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Anti-metabolite

Vosaroxin + Azacitidine for Myelodysplastic Syndrome

Phase 1
Waitlist Available
Led By Meagan Jacoby, M.D., Ph.D.
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
serum creatinine within normal institutional limits or estimated creatinine clearance ≥60 mL/min/1.73 m2 by the Cockcroft-Gault equation
Cytopenias requiring red blood cell and/or platelet transfusions or neutropenia (ANC <1 X109/L)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study Summary

This trial is testing vosaroxin + azacitidine to treat MDS. Vosaroxin + azacitidine kill cancer cells or stop them from dividing.

Who is the study for?
Adults over 18 with Myelodysplastic Syndromes or certain types of preleukemia, who may have had up to three prior treatments with hypomethylator therapy. Participants need proper liver and kidney function, not be pregnant or breastfeeding, and willing to use contraception. Excludes those with HIV/HBV/HCV infections, severe illnesses that affect study compliance, or extensive prior treatment.Check my eligibility
What is being tested?
The trial is testing the combination of two chemotherapy drugs: vosaroxin and azacitidine. It aims to find the safest doses for patients with Myelodysplastic Syndromes by observing how these drugs stop cancer cells from growing either by killing them or preventing their division.See study design
What are the potential side effects?
Potential side effects include typical chemotherapy-related issues such as nausea, fatigue, hair loss, increased risk of infection due to low blood cell counts, organ inflammation, and possible allergic reactions among others.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My kidney function, measured by creatinine levels or clearance, is within the normal range.
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I need blood or platelet transfusions due to low blood counts.
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I can take care of myself but might not be able to do heavy physical work.
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I am using or will use birth control during and for 30 days after the study.
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I have myelodysplastic syndrome with specific blood or bone marrow conditions.
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I am 18 years old or older.
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My liver and kidney functions are within normal ranges.
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I am part of, or agree to join, a study collecting blood, bone marrow, and skin samples.
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I am 18 years old or older.
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I can take care of myself but might not be able to do heavy physical work.
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My condition is either MDS with 20-29% bone marrow blasts or chronic myelomonocytic leukemia.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
MTD of vosaroxin in combination with azacitidine
Secondary outcome measures
Best overall response
Best response (including hematologic improvement)
Biomarkers of response to vosaroxin and azacitidine therapy
+6 more

