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REC-2282 for Meningioma (POPLAR-NF2 Trial)

Phase 2 & 3

Recruiting

Research Sponsored by Recursion Pharmaceuticals Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

≥12 years of age and weighing at least 40 kg

Has either 1) sporadic meningioma with confirmed NF2 mutation; or, 2) confirmed diagnosis of NF2 disease (revised Manchester criteria); or, 3) at least one NF2-related tumor (with pathogenic germline or proven mosaic NF2 variant)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up time from the date of randomization until disease progression or death from any cause, whichever occurs first, assessed up to 24 months.

Awards & highlights

POPLAR-NF2 Trial Summary

This trial is testing a new drug to treat patients with a specific type of brain tumor. The drug will be given to two groups of patients to see if it is effective and safe.

Who is the study for?

This trial is for individuals aged 12 or older, weighing at least 40 kg, with progressive meningiomas linked to NF2 mutations. Participants must have adequate bone marrow function and provide consent. It's not for those likely needing surgery soon, who've had recent tumor treatments or other clinical trials drugs, are pregnant or planning pregnancy within 90 days post-trial.Check my eligibility

What is being tested?

The study compares the effectiveness and safety of a new medication called REC-2282 against a placebo in patients with NF2 mutated meningiomas. The trial randomly assigns participants to either group and measures how well the tumors respond to treatment.See study design

What are the potential side effects?

While specific side effects of REC-2282 aren't listed here, common ones may include fatigue, nausea, headaches, allergic reactions or blood count changes. Side effects vary by individual and should be monitored closely.

POPLAR-NF2 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 12 years or older and weigh at least 40 kg.

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I have a confirmed NF2 mutation or diagnosis.

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My meningioma is growing and can be measured.

POPLAR-NF2 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ time from the date of randomization until disease progression or death from any cause, whichever occurs first, assessed up to 24 months.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~time from the date of randomization until disease progression or death from any cause, whichever occurs first, assessed up to 24 months.

This trial's timeline: 3 weeks for screening, Varies for treatment, and time from the date of randomization until disease progression or death from any cause, whichever occurs first, assessed up to 24 months. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Progression-free survival (PFS) in Cohort A

Progression-free survival (PFS) in Cohort B

POPLAR-NF2 Trial Design

5Treatment groups

Experimental Treatment

Placebo Group

Group I: Cohort B ActiveExperimental Treatment1 Intervention

Dose TBD

Group II: Cohort A Adults, Dose 60 mgExperimental Treatment1 Intervention

Group III: Cohort A Adults, Dose 40 mgExperimental Treatment1 Intervention

Group IV: Cohort A AdolescentsExperimental Treatment1 Intervention

Starting dose of 30 mg followed by dose escalation to 40 mg and 60 mg.

Group V: Cohort B PlaceboPlacebo Group1 Intervention

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Recursion Pharmaceuticals Inc.Lead Sponsor

3 Previous Clinical Trials

195 Total Patients Enrolled

Media Library

Placebo (Placebo) Clinical Trial Eligibility Overview. Trial Name: NCT05130866 — Phase 2 & 3

Neurofibromatosis Research Study Groups: Cohort A Adults, Dose 40 mg, Cohort A Adolescents, Cohort B Active, Cohort B Placebo, Cohort A Adults, Dose 60 mg

Neurofibromatosis Clinical Trial 2023: Placebo Highlights & Side Effects. Trial Name: NCT05130866 — Phase 2 & 3

Placebo (Placebo) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05130866 — Phase 2 & 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has this type of experiment been done before?

"REC-2282 was first studied in 2022 by Recursion Pharmaceuticals Inc. The first clinical trial completed in that year and involved 89 patients. After that, REC-2282 went through Phase 2 & 3 drug approval. There is now a single active study relating to REC-2282."

Answered by AI

Are there other existing papers that mention REC-2282?

"There is currently one Phase 3 clinical trial underway for REC-2282 with active sites in 12 locations across the United States, with the majority being in Dallas, Texas."

Answered by AI

What is the total number of research centers participating in this trial?

"There are a dozen enrolling sites for this trial, for example House Institute in Los Angeles, Children's National Hospital in Washington, and University of California Los Angeles in Gainesville."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Efficacy and Safety of REC-2282 in Patients With Progressive Neurofibromatosis Type 2 (NF2) Mutated Meningiomas

2022. "Efficacy and Safety of REC-2282 in Patients With Progressive Neurofibromatosis Type 2 (NF2) Mutated Meningiomas". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05130866.

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