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Nucleoside Analog

ASTX727 for Myelodysplastic Syndrome

Phase 3

Waitlist Available

Research Sponsored by Astex Pharmaceuticals, Inc.

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 approximately 2.7 years

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing a new drug, ASTX727, to see if it is as good as the current standard treatment, decitabine, for adult patients with cancer.

Eligible Conditions

Myelodysplastic Syndrome
Acute Myeloid Leukemia
Chronic Myelomonocytic Leukemia

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 2.7 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 2.7 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 2.7 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

Total 5-day Area Under the Curve From 0 to 24 Hours (AUC0-24) After Treatment With ASTX727 And IV Decitabine

Secondary study objectives

AML: Duration of Complete Response and Combined CR and CRh Based on IWG 2003 AML Response Criteria

AML: Event-free Survival (EFS)

AML: Number of Participants With Grade 3 or Higher TEAEs

+24 more

Side effects data

From 2023 Phase 3 trial • 227 Patients • NCT03306264

69%

Thrombocytopenia

61%

Neutropenia

55%

Anaemia

52%

Fatigue

49%

Constipation

48%

Nausea

42%

Diarrhoea

38%

Headache

35%

Dyspnoea

33%

Decreased Appetite

32%

Dizziness

31%

Cough

28%

Leukopenia

28%

Oedema Peripheral

25%

Arthralgia

25%

Febrile neutropenia

22%

Asthenia

21%

Hypokalaemia

21%

Pyrexia

20%

Oropharyngeal Pain

20%

Vomiting

20%

Back Pain

18%

Contusion

18%

Stomatitis

16%

Myalgia

15%

Abdominal Pain

15%

Alanine Aminotransferase Increased

15%

Insomnia

14%

Pain In Extremity

13%

Blood Creatinine Increased

13%

Rash Maculo-Papular

13%

Pneumonia

12%

Nasal Congestion

12%

Hypotension

12%

Fall

12%

Epistaxis

12%

Rash

12%

Upper Respiratory Tract Infection

12%

Urinary Tract Infection

11%

Aspartate Aminotransferase Increased

11%

Hypocalcaemia

11%

Hyperglycaemia

10%

Chills

10%

Muscle Spasms

10%

Alopecia

Hyponatraemia

Petechiae

Depression

Cellulitis

Blood Alkaline Phosphatase Increased

Weight Decreased

Bone Pain

Nasopharyngitis

Blood Bilirubin Increased

Sepsis

Haematuria

Anxiety

Hypertension

Pruritus

Hypoalbuminaemia

Toothache

Non-Cardiac Chest Pain

Hypomagnesaemia

Haemorrhoids

Dyspepsia

Lymphopenia

Pain

Neck Pain

Skin Lesion

Musculoskeletal Pain

Peripheral Swelling

Pollakiuria

Dehydration

Conjunctival Haemorrhage

Rhinorrhoea

Night Sweats

Febrile Neutropenia

Dyspnoea Exertional

Rhinitis Allergic

Procedural Pain

Proctitis

Myocardial infarction

Gastrointestinal haemorrhage

Embolism

Colitis

Diverticulitis

Syncope

Pneumothorax

Upper respiratory tract infection

Influenza

Chronic obstructive pulmonary disease

Respiratory failure

Rib fracture

Pharyngitis

Rectal haemorrhage

Aplasia pure red cell

Enteritis

Oedema peripheral

Spinal fracture

Suicide attempt

Pleural effusion

Embolism arterial

Gingival bleeding

Pneumonia cytomegaloviral

Peritonsillitis

Pseudomonal bacteraemia

Refractory cytopenia with unilineage dysplasia

Pancreatic carcinoma metastatic

Influenza A virus test positive

Cerebral haemorrhage

Proctalgia

Upper gastrointestinal haemorrhage

Cholelithiasis

Bacteraemia

Bronchopulmonary aspergillosis

Device related infection

Gastroenteritis viral

Sinusitis fungal

Post procedural haematoma

Decreased appetite

Transient ischaemic attack

Angioedema

Hypersensitivity vasculitis

Deep vein thrombosis

Haematoma

Thrombotic thrombocytopenic purpura

Urinary tract infection

