Ignite Creation Date:
2025-12-24 @ 4:41 PM
Ignite Modification Date:
2025-12-27 @ 12:43 AM
Study NCT ID:
NCT05130866
Status:
TERMINATED
Last Update Posted:
2025-10-07
First Post:
2021-11-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of REC-2282 in Patients With Progressive Neurofibromatosis Type 2 (NF2) Mutated Meningiomas
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016518', 'term': 'Neurofibromatosis 2'}], 'ancestors': [{'id': 'D009464', 'term': 'Neuroma, Acoustic'}, {'id': 'D009442', 'term': 'Neurilemmoma'}, {'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D017253', 'term': 'Neurofibromatoses'}, {'id': 'D009455', 'term': 'Neurofibroma'}, {'id': 'D018317', 'term': 'Nerve Sheath Neoplasms'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D009463', 'term': 'Neuroma'}, {'id': 'D009386', 'term': 'Neoplastic Syndromes, Hereditary'}, {'id': 'D000160', 'term': 'Vestibulocochlear Nerve Diseases'}, {'id': 'D012181', 'term': 'Retrocochlear Diseases'}, {'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D010039', 'term': 'Otorhinolaryngologic Neoplasms'}, {'id': 'D003390', 'term': 'Cranial Nerve Neoplasms'}, {'id': 'D003389', 'term': 'Cranial Nerve Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020752', 'term': 'Neurocutaneous Syndromes'}, {'id': 'D020271', 'term': 'Heredodegenerative Disorders, Nervous System'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C524513', 'term': 'HDAC-42'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Masking applies to Cohort B only.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A Two-staged, Phase 2/3, Randomized, Multicenter Efficacy and Safety Study.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'whyStopped': 'Study was terminated due to sponsor decision. This decision was not related to safety concerns with REC-2282.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2022-06-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2025-08-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-10-01', 'studyFirstSubmitDate': '2021-11-10', 'studyFirstSubmitQcDate': '2021-11-19', 'lastUpdatePostDateStruct': {'date': '2025-10-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-11-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cohort A: Number of Participants with Progression-free survival (PFS) at 6 Months', 'timeFrame': '6 months', 'description': 'In Cohort A, PFS is defined as the number of participants who are alive and progression-free at 6 months with progression defined as having an increase of 20% or more in the target tumor identified.'}, {'measure': 'Cohort B: Number of Participants with PFS up to 3 years', 'timeFrame': 'Up to 3 years', 'description': 'In Cohort B, PFS is defined as the time from the date of randomization until disease progression or death from any cause, whichever occurs first.'}], 'secondaryOutcomes': [{'measure': 'Cohort A: Change from Baseline in Target Tumor Volume at 6 Months', 'timeFrame': '6 months'}, {'measure': 'Cohort A: Number of Participants with PFS at 12 and 24 Months', 'timeFrame': '12 and 24 Months', 'description': 'In Cohort A, PFS is defined as the number of participants who are alive and progression-free at 12 and 24 months with progression defined as having an increase of 20% or more in the target tumor identified.'}, {'measure': 'Cohorts A and B: Objective Response Rate (ORR)', 'timeFrame': 'Up to 3 years'}, {'measure': 'Cohorts A and B: Disease Control Rate (DCR)', 'timeFrame': 'Up to 3 years'}, {'measure': 'Cohorts A and B: Time to Response (TTR)', 'timeFrame': 'Up to 3 years'}, {'measure': 'Cohorts A and B: Duration of Response (DOR)', 'timeFrame': 'Up to 3 years'}, {'measure': 'Cohorts A and B: Time to Surgery/radiation for Target Tumors', 'timeFrame': 'Up to 3 years'}, {'measure': 'Cohorts A and B: Maximum Observed Plasma Concentration (Cmax) of REC-2282', 'timeFrame': 'Up to 3 years'}, {'measure': 'Cohorts A and B: Time to Maximum Plasma Concentration (Tmax) of REC-2282', 'timeFrame': 'Up to 3 years'}, {'measure': 'Cohorts A and B: Area under the curve from 0 to 24hr (AUC) of REC-2282', 'timeFrame': 'Predose to 24 hours postdose'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Neurofibromatosis Type 2; Neurofibromatosis Type II'], 'conditions': ['Neurofibromatosis Type 2']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'Cohort A (Phase 2) 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, Phase 3). 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.\n\nIn 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.\n\nIn Cohort A, adult participants will be randomized to one of two dose levels of REC-2282.\n\nIn 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. ≥12 years of age and weighing at least 40 kg\n2. Progressive meningioma that is amenable to volumetric analysis\n3. 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)\n4. Adequate bone marrow function\n5. Has provided written informed consent/assent to participate in the study\n\nExclusion Criteria:\n\n1. Progressive disease associated with significant or disabling clinical symptoms likely to require surgery or radiation therapy within the next 3 months.\n2. 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.\n3. Received an anti- tumor agent for meningioma within 3 months, or 5 half-lives (whichever is longer), prior to screening.\n4. 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.\n5. Received another investigational drug within 30 days prior to screening\n6. 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.'}, 'identificationModule': {'nctId': 'NCT05130866', 'acronym': 'POPLAR-NF2', 'briefTitle': 'Efficacy and Safety of REC-2282 in Patients With Progressive Neurofibromatosis Type 2 (NF2) Mutated Meningiomas', 'organization': {'class': 'INDUSTRY', 'fullName': 'Recursion Pharmaceuticals Inc.'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'REC-2282-201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort A Adults, REC-2282 40 mg', 'description': 'Adult participants will receive REC-2282.', 'interventionNames': ['Drug: REC-2282']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort A Adults, REC-2282 60 mg', 'description': 'Adult participants will receive REC-2282.', 'interventionNames': ['Drug: REC-2282']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort A Adolescents, REC-2282', 'description': 'Adolescent participants will receive REC-2282.', 'interventionNames': ['Drug: REC-2282']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort B REC-2282', 'description': 'Participants will receive REC-2282.', 'interventionNames': ['Drug: REC-2282']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Cohort B Placebo', 'description': 'Participants will receive placebo.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'REC-2282', 'type': 'DRUG', 'otherNames': ['AR-42', 'OSU-HDAC42', 'NSC-D736012'], 'description': 'Participants will receive REC-2282 3 times per week orally for 3 weeks followed by 1 week off for a 4-week cycle.', 'armGroupLabels': ['Cohort A Adolescents, REC-2282', 'Cohort A Adults, REC-2282 40 mg', 'Cohort A Adults, REC-2282 60 mg', 'Cohort B REC-2282']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Participants will receive placebo orally 3 times per week for 3 weeks followed by 1 week off for a 4-week cycle.', 'armGroupLabels': ['Cohort B Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90057', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'House Institute', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of California Los Angeles', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '20010', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': "Children's National Hospital", 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '32611', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '33155', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': "Nicklaus Children's Hospital", 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '66211', 'city': 'Overland Park', 'state': 'Kansas', 'country': 'United States', 'facility': 'Sarah Cannon Cancer Institute - HCA Midwest', 'geoPoint': {'lat': 38.98223, 'lon': -94.67079}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Beth Israel Deaconess Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'University of Minnesota / Masonic Cancer Center', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'UT Southwestern Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Recursion Pharmaceuticals Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}