28%)  1/350 (0.29%) 
Bronchopulmonary aspergillosis * 1  2/355 (0.56%)  1/350 (0.29%) 
Cellulitis * 1  4/355 (1.13%)  1/350 (0.29%) 
Clostridial infection * 1  1/355 (0.28%)  1/350 (0.29%) 
Clostridium difficile colitis * 1  0/355 (0.00%)  1/350 (0.29%) 
Device related infection * 1  1/355 (0.28%)  0/350 (0.00%) 
Device related sepsis * 1  0/355 (0.00%)  1/350 (0.29%) 
Diverticulitis * 1  0/355 (0.00%)  1/350 (0.29%) 
Enterobacter infection * 1  1/355 (0.28%)  0/350 (0.00%) 
Enterobacter sepsis * 1  1/355 (0.28%)  0/350 (0.00%) 
Enterococcal infection * 1  1/355 (0.28%)  0/350 (0.00%) 
Enterococcal sepsis * 1  2/355 (0.56%)  0/350 (0.00%) 
Enterocolitis bacterial * 1  1/355 (0.28%)  0/350 (0.00%) 
Enterocolitis infectious * 1  1/355 (0.28%)  0/350 (0.00%) 
Escherichia bacteraemia * 1  1/355 (0.28%)  1/350 (0.29%) 
Escherichia sepsis * 1  1/355 (0.28%)  1/350 (0.29%) 
Folliculitis * 1  0/355 (0.00%)  1/350 (0.29%) 
Fungaemia * 1  1/355 (0.28%)  0/350 (0.00%) 
Fungal infection * 1  2/355 (0.56%)  2/350 (0.57%) 
Fungal sepsis * 1  1/355 (0.28%)  0/350 (0.00%) 
Gastroenteritis * 1  1/355 (0.28%)  0/350 (0.00%) 
Gastrointestinal infection * 1  1/355 (0.28%)  0/350 (0.00%) 
Infection * 1  1/355 (0.28%)  0/350 (0.00%) 
Infusion site cellulitis * 1  1/355 (0.28%)  0/350 (0.00%) 
Klebsiella bacteraemia * 1  0/355 (0.00%)  1/350 (0.29%) 
Klebsiella infection * 1  1/355 (0.28%)  0/350 (0.00%) 
Klebsiella sepsis * 1  1/355 (0.28%)  1/350 (0.29%) 
Localised infection * 1  0/355 (0.00%)  1/350 (0.29%) 
Lower respiratory tract infection * 1  0/355 (0.00%)  1/350 (0.29%) 
Neutropenic sepsis * 1  9/355 (2.54%)  7/350 (2.00%) 
Perirectal abscess * 1  3/355 (0.85%)  0/350 (0.00%) 
Pharyngitis * 1  0/355 (0.00%)  1/350 (0.29%) 
Pneumonia * 1  27/355 (7.61%)  17/350 (4.86%) 
Pneumonia fungal * 1  7/355 (1.97%)  2/350 (0.57%) 
Pneumonia staphylococcal * 1  1/355 (0.28%)  0/350 (0.00%) 
Pseudomonal sepsis * 1  1/355 (0.28%)  1/350 (0.29%) 
Pseudomonas infection * 1  1/355 (0.28%)  2/350 (0.57%) 
Pulmonary mycosis * 1  1/355 (0.28%)  0/350 (0.00%) 
Pulmonary sepsis * 1  2/355 (0.56%)  0/350 (0.00%) 
Pulmonary tuberculosis * 1  1/355 (0.28%)  0/350 (0.00%) 
Respiratory syncytial virus infection * 1  0/355 (0.00%)  1/350 (0.29%) 
Sepsis * 1  31/355 (8.73%)  15/350 (4.29%) 
Septic embolus * 1  1/355 (0.28%)  0/350 (0.00%) 
Septic shock * 1  7/355 (1.97%)  6/350 (1.71%) 
Sinusitis * 1  0/355 (0.00%)  1/350 (0.29%) 
Sinusitis aspergillus * 1  0/355 (0.00%)  1/350 (0.29%) 
Sinusitis fungal * 1  1/355 (0.28%)  0/350 (0.00%) 
Staphylococcal bacteraemia * 1  1/355 (0.28%)  2/350 (0.57%) 
Staphylococcal infection * 1  4/355 (1.13%)  1/350 (0.29%) 
Streptococcal bacteraemia * 1  3/355 (0.85%)  0/350 (0.00%) 
Systemic candida * 1  1/355 (0.28%)  2/350 (0.57%) 
Thrombophlebitis septic * 1  1/355 (0.28%)  0/350 (0.00%) 