Side effects data

From 2009 Phase 2 trial • 113 Patients • NCT00607997
83%
Diarrhoea
76%
Nausea
72%
Anorexia
72%
Hypokalaemia
62%
Stomatitis
59%
Oedema peripheral
55%
Vomiting
52%
Hypomagnesaemia
52%
Fatigue
45%
Cough
45%
Hypophosphataemia
41%
Constipation
41%
Neutropenia
41%
Thrombocytopenia
41%
Insomnia
41%
Anaemia
41%
Alopecia
38%
Tachycardia
38%
Dyspnoea
38%
Hypotension
34%
Headache
34%
Febrile neutropenia
34%
Rales
31%
Abdominal pain
31%
Asthenia
28%
Hypocalcaemia
28%
Petechiae
28%
Chills
28%
Confusional state
28%
Ecchymosis
24%
Epistaxis
24%
Pleural effusion
24%
Rash
24%
Breath sounds abnormal
24%
Dehydration
24%
Anxiety
21%
Dry mouth
21%
Weight decreased
21%
Malaise
21%
Dizziness
21%
Hypertension
21%
Agitation
17%
Dyspepsia
17%
Haemorrhoids
17%
Pain
17%
Pneumonia
17%
Back pain
17%
Pruritus
17%
Dysphagia
17%
Depression
17%
Pyrexia
14%
Atrial fibrillation
14%
Muscular weakness
14%
Musculoskeletal pain
14%
Dysgeusia
14%
Somnolence
14%
Pallor
14%
Hyperhidrosis
14%
International normalised ratio increased
14%
Pain in extremity
14%
Haematuria
14%
Odynophagia
10%
Vision blurred
10%
Gastrointestinal haemorrhage
10%
Staphylococcal bacteraemia
10%
Fall
10%
Skin laceration
10%
Blood creatinine increased
10%
Hyperglycaemia
10%
Myalgia
10%
Dysuria
10%
Urinary incontinence
10%
Haemoptysis
10%
Hypoxia
10%
Pulmonary oedema
10%
Rhonchi
10%
Sinus congestion
10%
Dry skin
10%
Chest pain
10%
Candidiasis
10%
Lip dry
10%
Enterococcal bacteraemia
10%
Contusion
10%
Malnutrition
10%
Restlessness
10%
Productive cough
10%
Rash erythematous
10%
Skin lesion
10%
Transfusion reaction
7%
Bacteraemia
7%
Wheezing
7%
Pseudomonal sepsis
7%
Renal failure acute
7%
Leukopenia
7%
Abdominal distension
7%
Breath odour
7%
Diverticulum
7%
Oral mucosal petechiae
7%
Oral pain
7%
Tongue haematoma
7%
Catheter related complication
7%
Oedema
7%
Cellulitis
7%
Enterococcal infection
7%
Herpes simplex
7%
Urinary tract infection
7%
Urinary tract infection enterococcal
7%
Fluid overload
7%
Hyperphosphataemia
7%
Musculoskeletal chest pain
7%
Dysarthria
7%
Hallucination
7%
Hiccups
7%
Lung disorder
7%
Pharyngolaryngeal pain
7%
Pleuritic pain
7%
Respiratory distress
7%
Night sweats
7%
Rash maculo-papular
7%
Diverticulitis
7%
Cardiac failure congestive
7%
Incontinence
7%
Salivary hypersecretion
7%
Wound
7%
Ejection fraction decreased
7%
Haematoma
7%
Hyponatraemia
7%
Arthralgia
7%
Delirium
7%
Pollakiuria
7%
Urinary retention
7%
Atelectasis
7%
Lung infiltration
7%
Blister
7%
Erythema
7%
Ear pain
7%
Rash macular
3%
Flushing
3%
Neutropenic colitis
3%
Deep vein thrombosis
3%
Oesophagitis
3%
Oesophageal stenosis
3%
Catheter site oedema
3%
Oral intake reduced
3%
Hyperkalaemia
3%
Rhinitis
3%
Proctalgia
3%
Catheter site inflammation
3%
Skin infection
3%
Nocturia
3%
Abscess
3%
Body temperature decreased
3%
Prothrombin time prolonged
3%
Myocardial ischaemia
3%
Intestinal functional disorder
3%
Hyperbilirubinaemia
3%
Cellulitis orbital
3%
Pneumonia fungal
3%
Sepsis
3%
Staphylococcal infection
3%
Staphylococcal sepsis
3%
Streptococcal bacteraemia
3%
Myositis
3%
Suicidal ideation
3%
Renal failure
3%
Acute respiratory failure
3%
Hilar lymphadenopathy
3%
Microcytic anaemia
3%
Bradycardia
3%
Bundle branch block left
3%
Mitral valve incompetence
3%
Myocardial infraction
3%
Sinus bradycardia
3%
Sinus Tachycardia
3%
Ventricular extrasystoles
3%
Eustachian tube patulous
3%
Tinnitus
3%
Erythema of eyelid
3%
Madarosis
3%
Ocular icterus
3%
Visual disturbance
3%
Abdominal pain lower
3%
Abdominal pain upper
3%
Anorectal disorder
3%
Caecitis
3%
Enlarged uvula
3%
Faecal incontinence
3%
Gastritis
3%
Gingivitis
3%
Haemorrhoidal haemorrhage
3%
Leukoplakia oral
3%
Lip pain
3%
Mouth ulceration
3%
Oral soft tissue disorder
3%
Palatal disorder
3%
Tongue blistering
3%
Tongue discolouration
3%
Toothache
3%
Application site hypersensitivity
3%
Feeling cold
3%
Generalized oedema
3%
Injection site bruising
3%
Injection site reaction
3%
Mucosal Inflammation
3%
Nodule
3%
Non-Cardiac chest pain
3%
Cholelithiasis
3%
Bacterial infection
3%
Bronchiolitis
3%
Catheter site infection
3%
Clostridium difficile colitis
3%
Fungaemia
3%
Fusarium infection
3%
Lobar pneumonia
3%
Pseudomonas infection
3%
Upper respiratory tract infection
3%
Urinary tract infection staphylococcal
3%
Bacteria urine identified
3%
Blood alkaline phosphatase increased
3%
Blood urea increased
3%
Chest x-ray abnormal
3%
Electrocardiogram st segment depression
3%
Electrocardiogram st-t change
3%
Electrocardiogram t wave inversion
3%
Helicobacter pylori identification test positive
3%
Prothrombin level increased
3%
Hypoalbuminaemia
3%
Arthritis
3%
Bone pain
3%
Musculoskeletal stiffness
3%
Lung neoplasm
3%
Tumour lysis syndrome
3%
Carotid artery occlusion
3%
Coordination abnormal
3%
Encephalopathy
3%
Hypoaesthesia
3%
Hypogeusia
3%
Lethargy
3%
Neuropathy peripheral
3%
Restless legs syndrome
3%
Transient ischaemic attack
3%
Mental disorder
3%
Renal mass
3%
Residual urine
3%
Vulval disorder
3%
Acute respiratory distress syndrome
3%
Diaphragmalgia
3%
Pharyngeal inflammation
3%
Pulmonary granuloma
3%
Respiratory alkalosis
3%
Dermatitis
3%
Leukoplakia
3%
Nail disorder
3%
Periorbital oedema
3%
Perivascular dermatitis
3%
Purpura
3%
Rash generalised
3%
Coagulopathy
3%
Red man syndrome
3%
Skin Hypopigmentation
3%
Skin reaction
3%
Orthostatic hypotension
3%
Conjunctival haemorrhage
3%
Ocular hyperaemia
3%
Abdominal discomfort
3%
Facial pain
3%
Gait disturbance
3%
Infusion site pain
3%
Vaginal candidiasis
3%
Tooth fracture
3%
Swelling
3%
Cholecystitis
3%
Skin turgor decreased
3%
Jaundice
3%
Acinetobacter bacteraemia
3%
Death
3%
Multi-Organ failure
3%
Neuralgia
3%
Septic shock
3%
Sinusitis
3%
Streptococcal sepsis
3%
Failure to thrive
3%
Grand mal convulsion
3%
Lymph node calcification
3%
Lymphopenia
3%
Arteriosclerosis coronary artery
3%
Pericardial effusion
3%
Deafness bilateral
3%
Ear congestion
3%
Dry eye
3%
Haemorrhage urinary tract
3%
Aptyalism
3%
Ascites
3%
Bowel sounds abnormal
3%
Catheter related infection
3%
Glossodynia
3%
Haematochezia
3%
Malabsorption
3%
Melaena
3%
Oral mucosal discolouration
3%
Perianal erythema
3%
Rectal fissure
3%
Catheter site erythema
3%
Catheter site excoriation
3%
Rhinitis allergic
3%
Catheter site pain
3%
Skin discolouration
3%
Wound complication
3%
Blood glucose increased
3%
Blood testosterone decreased
3%
C-Reactive protein increased
3%
Transaminases increased
3%
White blood cell count decreased
3%
Diabetes mellitus
3%
Diabetes mellitus insulin-dependent
3%
Groin pain
3%
Osteosclerosis
3%
Tremor
3%
Renal cyst
3%
Vulvovaginal pruritus
3%
Dyspnoea exertional
3%
Nasal dryness
3%
Obstructive airways disorder
3%
Respiratory failure
3%
Upper respiratory tract congestion
3%
Acne
3%
Decubitus ulcer
3%
Palmar-plantar erythrodysaesthesia syndrome
3%
Skin disorder
3%
Skin exfoliation
3%
Skin ulcer
3%
Urticaria
3%
Sinus operation
3%
Angina pectoris
3%
Folliculitis
3%
Disseminated Intravascular Coagulation
3%
Cardiomegaly
3%
Chapped lips
3%
Catheter site haemorrhage
3%
Heart rate irregular
3%
Lymph node palpable
3%
Hypernatraemia
3%
Hyperuricaemia
3%
Pigmentation disorder
3%
Rash pruritic
100%
80%
60%
40%
20%
0%
Study treatment Arm
Schedule A: 72 mg/m2 Vosaroxin Days 1, 8 and 15
Schedule B: 72 mg/m2 Vosaroxin on Days 1 and 8
Schedule C: 72 mg/m2 on Days 1 and 4
Schedule C: 90 mg/m2 on Days 1 and 4

