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
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The purpose of this study is to find out if REC-2282, an investigational new drug, is an effective and safe treatment in patients with progressive NF2 mutated meningiomas who have either NF2 disease-related meningioma or recurrent sporadic meningiomas that have NF2 mutation. “Investigational new drug” means a drug that has not been approved as a marketed product (i.e., available to be prescribed or sold) by any regulatory authorities, such as the US Food and Drug Administration (FDA). REC-2282 is a potential treatment for a variety of tumors where various enzymes and proteins play a large role in uncontrolled tumor growth, such as in tumors due to NF2 mutations. The NF2 gene encodes a tumor suppressor protein called merlin. In normal cells, merlin regulates cell growth and communication. In NF2 mutations, the loss of merlin protein leads to abnormal cell behavior and tumor growth. Currently, there are no approved medical therapies for the treatment of progressive NF2 mutated meningiomas, which account for about 50% of all meningiomas. Participants who agree to be in this study will take tablets containing the study drug. To help determine the effective dose of study drug, people will be put into 2 groups. The groups are selected by chance, like tossing a coin or drawing names out of a hat. About 50% of participants will receive 40 mg of study drug and about 50% of participants will receive 60 mg of study drug.
Are you Eligible? (Inclusion Criteria)
- Must be 18 years old or older. - Must be willing and able to comply with protocol requirements. - Must not have progressive disease associated with significant or disabling clinical symptoms likely to require surgery or radiation therapy within the next 3 months. - Must not be pregnant, lactating, or planning to attempt to become pregnant or impregnate someone during this study or within 90 days after the last dose of the study drug.
