A Phase II Study of ASTX727 in People with Malignant Peripheral Nerve Sheath Tumors

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Full Title

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

Purpose

This study is assessing the safety and effectiveness of ASTX727 in people who have malignant peripheral nerve sheath tumors (MPNST) with a mutation in a gene complex called PRC2 (EED or SUZ12). ASTX727 is a combination of two drugs (cedazuridine and decitabine) that have been designed to target cancer cells with a PRC2 complex genetic mutation and disrupt the cells’ ability to survive and grow.

Researchers think that ASTX727 allows decitabine to be taken orally (by mouth) while maintaining the same effectiveness as intravenous administration (by vein). They believe that PRC2 loss may make tumors more sensitive to ASTX727. ASTX727 is already used to treat chronic myelomonocytic leukemia and myelodysplastic syndromes; its use in this study is considered investigational. ASTX727 is taken orally.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have inoperable or metastatic MPNST that has continued to grow despite prior treatment and contains a PRC2 complex (EED or SUZ12) mutation.
  • Patients should recover from the serious side effects of previous treatment before receiving ASTX727.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Ping Chi at 646-888-4166.

Protocol

21-048

Phase

II

Investigator

Co-Investigators