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    DRUG:

    gedatolisib (PF-05212384)

    i
    Company:
    Celcuity, Pfizer
    Drug class:
    mTOR inhibitor, PI3K inhibitor
    Related drugs:
    Apply
    Phase 3 Study of Gedatolisib as First-Line Treatment for Patients With HR-Positive, HER2-Negative Advanced Breast Cancer (VIKTORIA-2) (NCT06757634)
    Phase 3
    Celcuity Inc
    Not yet recruiting
    Last update posted :
    01/07/2025
    Initiation :
    06/30/2025
    Primary completion :
    12/31/2027
    Completion :
    12/30/2028
    PIK3CA
    |
    Ibrance (palbociclib) • Kisqali (ribociclib) • fulvestrant • gedatolisib (PF-05212384)
    Gedatolisib Plus Talazoparib in Advanced Triple Negative or BRCA1/2 Positive, HER2 Negative Breast Cancers (BTCRC-BRE18-337) (NCT03911973)
    Phase 1/2
    Kari Wisinski
    Active, not recruiting
    Last update posted :
    06/07/2024
    Initiation :
    04/17/2019
    Primary completion :
    07/01/2024
    Completion :
    07/01/2024
    HER-2 • BRCA1 • BRCA2 • BRCA
    |
    HER-2 negative • BRCA1 negative
    |
    Talzenna (talazoparib) • gedatolisib (PF-05212384)
    Study of the CDK4/6 Inhibitor Palbociclib (PD-0332991) in Combination With the PI3K/mTOR Inhibitor Gedatolisib (PF-05212384) for Patients With Advanced Squamous Cell Lung, Pancreatic, Head & Neck and Other Solid Tumors (NCT03065062)
    Phase 1
    Dana-Farber Cancer Institute
    Recruiting
    Last update posted :
    02/06/2024
    Initiation :
    02/28/2017
    Primary completion :
    01/01/2025
    Completion :
    01/01/2026
    PIK3CA • PTEN
    |
    PIK3CA mutation
    |
    Ibrance (palbociclib) • gedatolisib (PF-05212384)
    Gedatolisib Plus Fulvestrant With or Without Palbociclib vs Standard-of-Care for the Treatment of Patients With Advanced or Metastatic HR+/HER2- Breast Cancer (VIKTORIA-1) (NCT05501886)
    Phase 3
    Celcuity, Inc.
    Recruiting
    Last update posted :
    08/01/2023
    Initiation :
    09/30/2022
    Primary completion :
    09/30/2024
    Completion :
    09/30/2026
    HER-2 • ER • PIK3CA • PGR
    |
    ER positive • PIK3CA mutation • PGR positive
    |
    Ibrance (palbociclib) • Piqray (alpelisib) • fulvestrant • gedatolisib (PF-05212384)
    A Study Of PF-05212384 In Combination With Other Anti-Tumor Agents and in Combination With Cisplatin in Patients With Triple Negative Breast Cancer in an Expansion Arm (TNBC) (NCT01920061)
    Phase 1b
    Pfizer
    Completed
    Last update posted :
    09/13/2022
    Initiation :
    09/10/2013
    Primary completion :
    01/08/2020
    Completion :
    01/08/2020
    HER-2 • KRAS • BRAF
    |
    BRAF V600E • KRAS mutation • BRAF mutation
    |
    cisplatin • docetaxel • Vizimpro (dacomitinib) • gedatolisib (PF-05212384)
    Gedatolisib Plus Fulvestrant With or Without Palbociclib vs Standard-of-Care for the Treatment of Patients With Advanced or Metastatic HR+/HER2- Breast Cancer (VIKTORIA-1) (NCT05486143)
    Phase 3
    Celcuity, Inc.
    Recruiting
    Last update posted :
    08/03/2022
    Initiation :
    09/30/2022
    Primary completion :
    09/30/2025
    Completion :
    09/30/2026
    HER-2 • ER • PIK3CA • PGR
    |
    ER positive • PIK3CA mutation • PGR positive
    |
    Ibrance (palbociclib) • Piqray (alpelisib) • fulvestrant • gedatolisib (PF-05212384)
    A Study To Assess The Tolerability And Clinical Activity Of Gedatolisib In Combination With Palbociclib/Letrozole Or Palbociclib/Fulvestrant In Women With Metastatic Breast Cancer (B2151009) (NCT02684032)
    Phase 1b
    Celcuity, Inc.
    Completed
    Last update posted :
    07/27/2022
    Initiation :
    06/14/2016
    Primary completion :
    01/19/2022
    Completion :
    01/19/2022
    HER-2 • ER
    |
    ER positive • HER-2 negative
    |
    Ibrance (palbociclib) • fulvestrant • letrozole • gedatolisib (PF-05212384)
    Phase I Study of Combination of Gedatolisib With Palbociclib and Faslodex in Patients With ER+/HER2- Breast Cancer (NCT02626507)
    Phase 1
    Hoffman Oncology
    Active, not recruiting
    Last update posted :
    02/09/2022
    Initiation :
    01/01/2016
    Primary completion :
    02/15/2022
    Completion :
    03/15/2022
    HER-2 • ER
    |
    HER-2 negative
    |
    Ibrance (palbociclib) • fulvestrant • gedatolisib (PF-05212384) • goserelin acetate
    Phase II Study of Herzuma® Plus Gedatolisib in Patients With HER-2 Positive Metastatic Breast Cancer (KCSG-BR18-13) (NCT03698383)
    Phase 2
    Korean Cancer Study Group
    Recruiting
    Last update posted :
    02/18/2021
    Initiation :
    12/03/2019
    Primary completion :
    10/01/2021
    Completion :
    12/01/2021
    PIK3CA • PTEN • mTOR
    |
    HER-2 positive • PIK3CA mutation • MTOR mutation
    |
    gedatolisib (PF-05212384) • Herzuma (trastuzumab-pkrb)
    An Initial Safety Study of Gedatolisib Plus PTK7-ADC for Metastatic Triple-negative Breast Cancer (NCT03243331)
    Phase 1
    Kathy Miller
    Completed
    Last update posted :
    01/07/2021
    Initiation :
    01/19/2018
    Primary completion :
    05/27/2020
    Completion :
    05/27/2020
    PTK7
    |
    gedatolisib (PF-05212384) • cofetuzumab pelidotin (ABBV-647)
    Gedatolisib, Hydroxychloroquine or the Combination for Prevention of Recurrent Breast Cancer ("GLACIER") (NCT03400254)
    Phase 1/2
    Abramson Cancer Center of the University of Pen...
    Withdrawn
    Last update posted :
    04/28/2020
    Initiation :
    02/26/2019
    Primary completion :
    08/30/2019
    Completion :
    11/12/2019
    HER-2 • ER • PGR
    |
    HER-2 negative
    |
    gedatolisib (PF-05212384) • hydroxychloroquine