Tooth abscess * 1  0/355 (0.00%)  4/350 (1.14%) 
Urinary tract infection * 1  0/355 (0.00%)  4/350 (1.14%) 
Urinary tract infection enterococcal * 1  1/355 (0.28%)  1/350 (0.29%) 
Urosepsis * 1  1/355 (0.28%)  0/350 (0.00%) 
Viral pericarditis * 1  1/355 (0.28%)  0/350 (0.00%) 
Vulval abscess * 1  1/355 (0.28%)  0/350 (0.00%) 
Vulval cellulitis * 1  0/355 (0.00%)  1/350 (0.29%) 
Vulvovaginitis * 1  1/355 (0.28%)  0/350 (0.00%) 
Injury, poisoning and procedural complications     
Fall * 1  1/355 (0.28%)  1/350 (0.29%) 
Febrile nonhaemolytic transfusion reaction * 1  1/355 (0.28%)  0/350 (0.00%) 
Foot fracture * 1  1/355 (0.28%)  0/350 (0.00%) 
Subdural haematoma * 1  0/355 (0.00%)  2/350 (0.57%) 
Transfusion reaction * 1  1/355 (0.28%)  0/350 (0.00%) 
Investigations     
Blood pressure increased * 1  1/355 (0.28%)  0/350 (0.00%) 
Hepatic enzyme increased * 1  1/355 (0.28%)  0/350 (0.00%) 
Lipase increased * 1  1/355 (0.28%)  0/350 (0.00%) 
Transaminases increased * 1  0/355 (0.00%)  1/350 (0.29%) 
Metabolism and nutrition disorders     
Dehydration * 1  2/355 (0.56%)  0/350 (0.00%) 
Diabetic ketoacidosis * 1  0/355 (0.00%)  1/350 (0.29%) 
Failure to thrive * 1  1/355 (0.28%)  1/350 (0.29%) 
Hypernatraemia * 1  1/355 (0.28%)  0/350 (0.00%) 
Hyponatraemia * 1  0/355 (0.00%)  1/350 (0.29%) 
Nervous system disorders     
Coma * 1  1/355 (0.28%)  0/350 (0.00%) 
Haemorrhage intracranial * 1  0/355 (0.00%)  1/350 (0.29%) 
Headache * 1  0/355 (0.00%)  1/350 (0.29%) 
Intracranial pressure increased * 1  1/355 (0.28%)  0/350 (0.00%) 
Ischaemic cerebral infarction * 1  0/355 (0.00%)  1/350 (0.29%) 
Ischaemic stroke * 1  0/355 (0.00%)  2/350 (0.57%) 
Neurotoxicity * 1  0/355 (0.00%)  1/350 (0.29%) 
Presyncope * 1  2/355 (0.56%)  0/350 (0.00%) 
Subarachnoid haemorrhage * 1  1/355 (0.28%)  0/350 (0.00%) 
Psychiatric disorders     
Confusional state * 1  0/355 (0.00%)  2/350 (0.57%) 
Renal and urinary disorders     
Acute prerenal failure * 1  1/355 (0.28%)  0/350 (0.00%) 
Haematuria * 1  1/355 (0.28%)  0/350 (0.00%) 
Nephrolithiasis * 1  1/355 (0.28%)  0/350 (0.00%) 
Renal failure * 1  1/355 (0.28%)  0/350 (0.00%) 
Renal failure acute * 1  1/355 (0.28%)  0/350 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Acute respiratory distress syndrome * 1  0/355 (0.00%)  1/350 (0.29%) 
Epistaxis * 1  0/355 (0.00%)  4/350 (1.14%) 
Haemothorax * 1  1/355 (0.28%)  1/350 (0.29%) 
Lung disorder * 1  1/355 (0.28%)  0/350 (0.00%) 
Lung infiltration * 1  0/355 (0.00%)  1/350 (0.29%) 
Pleural effusion * 1  1/355 (0.28%)  0/350 (0.00%) 
Pneumonitis * 1  2/355 (0.56%)  0/350 (0.00%) 
Pneumothorax * 1  1/355 (0.28%)  0/350 (0.00%) 
Pulmonary haemorrhage * 1  2/355 (0.56%)  0/350 (0.00%) 
Pulmonary oedema * 1  1/355 (0.28%)  0/350 (0.00%) 
Respiratory failure * 1  2/355 (0.56%)  0/350 (0.00%) 
