Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05130866
Recruitment Status : Recruiting
First Posted : November 23, 2021
Last Update Posted : June 15, 2022
Sponsor:
Information provided by (Responsible Party):
Recursion Pharmaceuticals Inc.

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

Condition or disease Intervention/treatment Phase
Neurofibromatosis Type 2 Drug: REC-2282 Drug: Placebo Phase 2 Phase 3

Detailed Description:

This is a parallel-group, two-staged, Phase 2/3, randomized, multi-center study to investigate the efficacy and safety of REC-2282 in patients with progressive NF2 mutated meningiomas, with either NF2 disease-related meningioma or recurrent sporadic meningiomas that have NF2 mutations.

Cohort A will provide early data on efficacy and safety of REC-2282 in participants with progressive NF2 mutated meningiomas, and provide guidance for the dose in the confirmatory part of the study (Cohort B). The purpose of Cohort B of the study is to assess the efficacy and safety of REC-2282 compared with placebo in participants with progressive NF2 mutated meningiomas.

In both cohorts, there will be a screening period of up to 8 weeks, a treatment period, a 4-week safety follow-up period after the end of treatment, and a 6-month post-study follow-up. The first 8 participants enrolled in Cohort A will complete a food effect run-in sub study. At the end of the study period, participants may be offered participation in an open-label extension (OLE) period.

In Cohort A, adult participants will be randomized to one of two dose levels of REC-2282.

In Cohort B, participants will be randomized to REC-2282 treatment (dose to be determined from Cohort A) arm or placebo arm in a ratio of 2:1.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 89 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A Parallel-group, Two-staged, Phase 2/3, Randomized, Multicenter Efficacy and Safety Study.
Masking: Double (Participant, Investigator)
Masking Description: Masking applies to Cohort B only.
Primary Purpose: Treatment
Official 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
Estimated Study Start Date : June 2022
Estimated Primary Completion Date : January 2027
Estimated Study Completion Date : July 2027


Arm Intervention/treatment
Experimental: Cohort A Adults, Dose 40 mg Drug: REC-2282
Participants will receive REC-2282 3 times per week orally for 3 weeks followed by 1 week off for a 4-week cycle.
Other Names:
  • AR-42
  • OSU-HDAC42
  • NSC-D736012

Experimental: Cohort A Adults, Dose 60 mg Drug: REC-2282
Participants will receive REC-2282 3 times per week orally for 3 weeks followed by 1 week off for a 4-week cycle.
Other Names:
  • AR-42
  • OSU-HDAC42
  • NSC-D736012

Experimental: Cohort A Adolescents
Starting dose of 30 mg followed by dose escalation to 40 mg and 60 mg.
Drug: REC-2282
Participants will receive REC-2282 3 times per week orally for 3 weeks followed by 1 week off for a 4-week cycle.
Other Names:
  • AR-42
  • OSU-HDAC42
  • NSC-D736012

Experimental: Cohort B Active
Dose TBD
Drug: REC-2282
Participants will receive REC-2282 3 times per week orally for 3 weeks followed by 1 week off for a 4-week cycle.
Other Names:
  • AR-42
  • OSU-HDAC42
  • NSC-D736012

Placebo Comparator: Cohort B Placebo Drug: Placebo
Participants will receive placebo orally 3 times per week for 3 weeks followed by 1 week off for a 4-week cycle.




Primary Outcome Measures :
  1. Progression-free survival (PFS) in Cohort A [ Time Frame: 6 months ]
    The proportion of participants in Cohort A who are alive and progression-free after 6 cycles of treatment

  2. Progression-free survival (PFS) in Cohort B [ Time Frame: Time from the date of randomization until disease progression or death from any cause, whichever occurs first, assessed up to 24 months. ]
    In Cohort B, the time from the date of randomization until disease progression or death from any cause, whichever occurs first.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion 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

Exclusion Criteria:

  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 6 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 dose of IMP.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05130866


Contacts
Layout table for location contacts
Contact: Recursion Pharmaceuticals 385-374-1724 clinicaltrials@recursionpharma.com

Locations
Layout table for location information
United States, California
House Institute Not yet recruiting
Los Angeles, California, United States, 90057
University of California Los Angeles Not yet recruiting
Los Angeles, California, United States, 90095
United States, District of Columbia
Children's National Hospital Recruiting
Washington, District of Columbia, United States, 20010
United States, Florida
University of Florida Not yet recruiting
Gainesville, Florida, United States, 32611
United States, Kansas
Sarah Cannon Cancer Institute - HCA Midwest Not yet recruiting
Overland Park, Kansas, United States, 66211
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Lauren M Hibyan    617-643-8992    lmhibyan@partners.org   
Beth Israel Deaconess Medical Center Not yet recruiting
Boston, Massachusetts, United States, 02215
United States, Minnesota
University of Minnesota / Masonic Cancer Center Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Christopher L Moertel, MD    651-247-0445    moert001@umn.edu   
Mayo Clinic Not yet recruiting
Rochester, Minnesota, United States, 55905
United States, New York
Memorial Sloan Kettering Cancer Center Not yet recruiting
New York, New York, United States, 10065
United States, North Carolina
Duke University Medical Center Not yet recruiting
Durham, North Carolina, United States, 27710
Contact: Margaret O Johnson, MD, MPH         
United States, Texas
UT Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Contact: Laura Klesse, MD, PhD    214-648-3122    Laura.Klesse@UTSouthwestern.edu   
Sponsors and Collaborators
Recursion Pharmaceuticals Inc.
Layout table for additonal information
Responsible Party: Recursion Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT05130866    
Other Study ID Numbers: REC-2282-201
First Posted: November 23, 2021    Key Record Dates
Last Update Posted: June 15, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Recursion Pharmaceuticals Inc.:
Neurofibromatosis Type 2; Neurofibromatosis Type II
Additional relevant MeSH terms:
Layout table for MeSH terms
Meningioma
Neurofibromatoses
Neurofibromatosis 1
Neurofibroma
Neurofibromatosis 2
Neoplasms, Nerve Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Vascular Tissue
Meningeal Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Nervous System Diseases
Nerve Sheath Neoplasms
Neoplastic Syndromes, Hereditary
Neurocutaneous Syndromes
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Peripheral Nervous System Diseases
Neuromuscular Diseases
Peripheral Nervous System Neoplasms
Neuroma, Acoustic
Neurilemmoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neuroma
Vestibulocochlear Nerve Diseases