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Nucleoside Analog

ASTX727 for Leukemia

Phase 2

Waitlist Available

Research Sponsored by Taiho Oncology, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants must have a confirmed diagnosis of- i. MDS including all French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, CMML), and participants with MDS International Prognostic Scoring System (IPSS) int-1, -2, or high-risk MD. ii. AML, as diagnosed according to the 2016 World Health Organization (WHO) guidelines on acute leukemia, of any subtype except M3 (acute promyelocytic leukemia), who are not candidates for intensive chemotherapy, including participants receiving hypomethylating agent (HMA) treatment, who have a confirmed diagnosis and a prior confirmatory bone marrow report. Participants who are currently receiving HMA treatment must complete the ongoing (at the time of Screening) treatment cycle before enrolling in this study; timing of start of treatment cycle with ASTX727 is at the principal investigator's discretion.

Adequate organ function defined as follows: Hepatic: Total bilirubin ≤1.5 × upper limit of normal (ULN); aspartate aminotransferase/serum glutamic-oxaloacetic transaminase (AST/SGOT) and alanine aminotransferase/serum glutamic-pyruvic transaminase (ALT/SGPT) ≤5 × ULN. Renal: Calculated creatinine clearance ≥60 mL/min.

Must not have

Known history of human immunodeficiency virus or known seropositive for hepatitis C virus or hepatitis B virus.

Participants with known or suspected hypersensitivity to decitabine, cedazuridine, or any of the excipients in the ASTX727 tablets.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from day 1 up to day 28 in cycle 1 (up to 28 days)

Awards & highlights

No Placebo-Only Group

Summary

This trial is an extension of a previous study that found benefits from ASTX727 treatment. The purpose of the Food Effect Substudy is to study the effects of food on the drug's safety and how it is absorbed by the body.

Who is the study for?

This trial is for people who have certain types of leukemia or preleukemia and were previously benefiting from ASTX727 in an Astex-sponsored study. They must understand the study, not be pregnant or breastfeeding, use effective birth control, have a performance status of 0 to 2 (which measures how the disease affects daily living abilities), and adequate liver and kidney function.

What is being tested?

The trial continues treatment with ASTX727 for those who benefited from it before. It also studies how food affects the drug's absorption and safety by comparing its effects when taken with different meals versus no meal at all.

What are the potential side effects?

While specific side effects are not listed here, participants will be monitored for any adverse reactions related to ASTX727 which could include typical chemotherapy-related issues such as digestive problems, blood disorders, fatigue, or potential organ dysfunction.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with a specific type of blood cancer and cannot undergo intensive chemotherapy.

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My liver and kidney functions are within the required range.

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I can take care of myself and am up and about more than half of my waking hours.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of HIV or tested positive for hepatitis B or C.

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I am not allergic to decitabine, cedazuridine, or any ingredients in ASTX727 tablets.

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I have an active stomach or upper small intestine ulcer that's not under control.

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I have had stomach surgery that affects how my stomach moves or absorbs food.

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I have acute promyelocytic leukemia.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from day 1 up to day 28 in cycle 1 (up to 28 days)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from day 1 up to day 28 in cycle 1 (up to 28 days)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from day 1 up to day 28 in cycle 1 (up to 28 days) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Main Extension Study: Safety: Number of Participants with Treatment-Emergent Adverse Events (TEAEs)

Secondary study objectives

Food Effect Substudy: Percentage of Participants with Clinically Significant Abnormal Laboratory Values