Skin and subcutaneous tissue disorders     
Angioedema * 1  1/355 (0.28%)  0/350 (0.00%) 
Skin nodule * 1  0/355 (0.00%)  1/350 (0.29%) 
Vascular disorders     
Deep vein thrombosis * 1  0/355 (0.00%)  1/350 (0.29%) 
Embolism arterial * 1  1/355 (0.28%)  0/350 (0.00%) 
Hypotension * 1  1/355 (0.28%)  0/350 (0.00%) 
Hypovolaemic shock * 1  1/355 (0.28%)  0/350 (0.00%) 
Shock * 1  2/355 (0.56%)  0/350 (0.00%) 
Vena cava thrombosis * 1  1/355 (0.28%)  0/350 (0.00%) 
Venous thrombosis * 1  0/355 (0.00%)  1/350 (0.29%) 
1
Term from vocabulary, MedDRA (13.1)
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Group A (Vosaroxin/Cytarabine) Group B (Placebo/Cytarabine)
Affected / at Risk (%) Affected / at Risk (%)
Total   354/355 (99.72%)   349/350 (99.71%) 
Blood and lymphatic system disorders     
Anaemia * 1  95/355 (26.76%)  104/350 (29.71%) 
Febrile neutropenia * 1  143/355 (40.28%)  97/350 (27.71%) 
Neutropenia * 1  70/355 (19.72%)  50/350 (14.29%) 
Thrombocytopenia * 1  88/355 (24.79%)  90/350 (25.71%) 
Cardiac disorders     
Atrial fibrillation * 1  22/355 (6.20%)  16/350 (4.57%) 
Tachycardia * 1  32/355 (9.01%)  29/350 (8.29%) 
Gastrointestinal disorders     
Abdominal distension * 1  20/355 (5.63%)  10/350 (2.86%) 
Abdominal pain * 1  79/355 (22.25%)  46/350 (13.14%) 
Abdominal pain upper * 1  31/355 (8.73%)  33/350 (9.43%) 
Constipation * 1  136/355 (38.31%)  141/350 (40.29%) 
Diarrhoea * 1  243/355 (68.45%)  121/350 (34.57%) 
Dry mouth * 1  22/355 (6.20%)  12/350 (3.43%) 
Dyspepsia * 1  46/355 (12.96%)  17/350 (4.86%) 
Dysphagia * 1  20/355 (5.63%)  7/350 (2.00%) 
Haemorrhoids * 1  30/355 (8.45%)  14/350 (4.00%) 
Nausea * 1  218/355 (61.41%)  167/350 (47.71%) 
Oral pain * 1  21/355 (5.92%)  6/350 (1.71%) 
Stomatitis * 1  169/355 (47.61%)  64/350 (18.29%) 
Vomiting * 1  135/355 (38.03%)  73/350 (20.86%) 
General disorders     
Asthenia * 1  60/355 (16.90%)  43/350 (12.29%) 
Chest pain * 1  29/355 (8.17%)  19/350 (5.43%) 
Chills * 1  61/355 (17.18%)  46/350 (13.14%) 
Fatigue * 1  107/355 (30.14%)  94/350 (26.86%) 
Oedema peripheral * 1  96/355 (27.04%)  69/350 (19.71%) 
Pain * 1  21/355 (5.92%)  32/350 (9.14%) 
Pyrexia * 1  118/355 (33.24%)  106/350 (30.29%) 
Infections and infestations     
Bacteraemia * 1  18/355 (5.07%)  6/350 (1.71%) 
Oral candidiasis * 1  18/355 (5.07%)  16/350 (4.57%) 
Oral herpes * 1  23/355 (6.48%)  4/350 (1.14%) 
Pneumonia * 1  22/355 (6.20%)  19/350 (5.43%) 
Injury, poisoning and procedural complications     
Procedural pain * 1  8/355 (2.25%)  20/350 (5.71%) 
Transfusion reaction * 1  18/355 (5.07%)  16/350 (4.57%) 
Investigations     
Alanine aminotransferase increased * 1  29/355 (8.17%)  17/350 (4.86%) 
Aspartate aminotransferase increased * 1  24/355 (6.76%)  16/350 (4.57%) 
Blood creatinine increased * 1  18/355 (5.07%)  10/350 (2.86%) 