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (vosaroxin, azacitidine)Experimental Treatment2 Interventions
Patients receive vosaroxin IV over 10 minutes on days 1 and 4 and azacitidine SC or IV over 15 minutes on days 1-7. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
vosaroxin
2008
Completed Phase 2
~120
Azacitidine
2012
Completed Phase 3
~1440

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor
1,926 Previous Clinical Trials
2,296,847 Total Patients Enrolled
Sunesis PharmaceuticalsIndustry Sponsor
16 Previous Clinical Trials
1,480 Total Patients Enrolled
Meagan Jacoby, M.D., Ph.D.Principal InvestigatorWashington University School of Medicine
5 Previous Clinical Trials
571 Total Patients Enrolled

Media Library

Azacitidine (Anti-metabolite) Clinical Trial Eligibility Overview. Trial Name: NCT01913951 — Phase 1
Myelodysplastic Syndrome Research Study Groups: Treatment (vosaroxin, azacitidine)
Myelodysplastic Syndrome Clinical Trial 2023: Azacitidine Highlights & Side Effects. Trial Name: NCT01913951 — Phase 1
Azacitidine (Anti-metabolite) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01913951 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the primary purpose of vosaroxin?

"Vosaroxin is most often used to treat patients with malignant neoplasms. It can also be useful in treating 20-30% blasts, neutropenia and/or thrombocytopenia, and anemia."

Answered by AI

Is this the first time vosaroxin has been looked at in a scientific setting?

"There are presently 181 active trials for vosaroxin in progress, 34 of which have reached Phase 3. Some studies related to vosaroxin are wrapping up in Saint Louis, Missouri; however, there are 5769 other locations conducting research on this medication."

Answered by AI

To what degree does vosaroxin put patients at risk?

"Vosaroxin falls into the Phase 1 category on our Power team's safety scale. That means that there is limited clinical data supporting both its efficacy and safety."

Answered by AI

Are there any open positions left in this clinical trial?

"According to the listing on clinicaltrials.gov, this trial is not actively recruiting patients at this time. This study was originally posted on November 22nd, 2013 and updated as recently as March 23rd, 2022. There are 1853 other studies that are looking for patients right now."

Answered by AI

How many people are being studied in this experiment?

"Unfortunately, this particular clinical trial is not currently looking for new participants. The study was originally posted on November 22nd, 2013 and was last updated on March 23rd, 2022. There are 1672 other studies actively recruiting patients with myelodysplastic syndromes and 181 trials for vosaroxin that are accepting new patients at this time."

Answered by AI
~3 spots leftby Mar 2025