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

Conditions

• Malignant Peripheral Nerve Sheath Tumors (MPNST)

Eligibility Criteria

Sex

ALL

Age

16 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• ASTX727 — DRUG
  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.

Study Details

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.

Key Dates

Start date

Apr 29, 2021

Status verified

Feb 2026

Primary completion

Apr 30, 2027

Completion

Apr 30, 2027

Study Design

Enrollment

25 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: ASTX727 (cedazuridine and decitabine)
  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.

Primary Outcome Measure

the best clinical benefit rate (CBR) [ Time Frame: at the end of 16 weeks ]

Central Contacts

• Ping Chi, MD, PhD
  646-888-4166
  [email protected]
• Ciara Kelly, MBBCH BAO
  646-888-4312
  [email protected]

Locations (7)

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