Therapeutic procedure

Side effects data

From 2023 Phase 3 trial • 227 Patients • NCT03306264

39%

Thrombocytopenia

36%

Anaemia

34%

Neutropenia

20%

Constipation

17%

Leukopenia

17%

Nausea

17%

Fatigue

14%

Headache

11%

Diarrhoea

11%

Oropharyngeal Pain

10%

Dizziness

Dyspnoea

Pyrexia

Cough

Oedema Peripheral

Back Pain

Febrile neutropenia

Pneumonia

Myalgia

Alanine Aminotransferase Increased

Asthenia

Arthralgia

Decreased Appetite

Hypokalaemia

Epistaxis

Hypotension

Pain In Extremity

Abdominal Pain

Pain

Lymphopenia

Petechiae

Stomatitis

Vomiting

Anxiety

Fall

Blood Alkaline Phosphatase Increased

Hypomagnesaemia

Hyponatraemia

Nasal Congestion

Rash Maculo-Papular

Blood Creatinine Increased

Aspartate Aminotransferase Increased

Hypocalcaemia

Rash

Upper Respiratory Tract Infection

Bone Pain

Musculoskeletal Pain

Insomnia

Rhinitis Allergic

Alopecia

Hypoalbuminaemia

Non-Cardiac Chest Pain

Blood Bilirubin Increased

Weight Decreased

Hyperglycaemia

Rhinorrhoea

Peripheral Swelling

Cellulitis

Hypertension

Toothache

Chills

Haematuria

Pruritus

Febrile Neutropenia

Dyspepsia

Contusion

Night Sweats

Pancytopenia

Depression

Hip fracture

Dehydration

Dyspnoea Exertional

Haemorrhoids

Deep vein thrombosis

Conjunctival Haemorrhage

Muscle Spasms

Vascular device infection

Angioedema

Skin Lesion

Haemoptysis

Septic shock

Syncope

Neck Pain

Acute myocardial infarction

Hyperbilirubinaemia

Migraine

Acute kidney injury

Respiratory failure

Acute respiratory distress syndrome

Nasopharyngitis

Pollakiuria

100%

80%

60%

40%

20%

Study treatment Arm

MDS or CMML: IV Decitabine

MDS or CMML: Not Treated

AML: Not Treated

AML: IV Decitabine

AML: ASTX727

MDS or CMML: ASTX727

Awards & Highlights

No Placebo-Only Group

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

Trial Design

3Treatment groups

Experimental Treatment

Group I: Substudy Arm B: ASTX727 With Low-Calorie/Low-Fat Breakfast Meal on Day 4Experimental Treatment1 Intervention

Participants received ASTX727 once daily on Days 1 through 5 in a 28-day cycle (Cycle 1). Participants fasted for at least 2 hours before and 2 hours after dosing on Days 1, 3, 5 and for at least 10 hours before and 4 hours after dosing on Day 2. Participants received low-calorie/low-fat breakfast meal after an overnight fast of at least 10 hours before dosing on Day 4 and will continue to fast for at least 4 hours post-dose. Participants continued treatment with ASTX727 in Cycle 2 onwards in the ASTX727-06 study at the Investigator's discretion, where they continued to receive ASTX727 unless there was occurrence of disease progression requiring alternative therapy, unacceptable toxicity, noncompliance, a decision to discontinue treatment, or if the participant withdraws from the study.

Group II: Substudy Arm A: ASTX727 With High-Calorie/High-Fat Breakfast Meal on Day 4Experimental Treatment1 Intervention

Participants received ASTX727 once daily on Days 1 through 5 in a 28-day cycle (Cycle 1). Participants fasted for at least 2 hours before and 2 hours after dosing on Days 1, 3, 5 and for at least 10 hours before and 4 hours after dosing on Day 2. Participants received a high-calorie/high-fat breakfast meal after an overnight fast of at least 10 hours before dosing on Day 4 and continued to fast for at least 4 hours post-dose. Participants continued treatment with ASTX727 in Cycle 2 onwards in the ASTX727-06 study at the Investigator's discretion, where they continued to receive ASTX727 unless there was occurrence of disease progression requiring alternative therapy, unacceptable toxicity, noncompliance, a decision to discontinue treatment, or if the participant withdraws from the study.

Group III: Main Extension Study: ASTX727Experimental Treatment1 Intervention

The recommended starting dose is the fixed-dose combination (FDC) standard dose (SD) tablet, containing 100 mg cedazuridine and 35 mg decitabine, once daily, Days 1 through 5 in 28-day cycles. Participants should receive ASTX727 at the same dose they received in the last cycle of their parent study; if an adjustment from that dose is required, a different total cycle dose may be employed, as guided by the dose adjustment guidelines in the parent study protocol.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

ASTX727

2018

Completed Phase 3

~270

0 / 8Eligibility criteria met