Efficacy and Safety of REC-2282 in Participants with Progressive NF2 Mutated Meningiomas
Research type
Research Study
Full title
A Parallel-group, Two-staged, Phase 2/3, Randomized, Multicenter Study to Evaluate the Efficacy and Safety of REC-2282 in Participants with Progressive NF2 Mutated Meningiomas
IRAS ID
1004613
Contact name
Meredith Brown-Tuttle
Contact email
Sponsor organisation
Recursion Pharmaceuticals, Inc.
Eudract number
2021-003169-36
Clinicaltrials.gov Identifier
Research summary
Neurofibromatosis type 2 (NF2) is a disease that makes affected individuals liable to nervous system tumours (like meningiomas). Approximately one-half of individuals with NF2 have meningiomas and most of these individuals will have multiple meningiomas. Current treatment involves either surgery or radiotherapy Although most meningiomas are benign, their location often makes complete removal not possible due to potential to cause further damage. Subsequently, patients with NF2 experience loss of hearing, facial paralysis, poor balance, and visual difficulty. Spinal tumours can result in weakness and disability and many patients with multi-tumour disease die in early adulthood.
REC-2282 is a drug developed to inhibit Histone deacetylase (HDAC) enzymes. Inhibition of HDAC has been reported to result in decreases in human meningioma and schwannoma (tumour) cell growth. The activity of REC-2282 as a HDAC inhibitor has been established in cancer cell lines and mouse models, both of which have shown inhibition of tumour growth. Orally administered REC-2282 has also been indicated to penetrate the blood-barrier.
This study will assess the safety and effectiveness of REC-2282 compared to placebo. Approximately 89 participants will be enrolled into two cohorts. Cohort A contains approximately 29 participants who will receive REC-2282 for approximately 2 years. Study follow up will be undertaken 4 weeks and 6 months after end of trial (EOT). The first 8 adult participants to be enrolled in the study will be randomised into a sub-study to evaluate the effect of food on REC-2282 exposure.
Cohort B contains approximately 60 participants who will receive REC-2282 or placebo for up to 39 cycles, or two years after the last participant is randomised. Follow-up will occur at 4 weeks and 6 months after EOT.
The study is funded by Recursion Pharmaceuticals Inc. and will take place at 1 study centres in the UK.
REC name
London - Hampstead Research Ethics Committee
REC reference
22/LO/0572
Date of REC Opinion
6 Feb 2023
REC opinion
Further Information Favourable Opinion