Clostridium difficile colitis

Adenocarcinoma gastric

Enterobacter infection

Gastroenteritis Escherichia coli

Pyoderma gangrenosum

Parainfluenzae virus infection

Acute coronary syndrome

Small intestinal obstruction

Colonic abscess

Oral candidiasis

Septic shock

Limb injury

Soft tissue necrosis

Pulmonary embolism

100%

80%

60%

40%

20%

Study treatment Arm

MDS or CMML: ASTX727

AML: IV Decitabine

MDS or CMML: Not Treated

AML: Not Treated

AML: ASTX727

MDS or CMML: IV Decitabine

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

4Treatment groups

Experimental Treatment

Group I: MDS or CMML: Sequence B: First IV Decitabine, Then ASTX727, Then ASTX727Experimental Treatment2 Interventions

Participants with MDS or CMML received IV infusion of decitabine 20 mg/m\^2, once daily, on Days 1 to 5 in cycle 1 (each cycle = 28 days) followed by ASTX727 tablet, containing the fixed-dose combination of 35 mg decitabine and 100 mg cedazuridine, orally, once daily, on Days 1 to 5 in cycle 2. A washout period of 23 days was maintained between the 2 cycles. From cycle 3, all participants enrolled in cycles 1 and 2 received ASTX727 tablet, once daily, on Days 1 to 5 of each 28-day cycle until disease progression, unacceptable toxicity, treatment discontinuation for other reasons, or withdrawal from the study.

Group II: MDS or CMML: Sequence A: First ASTX727, Then IV Decitabine, Then ASTX727Experimental Treatment2 Interventions

Participants with MDS or CMML received ASTX727 tablet, containing the fixed-dose combination of 35 mg decitabine and 100 mg cedazuridine, orally, once daily, on Days 1 to 5 in cycle 1 (each cycle = 28 days), followed by IV infusion of decitabine 20 mg/m\^2, once daily, on Days 1 to 5 in cycle 2. A washout period of 23 days was maintained between the 2 cycles. From cycle 3, all participants enrolled in cycles 1 and 2 received ASTX727 tablet, once daily, on Days 1 to 5 of each 28-day cycle until disease progression, unacceptable toxicity, treatment discontinuation for other reasons, or withdrawal from the study.

Group III: AML: Sequence B: First IV Decitabine, Then ASTX727, Then ASTX727Experimental Treatment2 Interventions

Participants with AML received IV infusion of decitabine 20 mg/m\^2, once daily, on Days 1 to 5 in cycle 1 (each cycle = 28 days) followed by ASTX727 tablet, containing the fixed-dose combination of 35 mg decitabine and 100 mg cedazuridine, orally, once daily, on Days 1 to 5 in cycle 2. A washout period of 23 days was maintained between the 2 cycles. From cycle 3, all participants enrolled in cycles 1 and 2 received ASTX727 tablet, once daily, on Days 1 to 5 of each 28-day cycle until disease progression, unacceptable toxicity, participant discontinued treatment, or was withdrawn from the study.

Group IV: AML: Sequence A: First ASTX727, Then IV Decitabine, Then ASTX727Experimental Treatment2 Interventions

Participants with AML received ASTX727 tablet, containing the fixed-dose combination of 35 mg decitabine and 100 mg cedazuridine, orally, once daily, on Days 1 to 5 in cycle 1 (each cycle = 28 days), followed by IV infusion of decitabine 20 mg/m\^2, once daily, on Days 1 to 5 in cycle 2. A washout period of 23 days was maintained between the 2 cycles. From cycle 3, all participants enrolled in cycles 1 and 2 received ASTX727 tablet, once daily, on Days 1 to 5 of each 28-day cycle until disease progression, unacceptable toxicity, participant discontinued treatment, or was withdrawn from the study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cedazuridine

FDA approved

Decitabine

FDA approved

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