RecruitingPhase 2NCT04872543

A Study of ASTX727 in People With Malignant Peripheral Nerve Sheath Tumors (MPNST)

A Phase II Study of ASTX727 in Patients With PRC2 Loss Malignant Peripheral Nerve Sheath Tumor (MPNST)


Sponsor

Memorial Sloan Kettering Cancer Center

Enrollment

25 participants

Start Date

Apr 29, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to see whether the study drug ASTX727 is an effective treatment for people who have MPNST with a PCR2 mutation. ASTX727 is a combination of two drugs (cedazuridine and decitabine) that have been designed to target cancer cells with a PCR2 mutation and to disrupt the cells' ability to survive and grow. The study researchers think that the study drug allows decitabine to work better than decitabine given alone.


Eligibility

Min Age: 16 Years

Plain Language Summary

Simplified for easier understanding

This study tests ASTX727, an oral medication, in patients with a rare type of nerve tumor called malignant peripheral nerve sheath tumor (MPNST) that has a specific genetic change (loss of PRC2 function). These tumors are aggressive and often don't respond well to standard chemotherapy. **You may be eligible if...** - You are at least 16 years old - You have a confirmed MPNST with PRC2 loss (shown by specific lab tests) - Your tumor has spread or cannot be surgically removed, and has progressed after at least one standard treatment - You have at least one measurable tumor on imaging - You can take oral medications - Your kidney, liver, and blood counts are within acceptable ranges **You may NOT be eligible if...** - Your tumor does not have the required PRC2 genetic change - You have not yet tried any standard systemic (whole-body) treatment - You have severe organ dysfunction - You are pregnant or unwilling to use contraception Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGASTX727

ASTX727 will be self-administered orally by the patient on a once daily basis, days 1 through 5 of each 21-day cycle. Cycle 1 day 1 (C1D1) is defined as the first day that ASTX727 is administered.


Locations(7)

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, United States

Memorial Sloan Kettering Commack (Limited Protocol Activities)

Commack, New York, United States

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Uniondale, New York, United States

View Full Details on ClinicalTrials.gov

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NCT04872543