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    DRUG:

    Ogsiveo (nirogacestat)

    i
    Other names: PF-03084014 , PF03084014, PF 03084014
    Company:
    EMD Serono
    Drug class:
    γ-secretase inhibitor
    Related drugs:
    10d
    NIR-DT-106: Phase 1 Study to Determine the Effect of CYP Induction Following Administration of Nirogacestat in Healthy Men Participants (2025-521402-18-00)
    P1, N=16, Active, not recruiting, Springworks Therapeutics Inc. | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    Ogsiveo (nirogacestat)
    12d
    MagnetisMM-4: Umbrella Study of Elranatamab (PF-06863135) in Combination With Anti-Cancer Treatments in Multiple Myeloma (clinicaltrials.gov)
    P2, N=46, Active, not recruiting, Pfizer | N=34 --> 46
    Enrollment change
    |
    lenalidomide • dexamethasone • Elrexfio (elranatamab-bcmm) • Ogsiveo (nirogacestat)
    17d
    NIR-DT-401: An Open-label, Phase 4 Study of Nirogacestat in Adult Premenopausal Females with Desmoid Tumor/Aggressive Fibromatosis (DT/AF). (2024-515215-21-00)
    P4, N=47, Recruiting, Springworks Therapeutics Inc.
    New P4 trial
    |
    Ogsiveo (nirogacestat)
    17d
    NIR-DT-106: Phase 1 Study to Determine the Effect of CYP Induction Following Administration of Nirogacestat in Healthy Men Participants (2025-521402-18-00)
    P1, N=16, Recruiting, Springworks Therapeutics Inc.
    New P1 trial
    |
    Ogsiveo (nirogacestat)
    1m
    A Study of a New Drug, Nirogacestat, for Treating Desmoid Tumors That Cannot be Removed by Surgery (clinicaltrials.gov)
    P2, N=35, Active, not recruiting, Children's Oncology Group | Trial completion date: Mar 2026 --> Dec 2032
    Trial completion date
    |
    CTNNB1 (Catenin (cadherin-associated protein), beta 1)
    |
    Ogsiveo (nirogacestat)
    2ms
    Phase II clinical trial of nirogacestat in patients with relapsed ovarian granulosa cell tumours. (PubMed, Clin Transl Med)
    This Phase II clinical trial of a rare tumour achieved its enrolment target in under 1 year and completed primary analysis within 2 years. 87% (46 of 53 patients who received nirogacestat) had fresh or archival biopsies that were analysed by next-generation sequencing for mutational profiling. Of the 3 patients with activating NOTCH1 mutations, all achieved 6-month progression-free survival (PFS6); 8 other patients also achieved PFS6 but did not share a common mutation.
    P2 data • Journal
    |
    NOTCH1 (Notch 1) • NOTCH2 (Notch 2) • NOTCH3 (Notch Receptor 3) • FOXL2 (Forkhead Box L2)
    |
    Ogsiveo (nirogacestat)
    3ms
    NIR-OGT-201: Nirogacestat in Ovarian Granulosa Cell Tumors (clinicaltrials.gov)
    P2, N=53, Completed, SpringWorks Therapeutics, Inc. | Active, not recruiting --> Completed | Trial completion date: Dec 2027 --> Jul 2025 | Trial primary completion date: Jul 2026 --> Jul 2025
    Trial completion • Trial completion date • Trial primary completion date
    |
    Ogsiveo (nirogacestat)
    3ms
    To Determine the Effect of CYP Induction Following Administration of Nirogacestat in Healthy Adult Male Participants (clinicaltrials.gov)
    P1, N=16, Recruiting, SpringWorks Therapeutics, Inc.
    New P1 trial
    |
    Ogsiveo (nirogacestat) • midazolam hydrochloride • omeprazole
    3ms
    A Study of a New Drug, Nirogacestat, for Treating Desmoid Tumors That Cannot be Removed by Surgery (clinicaltrials.gov)
    P2, N=35, Active, not recruiting, Children's Oncology Group | Trial completion date: Dec 2025 --> Mar 2026 | Trial primary completion date: Dec 2025 --> Mar 2026
    Trial completion date • Trial primary completion date
    |
    CTNNB1 (Catenin (cadherin-associated protein), beta 1)
    |
    Ogsiveo (nirogacestat)
    4ms
    DREAMM 5: Platform Study of Belantamab Mafodotin as Monotherapy and in Combination With Anti-cancer Treatments in Participants With Relapsed/Refractory Multiple Myeloma (RRMM) (clinicaltrials.gov)
    P2, N=208, Active, not recruiting, GlaxoSmithKline | Trial completion date: Feb 2029 --> Mar 2027 | Trial primary completion date: Feb 2029 --> Apr 2025
    Trial completion date • Trial primary completion date
    |
    lenalidomide • Jemperli (dostarlimab-gxly) • dexamethasone • pomalidomide • Sarclisa (isatuximab-irfc) • Blenrep (belantamab mafodotin-blmf) • Ogsiveo (nirogacestat) • feladilimab (GSK3359609) • GSK3174998
    5ms
    A Study of a New Drug, Nirogacestat, for Treating Desmoid Tumors That Cannot be Removed by Surgery (clinicaltrials.gov)
    P2, N=35, Active, not recruiting, Children's Oncology Group | Trial completion date: Sep 2025 --> Dec 2025 | Trial primary completion date: Sep 2025 --> Dec 2025
    Trial completion date • Trial primary completion date
    |
    CTNNB1 (Catenin (cadherin-associated protein), beta 1)
    |
    Ogsiveo (nirogacestat)
    5ms
    MajesTEC-2: A Study of Teclistamab With Other Anticancer Therapies in Participants With Multiple Myeloma (clinicaltrials.gov)
    P1, N=140, Active, not recruiting, Janssen Research & Development, LLC | Trial completion date: Apr 2027 --> Oct 2027
    Trial completion date
    |
    lenalidomide • bortezomib • Darzalex (daratumumab) • pomalidomide • Ogsiveo (nirogacestat) • Tecvayli (teclistamab-cqyv)