Platelet count decreased * 1  23/355 (6.48%)  29/350 (8.29%) 
White blood cell count decreased * 1  24/355 (6.76%)  21/350 (6.00%) 
Metabolism and nutrition disorders     
Decreased appetite * 1  126/355 (35.49%)  59/350 (16.86%) 
Fluid overload * 1  18/355 (5.07%)  16/350 (4.57%) 
Fluid retention * 1  19/355 (5.35%)  23/350 (6.57%) 
Hyperglycaemia * 1  43/355 (12.11%)  33/350 (9.43%) 
Hypoalbuminaemia * 1  30/355 (8.45%)  20/350 (5.71%) 
Hypocalcaemia * 1  49/355 (13.80%)  25/350 (7.14%) 
Hypokalaemia * 1  170/355 (47.89%)  102/350 (29.14%) 
Hypomagnesaemia * 1  95/355 (26.76%)  58/350 (16.57%) 
Hyponatraemia * 1  31/355 (8.73%)  20/350 (5.71%) 
Hypophosphataemia * 1  56/355 (15.77%)  26/350 (7.43%) 
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  24/355 (6.76%)  27/350 (7.71%) 
Back pain * 1  35/355 (9.86%)  38/350 (10.86%) 
Bone pain * 1  21/355 (5.92%)  18/350 (5.14%) 
Musculoskeletal pain * 1  16/355 (4.51%)  22/350 (6.29%) 
Pain in extremity * 1  34/355 (9.58%)  44/350 (12.57%) 
Nervous system disorders     
Dizziness * 1  32/355 (9.01%)  35/350 (10.00%) 
Dysgeusia * 1  25/355 (7.04%)  7/350 (2.00%) 
Headache * 1  103/355 (29.01%)  93/350 (26.57%) 
Psychiatric disorders     
Anxiety * 1  43/355 (12.11%)  56/350 (16.00%) 
Confusional state * 1  25/355 (7.04%)  19/350 (5.43%) 
Depression * 1  30/355 (8.45%)  22/350 (6.29%) 
Insomnia * 1  78/355 (21.97%)  70/350 (20.00%) 
Respiratory, thoracic and mediastinal disorders     
Cough * 1  71/355 (20.00%)  44/350 (12.57%) 
Dyspnoea * 1  63/355 (17.75%)  44/350 (12.57%) 
Epistaxis * 1  56/355 (15.77%)  55/350 (15.71%) 
Hiccups * 1  23/355 (6.48%)  8/350 (2.29%) 
Oropharyngeal pain * 1  46/355 (12.96%)  41/350 (11.71%) 
Pleural effusion * 1  26/355 (7.32%)  12/350 (3.43%) 
Skin and subcutaneous tissue disorders     
Alopecia * 1  28/355 (7.89%)  9/350 (2.57%) 
Erythema * 1  25/355 (7.04%)  16/350 (4.57%) 
Petechiae * 1  27/355 (7.61%)  23/350 (6.57%) 
Pruritus * 1  41/355 (11.55%)  28/350 (8.00%) 
Rash * 1  53/355 (14.93%)  37/350 (10.57%) 
Rash maculo-papular * 1  21/355 (5.92%)  10/350 (2.86%) 
Vascular disorders     
Hypertension * 1  40/355 (11.27%)  32/350 (9.14%) 
Hypotension * 1  66/355 (18.59%)  50/350 (14.29%) 
1
Term from vocabulary, MedDRA (13.1)
*
Indicates events were collected by non-systematic assessment
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Judy Fox, Chief Scientific Officer
Organization: Sunesis Pharmaceuticals, Inc
Phone: (650) 266-3736
EMail: jfox@sunesis.com
Layout table for additonal information
Responsible Party: Sunesis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01191801    
Other Study ID Numbers: VOS-AML-301
2010-021961-61 ( EudraCT Number )
First Submitted: August 27, 2010
First Posted: August 31, 2010
Results First Submitted: April 12, 2016
Results First Posted: May 9, 2017
Last Update Posted: August 22, 2018