A Phase II/III Study of REC-2282 in People with NF2-Mutated Meningiomas

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Full Title

A Two-staged, Phase 2/3, Randomized, Multicenter Study to Evaluate the Efficacy and Safety of REC-2282 in Participants with Progressive NF2 Mutated Meningiomas

Purpose

The purpose of this study is to find the highest dose of the investigational drug REC-2282 that can be given safely in people with meningiomas that contain a mutation in the neurofibromatosis type 2 (NF2) gene. REC-2282 blocks an enzyme called HDAC, which is involved in the growth of tumor cells, including NF2-mutated meningiomas. By blocking HDAC, REC-2282 may help stop these tumors from growing and also kill tumor cells. Researchers think REC-2282 could work as well as surgery and radiotherapy, the standard treatments for this type of tumor. REC-2282 is taken orally (by mouth).

Who Can Join

To be eligible for this study, patients must meet several requirements, including:

  • Participants must have NF2-mutated meningioma of at least 1 cm in size.
  • At least 3 months must pass between the completion of prior anticancer medications and 6 months since surgery or radiation therapy and receipt of REC-2282.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for people age 12 and older.

Contact

For more information and to ask about eligibility for this study, please contact the office of Dr. Thomas Kaley at 212-639-5122 or the Brain Tumor Hotline at 866-886-9807.

Protocol

22-372

Phase

Phase II/III (phases 2 and 3 combined)

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators

ClinicalTrials.gov ID

NCT05130866