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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 belowSelect...
My kidney function, measured by creatinine levels or clearance, is within the normal range.
Select...
I need blood or platelet transfusions due to low blood counts.
Select...
I can take care of myself but might not be able to do heavy physical work.
Select...
I have myelodysplastic syndrome with specific blood or bone marrow conditions.
Select...
My liver and kidney functions are within normal ranges.
Select...
I am part of, or agree to join, a study collecting blood, bone marrow, and skin samples.
Select...
I am 18 years old or older.
Select...
My condition is either MDS with 20-29% bone marrow blasts or chronic myelomonocytic leukemia.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
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 moreSide effects data
From 2009 Phase 2 trial • 113 Patients • NCT0060799783%
Diarrhoea
76%
Nausea
72%
Anorexia
72%
Hypokalaemia
62%
Stomatitis
59%
Oedema peripheral
55%
Vomiting
52%
Fatigue
52%
Hypomagnesaemia
45%
Cough
45%
Hypophosphataemia
41%
Alopecia
41%
Constipation
41%
Anaemia
41%
Neutropenia
41%
Thrombocytopenia
41%
Insomnia
38%
Tachycardia
38%
Dyspnoea
38%
Hypotension
34%
Headache
34%
Febrile neutropenia
34%
Rales
31%
Asthenia
31%
Abdominal pain
28%
Chills
28%
Hypocalcaemia
28%
Petechiae
28%
Confusional state
28%
Ecchymosis
24%
Breath sounds abnormal
24%
Epistaxis
24%
Pleural effusion
24%
Rash
24%
Dehydration
24%
Anxiety
21%
Malaise
21%
Dizziness
21%
Dry mouth
21%
Weight decreased
21%
Hypertension
21%
Agitation
17%
Dyspepsia
17%
Haemorrhoids
17%
Pain
17%
Pneumonia
17%
Back pain
17%
Pruritus
17%
Dysphagia
17%
Depression
17%
Pyrexia
14%
Odynophagia
14%
Dysgeusia
14%
Haematuria
14%
Atrial fibrillation
14%
Muscular weakness
14%
Musculoskeletal pain
14%
Somnolence
14%
Pallor
14%
Hyperhidrosis
14%
International normalised ratio increased
14%
Pain in extremity
10%
Vision blurred
10%
Skin lesion
10%
Urinary incontinence
10%
Malnutrition
10%
Rash erythematous
10%
Restlessness
10%
Gastrointestinal haemorrhage
10%
Chest pain
10%
Hypoxia
10%
Staphylococcal bacteraemia
10%
Fall
10%
Skin laceration
10%
Blood creatinine increased
10%
Hyperglycaemia
10%
Myalgia
10%
Dysuria
10%
Haemoptysis
10%
Pulmonary oedema
10%
Rhonchi
10%
Sinus congestion
10%
Dry skin
10%
Candidiasis
10%
Lip dry
10%
Enterococcal bacteraemia
10%
Contusion
10%
Productive cough
10%
Transfusion reaction
7%
Rash macular
7%
Renal failure acute
7%
Incontinence
7%
Rash maculo-papular
7%
Lung infiltration
7%
Salivary hypersecretion
7%
Pseudomonal sepsis
7%
Cardiac failure congestive
7%
Catheter related complication
7%
Abdominal distension
7%
Bacteraemia
7%
Oral mucosal petechiae
7%
Musculoskeletal chest pain
7%
Pollakiuria
7%
Wheezing
7%
Leukopenia
7%
Breath odour
7%
Diverticulum
7%
Oral pain
7%
Tongue haematoma
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%
Dysarthria
7%
Hallucination
7%
Hiccups
7%
Lung disorder
7%
Pharyngolaryngeal pain
7%
Pleuritic pain
7%
Respiratory distress
7%
Night sweats
7%
Diverticulitis
7%
Wound
7%
Ejection fraction decreased
7%
Haematoma
7%
Hyponatraemia
7%
Arthralgia
7%
Delirium
7%
Urinary retention
7%
Atelectasis
7%
Blister
7%
Erythema
7%
Ear pain
3%
Respiratory failure
3%
Haemorrhage urinary tract
3%
Neuropathy peripheral
3%
Urticaria
3%
Flushing
3%
Sinus bradycardia
3%
White blood cell count decreased
3%
Nocturia
3%
Residual urine
3%
Nail disorder
3%
Periorbital oedema
3%
Rash pruritic
3%
Nasal dryness
3%
Hyperkalaemia
3%
Conjunctival haemorrhage
3%
Folliculitis
3%
Oral intake reduced
3%
Neutropenic colitis
3%
Angina pectoris
3%
Eustachian tube patulous
3%
Oesophageal stenosis
3%
Catheter site oedema
3%
Wound complication
3%
Skin turgor decreased
3%
Oesophagitis
3%
Myocardial infraction
3%
Pneumonia fungal
3%
Staphylococcal sepsis
3%
Sepsis
3%
Sinusitis
3%
Proctalgia
3%
Catheter site inflammation
3%
Tinnitus
3%
Dry eye
3%
