Efficacy and Safety of REC-2282 in Patients With Progressive Neurofibromatosis Type 2 (NF2) Mutated Meningiomas
Megadott ok: Study was terminated due to sponsor decision. This decision was not related to safety concerns with REC-2282.
A legfontosabb adatok
- Hol
- Boston, Dallas, Durham, Gainesville, Los Angeles, Miami, Minneapolis, New York, Overland Park, Rochester és Washington D.C. (Egyesült Államok)Mind a 14 helyszín megnézése
- Fázis
- 2/3. fázis
Helyszínek itt: Egyesült Államok
- Beth Israel Deaconess Medical CenterBoston, Egyesült ÁllamokNo longer taking part
- Massachusetts General HospitalBoston, Egyesült ÁllamokNo longer taking part
- UT Southwestern Medical CenterDallas, Egyesült ÁllamokNo longer taking part
- Duke University Medical CenterDurham, Egyesült ÁllamokNo longer taking part
- University of FloridaGainesville, Egyesült ÁllamokNo longer taking part
- House InstituteLos Angeles, Egyesült ÁllamokNo longer taking part
- University of California, Los AngelesLos Angeles, Egyesült ÁllamokNo longer taking part
- Nicklaus Children's HospitalMiami, Egyesült ÁllamokNo longer taking part
- University of Minnesota/Masonic Cancer CenterMinneapolis, Egyesült ÁllamokNo longer taking part
- Columbia UniversityNew York, Egyesült ÁllamokNo longer taking part
- Memorial Sloan-Kettering Cancer CenterNew York, Egyesült ÁllamokNo longer taking part
- Sarah Cannon Cancer Institute - HCA MidwestOverland Park, Egyesült ÁllamokNo longer taking part
- Mayo ClinicRochester, Egyesült ÁllamokNo longer taking part
- Children's National HospitalWashington D.C., Egyesült ÁllamokNo longer taking part
A vizsgálat adatai
- Ki végzi
- Recursion Pharmaceuticals Inc.
- Azonosító
- NCT05130866
- A regiszteradat frissítve
- 2026. augusztus 17.
- Eredeti leírás
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.A teljes eredeti leírásKevesebb
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
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.
Bevonási feltételek: ≥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.
Kizáró feltételek: 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; 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; Progressive disease associated with significant or disabling clinical symptoms likely to require surgery or radiation therapy within the next 3 months; 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.