Last reviewed · How we verify
Study of Vosaroxin or Placebo in Combination With Cytarabine in Patients With First Relapsed or Refractory AML
Phase 3 trial testing vosaroxin + cytarabine in Acute Myeloid Leukemia in 711 participants. Completed in 1 March 2017.
| Lead sponsor | Sunesis Pharmaceuticals |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 711 |
| Start date | 17 December 2010 |
| Primary completion | 26 September 2014 |
| Estimated completion | 1 March 2017 |
| Sites | 124 locations across France, Italy, New Zealand, Belgium, Austria, United Kingdom, Germany, Hungary |
Sunesis Pharmaceuticals — full company profile →
18 and older, any sex, with Acute Myeloid Leukemia. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Vosaroxin + cytarabine patient survival versus placebo + cytarabine patient survival
| Group | Value | 95% CI |
|---|---|---|
| Group A (Vosaroxin/Cytarabine) | 7.5 | 6.4 – 8.5 |
| Group B (Placebo/Cytarabine) | 6.1 | 5.2 – 7.1 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Group A (Vosaroxin/Cytarabine) | 30.1 | 25.3 – 35.1 |
| Group B (Placebo/Cytarabine) | 16.3 | 12.6 – 20.6 |
Vosaroxin + cytarabine mortality versus placebo + cytarabine mortality
| Group | Value | 95% CI |
|---|---|---|
| Group A (Vosaroxin/Cytarabine) | 7.9 | 5.3 – 11.2 |
| Group B (Placebo/Cytarabine) | 6.6 | 4.2 – 9.7 |
Vosaroxin + cytarabine mortality versus placebo + cytarabine mortality
| Group | Value | 95% CI |
|---|---|---|
| Group A (Vosaroxin/Cytarabine) | 19.7 | 15.7 – 24.2 |
| Group B (Placebo/Cytarabine) | 19.4 | 15.4 – 24.0 |
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 count
| Group | Value | 95% CI |
|---|---|---|
| Group A (Vosaroxin/Cytarabine) | 37.9 | 32.9 – 43.2 |
| Group B (Placebo/Cytarabine) | 18.9 | 14.9 – 23.3 |
| Group | Value | 95% CI |
|---|---|---|
| Group A (Vosaroxin/Cytarabine) | 1.9 | 1.6 – 2.2 |
| Group B (Placebo/Cytarabine) | 1.3 | 1.2 – 1.4 |
Durability of remission (CR) assessed by LFS
| Group | Value | 95% CI |
|---|---|---|
| Group A (Vosaroxin/Cytarabine) | 11 | 8.3 – 14.3 |
| Group B (Placebo/Cytarabine) | 8.7 | 6.5 – 18.0 |
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.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Group A (Vosaroxin/Cytarab… | Group B (Placebo/Cytarabine) |
|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | — | — |
| Sepsis | Infections and infestations | — | — |
| Bacteraemia | Infections and infestations | — | — |
| Pneumonia | Infections and infestations | — | — |
| Stomatitis | Gastrointestinal disorders | — | — |
| Neutropenic sepsis | Infections and infestations | — | — |
| Pneumonia fungal | Infections and infestations | — | — |
| Septic shock | Infections and infestations | — | — |
| Colitis | Gastrointestinal disorders | — | — |
| Cellulitis | Infections and infestations | — | — |
| Staphylococcal infection | Infections and infestations | — | — |
| Tooth abscess | Infections and infestations | — | — |
| Urinary tract infection | Infections and infestations | — | — |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | — | — |
| Oesophagitis | Gastrointestinal disorders | — | — |
| Pyrexia | General disorders | — | — |
| Perirectal abscess | Infections and infestations | — | — |
| Streptococcal bacteraemia | Infections and infestations | — | — |
| Anaemia | Blood and lymphatic system disorders | — | — |
| Pancytopenia | Blood and lymphatic system disorders | — | — |
| Atrial fibrillation | Cardiac disorders | — | — |
| Enteritis | Gastrointestinal disorders | — | — |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | — | — |
| Haemorrhoids | Gastrointestinal disorders | — | — |
| Cytolytic hepatitis | Hepatobiliary disorders | — | — |
| Reaction | System | Group A (Vosaroxin/Cytarab… | Group B (Placebo/Cytarabine) |
|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | — | — |
| Nausea | Gastrointestinal disorders | — | — |
| Hypokalaemia | Metabolism and nutrition disorders | — | — |
| Stomatitis | Gastrointestinal disorders | — | — |
| Febrile neutropenia | Blood and lymphatic system disorders | — | — |
| Constipation | Gastrointestinal disorders | — | — |
| Vomiting | Gastrointestinal disorders | — | — |
| Decreased appetite | Metabolism and nutrition disorders | — | — |
| Pyrexia | General disorders | — | — |
| Fatigue | General disorders | — | — |
| Anaemia | Blood and lymphatic system disorders | — | — |
| Headache | Nervous system disorders | — | — |
| Oedema peripheral | General disorders | — | — |
| Hypomagnesaemia | Metabolism and nutrition disorders | — | — |
| Thrombocytopenia | Blood and lymphatic system disorders | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — |
| Insomnia | Psychiatric disorders | — | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — | — |
| Neutropenia | Blood and lymphatic system disorders | — | — |
| Hypotension | Vascular disorders | — | — |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | — | — |
| Chills | General disorders | — | — |
| Asthenia | General disorders | — | — |
| Hypophosphataemia | Metabolism and nutrition disorders | — | — |
| Anxiety | Psychiatric disorders | — | — |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | — | — |
| Rash | Skin and subcutaneous tissue disorders | — | — |
| Hypocalcaemia | Metabolism and nutrition disorders | — | — |
| Dyspepsia | Gastrointestinal disorders | — | — |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | — | — |
| Pain in extremity | Musculoskeletal and connective tissue disorders | — | — |
| Hyperglycaemia | Metabolism and nutrition disorders | — | — |
| Pruritus | Skin and subcutaneous tissue disorders | — | — |
| Hypertension | Vascular disorders | — | — |
| Back pain | Musculoskeletal and connective tissue disorders | — | — |
| Dizziness | Nervous system disorders | — | — |
| Abdominal pain upper | Gastrointestinal disorders | — | — |
| Tachycardia | Cardiac disorders | — | — |
| Pain | General disorders | — | — |
| Hyponatraemia | Metabolism and nutrition disorders | — | — |
Most-reported serious reactions: Febrile neutropenia, Sepsis, Bacteraemia, Pneumonia, Stomatitis, Neutropenic sepsis, Pneumonia fungal, Septic shock.
Data from ClinicalTrials.gov NCT01191801 adverse events section.
This study compared treatment groups of patients treated with vosaroxin and cytarabine versus patients treated with placebo and cytarabine.
7 peer-reviewed publications reference this trial (live from Europe PMC):
Verify or expand the search:
Currently open trials in the same condition.
Trials by the same sponsor.
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01191801.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing