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Anti-metabolites

ASTX727 for Peripheral Nerve Sheath Tumor

Phase 2

Recruiting

Led By Ping Chi, MD, PhD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

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

Must have

Patients must be at least 18 years of age

Patients must have advanced, unresectable or metastatic MPNSTs

Must not have

Left ventricular ejection fraction (LVEF) <50% as determined by a multigated acquisition (MUGA) scan or echocardiogram

Patients had a major surgery within 3 weeks prior to study entry or who have not recovered from side effects of such procedure

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at the end of 16 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether ASTX727 is an effective treatment for people who have MPNST with a PCR2 mutation.

Who is the study for?

This trial is for adults with malignant peripheral nerve sheath tumors (MPNST) that have a specific mutation called PCR2. Participants must have tried at least one standard treatment or be unsuitable for chemotherapy, and their cancer should be advanced and measurable. They need to be in fair health overall, able to take pills, not pregnant or breastfeeding, willing to use contraception, and without certain heart conditions or recent major surgeries.

What is being tested?

ASTX727 is being tested as a potential treatment for MPNST with PCR2 mutation. It's a combo of cedazuridine and decitabine designed to target cancer cells more effectively than decitabine alone by disrupting the tumor cells' survival mechanisms.

What are the potential side effects?

While the exact side effects are not listed here, ASTX727 includes decitabine which can cause low blood cell counts leading to increased infection risk, bleeding issues, fatigue; gastrointestinal symptoms like nausea; liver function changes; and infusion-related reactions.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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My cancer cannot be removed by surgery and has spread.

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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 tumor is confirmed to lack PRC2.

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I can take pills by mouth.

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My cancer has worsened after treatment, or chemotherapy isn't right for me.

Exclusion Criteria

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

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My heart's pumping ability is below 50%.

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I had major surgery less than 3 weeks ago or am still recovering from it.

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I have a digestive system condition.

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I do not have active hepatitis C or B, nor an active HIV infection.

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I have active tuberculosis.

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I have a cancer that cannot be removed by surgery and is spreading.

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I have active brain metastasis or leptomeningeal disease.

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I haven't had any cancer treatment in the last 14 days.

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I have a serious heart condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at the end of 16 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at the end of 16 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and at the end of 16 weeks for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

the best clinical benefit rate (CBR)

Secondary study objectives

objective response rate (ORR)

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%

Oropharyngeal Pain

11%

Diarrhoea

10%

Dizziness

Dyspnoea

Pyrexia

Cough

Oedema Peripheral

Back Pain

Febrile neutropenia

Alanine Aminotransferase Increased

Arthralgia

Myalgia

Epistaxis

Asthenia

Decreased Appetite

Pneumonia

Hypokalaemia

Hypotension

Abdominal Pain

Stomatitis

Pain In Extremity

Pain

Lymphopenia

Petechiae

Vomiting

Fall

Blood Alkaline Phosphatase Increased

Rash Maculo-Papular

Blood Creatinine Increased

Hypomagnesaemia

Hyponatraemia

Aspartate Aminotransferase Increased

Nasal Congestion

Hypocalcaemia

Rash

Anxiety

Upper Respiratory Tract Infection

Rhinitis Allergic

Rhinorrhoea

Peripheral Swelling

Non-Cardiac Chest Pain

Contusion

Hyperglycaemia

Night Sweats

Febrile Neutropenia

Haematuria

Insomnia

Hypoalbuminaemia

Bone Pain

Pruritus

Toothache

Chills

Blood Bilirubin Increased

Cellulitis

Dyspepsia

Alopecia

Weight Decreased

Hypertension

Musculoskeletal Pain

Haemoptysis

Acute myocardial infarction

Hip fracture

Acute kidney injury

Dehydration

Hyperbilirubinaemia

Deep vein thrombosis

Muscle Spasms

Haemorrhoids

Pollakiuria

Conjunctival Haemorrhage

Depression

Pancytopenia

Vascular device infection

Angioedema

Skin Lesion

Respiratory failure

Dyspnoea Exertional

Syncope

Nasopharyngitis

Migraine

Acute respiratory distress syndrome

Septic shock

Neck Pain

100%

80%

60%

40%

20%

Study treatment Arm

MDS or CMML: IV Decitabine

MDS or CMML: ASTX727

MDS or CMML: Not Treated

AML: Not Treated

AML: IV Decitabine

AML: ASTX727

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: ASTX727 (cedazuridine and decitabine)Experimental Treatment1 Intervention

Patients who meet the eligibility criteria will be treated with oral ASTX727 (INQOVI) on days 1-5 of each 21-day cycle with Pegfilgrastim support on day 7. A delay in the start of subsequent cycles due to holidays, weather, or other circumstances will be permitted up to 7 days and not considered a protocol deviation. Drug dosing will be interrupted for any Grade 4 adverse events or clinically significant laboratory abnormalities. For Grade 3 or 4 AE, if the AE returns to Grade 1 or baseline, the patient may be re-escalated.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

ASTX727

2018

Completed Phase 3

~270

0 / 15Eligibility criteria met