Efficacy and Safety of REC-2282 in Patients With Progressive Neurofibromatosis Type 2 (NF2) Mutated Meningiomas (POPLAR-NF2)
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| ClinicalTrials.gov Identifier: NCT05130866 |
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Recruitment Status :
Recruiting
First Posted : November 23, 2021
Last Update Posted : August 22, 2023
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Sponsor:
Recursion Pharmaceuticals Inc.
Information provided by (Responsible Party):
Recursion Pharmaceuticals Inc.
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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 |
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.
| 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 |
| Actual Study Start Date : | June 20, 2022 |
| Estimated Primary Completion Date : | January 2027 |
| Estimated Study Completion Date : | July 2027 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Neurofibromatosis
| 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:
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| 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:
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Experimental: Cohort A Adolescents
Starting dose of 30 mg followed by dose escalation to 40 mg and 60 mg.
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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:
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Experimental: Cohort B Active
Dose TBD
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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:
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| 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 :
- 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
- 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.
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| Ages Eligible for Study: | 12 Years and older (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- ≥12 years of age and weighing at least 40 kg
- Progressive meningioma that is amenable to volumetric analysis
- 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)
- Adequate bone marrow function
- Has provided written informed consent/assent to participate in the study
Exclusion Criteria:
- Progressive disease associated with significant or disabling clinical symptoms likely to require surgery or radiation therapy within the next 3 months.
- 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.
- Received an anti- tumor agent for meningioma within 3 months, or 5 half-lives (whichever is longer), prior to screening.
- 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.
- Received another investigational drug within 30 days prior to screening
- 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
| Contact: Recursion Pharmaceuticals | 385-374-1724 | clinicaltrials@recursionpharma.com |
Locations
| United States, California | |
| House Institute | Recruiting |
| Los Angeles, California, United States, 90057 | |
| Contact: Kristina Bolt 213-459-5712 kbolt@hifla.org | |
| University of California Los Angeles | Recruiting |
| Los Angeles, California, United States, 90095 | |
| Contact: Savanah Wiles 310-825-5321 shwiles@mednet.ucla.edu | |
| Contact: Quan Li Quanli@mednet.ucla.edu | |
| United States, District of Columbia | |
| Children's National Hospital | Recruiting |
| Washington, District of Columbia, United States, 20010 | |
| Contact: Elizabeth Krisanda 202-476-6551 ekrisanda@childrensnational.org | |
| United States, Florida | |
| University of Florida | Recruiting |
| Gainesville, Florida, United States, 32611 | |
| Contact: Julie Segura 352-273-5550 julie.segura@neurology.ufl.edu | |
| Nicklaus Children's Hospital | Recruiting |
| Miami, Florida, United States, 33155 | |
| Contact: Jenny Esteves 786-624-2854 jenny.esteves@nicklaushealth.org | |
| United States, Kansas | |
| Sarah Cannon Cancer Institute - HCA Midwest | Recruiting |
| Overland Park, Kansas, United States, 66211 | |
| Contact: Megan Werner 816-276-3852 Megan.Werner@hcamidwest.com | |
| 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 | Recruiting |
| Boston, Massachusetts, United States, 02215 | |
| Contact: Mary Ellen Bowers 617-667-7000 mbowers@bidmc.harvard.edu | |
| United States, Minnesota | |
| University of Minnesota / Masonic Cancer Center | Recruiting |
| Minneapolis, Minnesota, United States, 55455 | |
| Contact: Allison Fullenkamp 612-625-6125 fulle631@umn.edu | |
| Contact: Christopher L Moertel, MD 651-247-0445 moert001@umn.edu | |
| Mayo Clinic | Recruiting |
| Rochester, Minnesota, United States, 55905 | |
| Contact: Grace Botzo 507-266-9415 botzo.grace@mayo.edu | |
| United States, New York | |
| Memorial Sloan Kettering Cancer Center | Recruiting |
| New York, New York, United States, 10065 | |
| Contact: Kristen Gary 866-886-9807 GaryK@mskcc.org | |
| United States, North Carolina | |
| Duke University Medical Center | Recruiting |
| Durham, North Carolina, United States, 27710 | |
| Contact: Sarah Woodring 919-684-2527 sarah.woodring@duke.edu | |
| United States, Texas | |
| UT Southwestern Medical Center | Recruiting |
| Dallas, Texas, United States, 75390 | |
| Contact: Dreaux Abe 214-456-6439 dreaux.abe@childrens.com | |
| Contact: Laura Klesse, MD, PhD 214-648-3122 Laura.Klesse@UTSouthwestern.edu | |
Sponsors and Collaborators
Recursion Pharmaceuticals Inc.
| 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: | August 22, 2023 |
| Last Verified: | March 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Recursion Pharmaceuticals Inc.:
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Neurofibromatosis Type 2; Neurofibromatosis Type II |
Additional relevant MeSH terms:
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Neuroendocrine Tumors 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 Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neuroma Vestibulocochlear Nerve Diseases |