Study on ASTX727 for Treating Malignant Peripheral Nerve Sheath Tumors (MPNST)

Sponsor: Memorial Sloan Kettering Cancer Center

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT04872543

Provider View

This clinical trial is testing whether the drug ASTX727, a combination of cedazuridine and decitabine, can effectively treat people with Malignant Peripheral Nerve Sheath Tumors (MPNST) that have a specific genetic mutation called PCR2.

Patient Parameters

Program Overview

The purpose of this study is to find out if the drug ASTX727 can help treat people with Malignant Peripheral Nerve Sheath Tumors (MPNST) that have a PCR2 mutation. ASTX727 combines two drugs, cedazuridine and decitabine, which are designed to target cancer cells with this mutation and stop them from growing. Researchers believe that ASTX727 may work better than decitabine alone in treating these tumors.

Eligibility Criteria

Inclusion Criteria

  • Must have a confirmed diagnosis of MPNST with a specific genetic mutation (PCR2 loss) that is advanced, cannot be removed by surgery, or has spread, and has not responded to at least one standard treatment.
  • Must be 18 years or older.
  • Must be in relatively good health, with a performance status score of 2 or less, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • The disease must be measurable by standard criteria.
  • Must be able to take oral medications.
  • Must understand and agree to the study requirements and sign a consent form.
  • Must have adequate kidney, liver, and blood function as determined by specific blood tests.
  • Women of childbearing potential must have a negative pregnancy test before starting the study and agree to use two reliable methods of contraception during and for six months after treatment.
  • Women must agree not to breastfeed during treatment and for two weeks after the last dose.
  • Sexually active men must agree to use a condom during intercourse and not donate sperm while taking the drug and for three months after stopping treatment.

Exclusion Criteria

  • Have a severe or uncontrolled medical condition, such as uncontrolled diabetes or chronic kidney disease.
  • Have active cancer in the brain or spinal fluid.
  • Have active or chronic infections like hepatitis B, hepatitis C, or HIV, unless previously treated and under control.
  • Have active tuberculosis.
  • Have another active cancer that cannot be operated on or has spread, unless it is not expected to interfere with the study.
  • Have significant heart disease, such as recent heart attack or heart failure.
  • Have a heart rhythm problem or low heart function as determined by specific tests.
  • Have had a blood clot or stroke within three months before starting the study.
  • Have digestive problems that affect the ability to absorb medication.
  • Have had major surgery within three weeks before starting the study or have not recovered from its effects.
  • Have a history of not following medical advice or cannot give reliable consent.
  • Have received cancer treatment within 14 days before starting the study, or within 28 days for certain biological therapies.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.