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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

38%

Thrombocytopenia

27%

Anaemia

10%

Neutropenia

10%

Oedema Peripheral

10%

Constipation

Pyrexia

Asthenia

Decreased Appetite

Febrile neutropenia

Pneumonia

Nausea

Hypokalaemia

Leukopenia

Fall

Back Pain

Insomnia

Haematoma

Dyspnoea

Vomiting

C-Reactive Protein Increased

Weight Decreased

Hypertension

Fatigue

Dry Mouth

Epistaxis

Headache

Pain

Escherichia Bacteraemia

Cellulitis

Dizziness

Cough

Atrial Fibrillation

Oral Herpes

Arthralgia

Confusional State

Acute Kidney Injury

Neutropenic Sepsis

Acute kidney injury

Diarrhoea

Alanine Aminotransferase Increased

Blood Creatinine Increased

Tachycardia

Septic shock

Aspartate Aminotransferase Increased

Haematotoxicity

Device related infection

Renal Failure

Pleural Effusion

Hypomagnesaemia

Bacteraemia

Sinusitis Aspergillus

Febrile Neutropenia

Urinary Tract Infection

Tongue Ulceration

Infection

Phlebitis

100%

80%

60%

40%

20%

Study treatment Arm

AML: IV Decitabine

MDS or CMML: ASTX727

MDS or CMML: Not Treated

AML: Not Treated

AML: ASTX727

MDS or CMML: IV Decitabine

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