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Anti-metabolites

Oral Azacitidine for Myelodysplastic Syndrome

Phase 2 & 3
Waitlist Available
Research Sponsored by Bristol-Myers Squibb
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years after discontinuation of investigational product, approximately 6 years

Summary

This trial will test how well azacitidine works in treating people with MDS.

Who is the study for?
This trial is for people with a specific blood disorder called Myelodysplastic Syndrome (MDS) that's not too advanced. They should be able to do daily activities on their own or with little help, and haven't been treated with drugs like azacitidine before. People who've had other cancers must be in good health and not have received cancer treatment recently.
What is being tested?
The study tests if oral azacitidine helps patients with low- to intermediate-risk MDS better than a placebo. Both groups also get the best supportive care available. The main goal is to see which group has better health outcomes.
What are the potential side effects?
Oral azacitidine can cause side effects such as nausea, vomiting, diarrhea, constipation, loss of appetite, and fatigue. It might also lower blood cell counts leading to anemia or increased risk of infection.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years after discontinuation of investigational product, approximately 6 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years after discontinuation of investigational product, approximately 6 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of participants who achieved complete remission (CR) per International Working Group (IWG) 2006 criteria within 6 cycles
Secondary study objectives
Best
CR duration
Event-free Survival (EFS)
+17 more

Side effects data

From 2023 Phase 3 trial • 216 Patients • NCT01566695
76%
Nausea
68%
Diarrhoea
63%
Vomiting
49%
Neutropenia
47%
Constipation
28%
Pyrexia
27%
Thrombocytopenia
27%
Febrile neutropenia
27%
Oedema peripheral
26%
Epistaxis
25%
Decreased appetite
23%
Asthenia
21%
Fatigue
20%
Petechiae
18%
Anaemia
15%
Cough
14%
Contusion
13%
Abdominal pain
12%
Dyspnoea
12%
Back pain
11%
Urinary tract infection
11%
Hypokalaemia
9%
Leukopenia
9%
Weight decreased
9%
Insomnia
9%
Pneumonia
9%
Mouth haemorrhage
9%
Hypomagnesaemia
9%
Haematoma
8%
Anxiety
8%
Alanine aminotransferase increased
8%
Arthralgia
7%
Sepsis
7%
Dizziness
7%
Gingival bleeding
7%
Upper respiratory tract infection
7%
Pain in extremity
6%
Depression
6%
Confusional state
6%
Septic shock
6%
Gastrooesophageal reflux disease
6%
Cellulitis
6%
Oral herpes
6%
Serum ferritin increased
6%
Hyperglycaemia
6%
Iron overload
6%
Ecchymosis
6%
Hypotension
5%
Neutropenic sepsis
4%
Fall
3%
Lung infection
3%
General physical health deterioration
3%
Cardiac failure congestive
2%
Tachyarrhythmia
2%
Bone marrow failure
2%
Cardiac failure
2%
Multiple organ dysfunction syndrome
2%
Cholecystitis
2%
Hyperbilirubinaemia
2%
Atypical pneumonia
2%
Bronchopulmonary aspergillosis
2%
Subdural haematoma
2%
Haemorrhage intracranial
2%
Acute kidney injury
2%
Renal failure
1%
Myocardial infarction
1%
Gastritis
1%
Corona virus infection
1%
Pancytopenia
1%
Abdominal pain upper
1%
Epididymitis
1%
Escherichia sepsis
1%
Febrile infection
1%
Gastroenteritis
1%
Prerenal failure
1%
Renal colic
1%
Chronic kidney disease
1%
Lethargy
1%
Groin abscess
1%
Lower respiratory tract infection
1%
Device related infection
1%
Influenza
1%
Klebsiella infection
1%
Haemolytic anaemia
1%
Haemorrhagic anaemia
1%
Acute myocardial infarction
1%
Angina unstable
1%
Atrial fibrillation
1%
Gastrointestinal haemorrhage
1%
Intestinal obstruction
1%
Intestinal perforation
1%
Neutropenic colitis
1%
Oesophageal achalasia
1%
Oral mucosal blistering
1%
Rectal haemorrhage
1%
Gait disturbance
1%
Hypothermia
1%
Abscess limb
1%
Arteriovenous fistula site infection
1%
Klebsiella sepsis
1%
Meningitis
1%
Meningitis bacterial
1%
Myringitis
1%
Pneumonia fungal
1%
Pneumonia pneumococcal
1%
Pseudomonal sepsis
1%
Pulmonary mycosis
1%
Respiratory tract infection
1%
Skin infection
1%
Staphylococcal infection
1%
Urinary tract infection bacterial
1%
Viral sepsis
1%
Periorbital haematoma
1%
Febrile nonhaemolytic transfusion reaction
1%
Head injury
1%
Hip fracture
1%
Subdural haemorrhage
1%
Upper limb fracture
1%
Dehydration
1%
Diabetes mellitus inadequate control
1%
Diabetic metabolic decompensation
1%
Hyperkalaemia
1%
Hypoglycaemia
1%
Muscular weakness
1%
Polychondritis
1%
Acute myeloid leukaemia
1%
Bone neoplasm
1%
Bowen's disease
1%
Colon adenoma
1%
Mantle cell lymphoma recurrent
1%
Spinal cord neoplasm
1%
Central nervous system lesion
1%
Transient ischaemic attack
1%
Epilepsy
1%
Generalised tonic-clonic seizure
1%
Acute respiratory distress syndrome
1%
Pleural effusion
1%
Pleurisy
1%
Pneumonia aspiration
1%
Pulmonary embolism
1%
Respiratory failure
1%
Hypersensitivity vasculitis
1%
Rash
1%
Rash generalised
1%
Shock haemorrhagic
1%
Cardiogenic shock
1%
Intra-abdominal haemorrhage
1%
Status epilepticus
1%
Syncope
1%
Urinary retention
1%
Prostatitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Oral Azacitidine Plus Best Supportive Care
Placebo Plus Best Supportive Care

Trial Design

4Treatment groups
Experimental Treatment
Group I: Part II - PlaceboExperimental Treatment1 Intervention
Group II: Part II - Oral-Aza (RP3D)Experimental Treatment1 Intervention
RP3D: Recommended Phase 3 Dose
Group III: Part I - Oral-Aza (Dose 2)Experimental Treatment1 Intervention
Group IV: Part I - Oral-Aza (Dose 1)Experimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Oral Azacitidine
2013
Completed Phase 3
~950

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor
2,681 Previous Clinical Trials
4,124,783 Total Patients Enrolled

Media Library

Oral Azacitidine (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT05469737 — Phase 2 & 3
Myelodysplastic Syndrome Research Study Groups: Part II - Oral-Aza (RP3D), Part I - Oral-Aza (Dose 2), Part II - Placebo, Part I - Oral-Aza (Dose 1)
Myelodysplastic Syndrome Clinical Trial 2023: Oral Azacitidine Highlights & Side Effects. Trial Name: NCT05469737 — Phase 2 & 3
Oral Azacitidine (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05469737 — Phase 2 & 3
~87 spots leftby Jan 2026
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