Rhinitis
3%
Catheter related infection
3%
Pseudomonas infection
3%
Vaginal candidiasis
3%
Skin infection
3%
Pharyngeal inflammation
3%
Red man syndrome
3%
Renal cyst
3%
Deep vein thrombosis
3%
Leukoplakia
3%
Abscess
3%
Body temperature decreased
3%
Prothrombin time prolonged
3%
Myocardial ischaemia
3%
Intestinal functional disorder
3%
Hyperbilirubinaemia
3%
Cellulitis orbital
3%
Staphylococcal infection
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%
Sinus Tachycardia
3%
Ventricular extrasystoles
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%
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%
Restless legs syndrome
3%
Transient ischaemic attack
3%
Mental disorder
3%
Renal mass
3%
Vulval disorder
3%
Acute respiratory distress syndrome
3%
Diaphragmalgia
3%
Pulmonary granuloma
3%
Respiratory alkalosis
3%
Dermatitis
3%
Perivascular dermatitis
3%
Purpura
3%
Rash generalised
3%
Coagulopathy
3%
Skin Hypopigmentation
3%
Skin reaction
3%
Orthostatic hypotension
3%
Ocular hyperaemia
3%
Abdominal discomfort
3%
Facial pain
3%
Gait disturbance
3%
Infusion site pain
3%
Tooth fracture
3%
Swelling
3%
Cholecystitis
3%
Jaundice
3%
Acinetobacter bacteraemia
3%
Death
3%
Multi-Organ failure
3%
Neuralgia
3%
Septic shock
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%
Aptyalism
3%
Ascites
3%
Bowel sounds abnormal
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%
Blood glucose increased
3%
Blood testosterone decreased
3%
C-Reactive protein increased
3%
Transaminases increased
3%
Diabetes mellitus
3%
Diabetes mellitus insulin-dependent
3%
Groin pain
3%
Osteosclerosis
3%
Tremor
3%
Vulvovaginal pruritus
3%
Dyspnoea exertional
3%
Obstructive airways disorder
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%
Sinus operation
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
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
2013
Completed Phase 2
~150
Azacitidine
2012
Completed Phase 3
~1440
Find a Location
Who is running the clinical trial?
Washington University School of MedicineLead Sponsor
1,942 Previous Clinical Trials
2,304,255 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
568 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your IPSS score is INT-1 or higher during screening.Your bilirubin level should be lower than 2.0 mg/dl, unless you have Gilbert's disease.My kidney function, measured by creatinine levels or clearance, is within the normal range.I need blood or platelet transfusions due to low blood counts.I can take care of myself but might not be able to do heavy physical work.I am using or will use birth control during and for 30 days after the study.I have myelodysplastic syndrome with specific blood or bone marrow conditions.I am using or will use birth control during and for 30 days after the study.I am currently undergoing chemotherapy, radiation, or immunotherapy.I do not have any severe illnesses or social situations that would stop me from following the study's requirements.My liver and kidney functions are within normal ranges.I am part of, or agree to join, a study collecting blood, bone marrow, and skin samples.I have completed at least four cycles of a specific cancer treatment.I do not have active HIV, HBV (unless from vaccine), or HCV (unless treated and viral load is negative).You are currently pregnant or breastfeeding.I am 18 years old or older.You understand the study and agree to sign a document that explains it (or have a legal representative sign for you, if needed).My condition is either MDS with 20-29% bone marrow blasts or chronic myelomonocytic leukemia.Your liver function tests (AST and ALT) must be within 2.5 times the normal range.I may have had up to 3 treatments with specific drugs for my condition and received supportive care.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (vosaroxin, azacitidine)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
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