TERMINATED

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

Conditions

Neurofibromatosis Type 2 Neurofibromatosis Type 2; Neurofibromatosis Type II

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a two-staged, Phase 2/3, randomized, multi-center study to investigate the efficacy and safety of REC-2282 in participants with progressive NF2 mutated meningiomas.

Official 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

Quick Facts

Study Start:2022-06-20

Study Completion:2025-08-18

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:TERMINATED

Study ID

NCT05130866

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:12 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. ≥12 years of age and weighing at least 40 kg 2. Progressive meningioma that is amenable to volumetric analysis 3. 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) 4. Adequate bone marrow function 5. Has provided written informed consent/assent to participate in the study	1. Progressive disease associated with significant or disabling clinical symptoms likely to require surgery or radiation therapy within the next 3 months. 2. Received prior surgery, radiosurgery, or laser interstitial thermal therapy in the target tumor, or immediately adjacent to the target tumor within 12 months prior to screening. 3. Received an anti- tumor agent for meningioma within 3 months, or 5 half-lives (whichever is longer), prior to screening. 4. History of an active malignancy within the previous 3 years except for localized cancers that are considered cured, and, in the opinion of the investigator, present a low risk of recurrence. 5. Received another investigational drug within 30 days prior to screening 6. Pregnant, lactating, or is planning to attempt to become pregnant or impregnate someone during this study or within 90 days after the last dosing cycle.

Inclusion Criteria

Exclusion Criteria

1. ≥12 years of age and weighing at least 40 kg
2. Progressive meningioma that is amenable to volumetric analysis
3. 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)
4. Adequate bone marrow function
5. Has provided written informed consent/assent to participate in the study

1. Progressive disease associated with significant or disabling clinical symptoms likely to require surgery or radiation therapy within the next 3 months.
2. Received prior surgery, radiosurgery, or laser interstitial thermal therapy in the target tumor, or immediately adjacent to the target tumor within 12 months prior to screening.
3. Received an anti- tumor agent for meningioma within 3 months, or 5 half-lives (whichever is longer), prior to screening.
4. History of an active malignancy within the previous 3 years except for localized cancers that are considered cured, and, in the opinion of the investigator, present a low risk of recurrence.
5. Received another investigational drug within 30 days prior to screening
6. Pregnant, lactating, or is planning to attempt to become pregnant or impregnate someone during this study or within 90 days after the last dosing cycle.

Contacts and Locations

Study Locations (Sites)

House Institute

Los Angeles, California, 90057

United States

University of California Los Angeles

Los Angeles, California, 90095

United States

Children's National Hospital

Washington D.C., District of Columbia, 20010

United States

University of Florida

Gainesville, Florida, 32611

United States

Nicklaus Children's Hospital

Miami, Florida, 33155

United States

Sarah Cannon Cancer Institute - HCA Midwest

Overland Park, Kansas, 66211

United States

Massachusetts General Hospital

Boston, Massachusetts, 02114

United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215

United States

University of Minnesota / Masonic Cancer Center

Minneapolis, Minnesota, 55455

United States

Mayo Clinic

Rochester, Minnesota, 55905

United States

Columbia University

New York, New York, 10032

United States

Memorial Sloan Kettering Cancer Center

New York, New York, 10065

United States

Duke University Medical Center

Durham, North Carolina, 27710

United States

UT Southwestern Medical Center

Dallas, Texas, 75390

United States

Collaborators and Investigators

Sponsor: Recursion Pharmaceuticals Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-06-20

Study Completion Date2025-08-18

Study Record Updates

Study Start Date2022-06-20

Study Completion Date2025-08-18

Terms related to this study

Keywords Provided by Researchers

Neurofibromatosis Type 2; Neurofibromatosis Type II

Additional Relevant MeSH Terms

Neurofibromatosis Type 2