[{"id":"fe616f09-6291-4f55-8056-8b008452edb9","acronym":"","url":"https://clinicaltrials.gov/study/NCT06757634","created_at":"2025-02-25T20:04:40.854Z","updated_at":"2025-02-25T20:04:40.854Z","phase":"Phase 3","brief_title":"Phase 3 Study of Gedatolisib as First-Line Treatment for Patients With HR-Positive, HER2-Negative Advanced Breast Cancer (VIKTORIA-2)","source_id_and_acronym":"NCT06757634","lead_sponsor":"Celcuity Inc","biomarkers":" PIK3CA","pipe":"","alterations":" ","tags":["PIK3CA"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e Ibrance (palbociclib) • Kisqali (ribociclib) • fulvestrant • gedatolisib (PF-05212384)"],"overall_status":"Not yet recruiting","enrollment":" Enrollment 674","initiation":"Initiation: 06/30/2025","start_date":" 06/30/2025","primary_txt":" Primary completion: 12/31/2027","primary_completion_date":" 12/31/2027","study_txt":" Completion: 12/30/2028","study_completion_date":" 12/30/2028","last_update_posted":"2025-01-07"},{"id":"6c1bf2f9-a643-4b80-84fa-1e32b26a8869","acronym":"BTCRC-BRE18-337","url":"https://clinicaltrials.gov/study/NCT03911973","created_at":"2021-01-18T19:15:11.647Z","updated_at":"2024-07-02T16:34:37.336Z","phase":"Phase 1/2","brief_title":"Gedatolisib Plus Talazoparib in Advanced Triple Negative or BRCA1/2 Positive, HER2 Negative Breast Cancers","source_id_and_acronym":"NCT03911973 - BTCRC-BRE18-337","lead_sponsor":"Kari Wisinski","biomarkers":" HER-2 • BRCA1 • BRCA2 • BRCA","pipe":" | ","alterations":" HER-2 negative • BRCA1 negative","tags":["HER-2 • BRCA1 • BRCA2 • BRCA"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e HER-2 negative • BRCA1 negative"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e Talzenna (talazoparib) • gedatolisib (PF-05212384)"],"overall_status":"Active, not recruiting","enrollment":" Enrollment 37","initiation":"Initiation: 04/17/2019","start_date":" 04/17/2019","primary_txt":" Primary completion: 07/01/2024","primary_completion_date":" 07/01/2024","study_txt":" Completion: 07/01/2024","study_completion_date":" 07/01/2024","last_update_posted":"2024-06-07"},{"id":"0a5c6ecb-6e8b-4c37-8a56-4472e94bb344","acronym":"","url":"https://clinicaltrials.gov/study/NCT03065062","created_at":"2021-01-18T15:05:53.427Z","updated_at":"2024-07-02T16:35:20.735Z","phase":"Phase 1","brief_title":"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 \u0026 Neck and Other Solid Tumors","source_id_and_acronym":"NCT03065062","lead_sponsor":"Dana-Farber Cancer Institute","biomarkers":" PIK3CA • PTEN","pipe":" | ","alterations":" PIK3CA mutation","tags":["PIK3CA • PTEN"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e PIK3CA mutation"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e Ibrance (palbociclib) • gedatolisib (PF-05212384)"],"overall_status":"Recruiting","enrollment":" Enrollment 96","initiation":"Initiation: 02/28/2017","start_date":" 02/28/2017","primary_txt":" Primary completion: 01/01/2025","primary_completion_date":" 01/01/2025","study_txt":" Completion: 01/01/2026","study_completion_date":" 01/01/2026","last_update_posted":"2024-02-06"},{"id":"d2a1f497-dc00-456c-bc4d-27ca055c9d89","acronym":"VIKTORIA-1","url":"https://clinicaltrials.gov/study/NCT05501886","created_at":"2022-08-16T12:57:45.738Z","updated_at":"2024-07-02T16:35:41.507Z","phase":"Phase 3","brief_title":"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)","source_id_and_acronym":"NCT05501886 - VIKTORIA-1","lead_sponsor":"Celcuity, Inc.","biomarkers":" HER-2 • ER • PIK3CA • PGR","pipe":" | ","alterations":" ER positive • PIK3CA mutation • PGR positive","tags":["HER-2 • ER • PIK3CA • PGR"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e ER positive • PIK3CA mutation • PGR positive"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e Ibrance (palbociclib) • Piqray (alpelisib) • fulvestrant • gedatolisib (PF-05212384)"],"overall_status":"Recruiting","enrollment":" Enrollment 701","initiation":"Initiation: 09/30/2022","start_date":" 09/30/2022","primary_txt":" Primary completion: 09/30/2024","primary_completion_date":" 09/30/2024","study_txt":" Completion: 09/30/2026","study_completion_date":" 09/30/2026","last_update_posted":"2023-08-01"},{"id":"49cd925d-5478-4371-b4b0-a086d238accc","acronym":"","url":"https://clinicaltrials.gov/study/NCT01920061","created_at":"2021-01-18T08:39:47.248Z","updated_at":"2024-07-02T16:36:04.030Z","phase":"Phase 1b","brief_title":"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)","source_id_and_acronym":"NCT01920061","lead_sponsor":"Pfizer","biomarkers":" HER-2 • KRAS • BRAF","pipe":" | ","alterations":" BRAF V600E • KRAS mutation • BRAF mutation","tags":["HER-2 • KRAS • BRAF"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e BRAF V600E • KRAS mutation • BRAF mutation"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e cisplatin • docetaxel • Vizimpro (dacomitinib) • gedatolisib (PF-05212384)"],"overall_status":"Completed","enrollment":" Enrollment 110","initiation":"Initiation: 09/10/2013","start_date":" 09/10/2013","primary_txt":" Primary completion: 01/08/2020","primary_completion_date":" 01/08/2020","study_txt":" Completion: 01/08/2020","study_completion_date":" 01/08/2020","last_update_posted":"2022-09-13"},{"id":"f528e44c-c0ff-4562-9478-599f9db53b2a","acronym":"VIKTORIA-1","url":"https://clinicaltrials.gov/study/NCT05486143","created_at":"2022-08-03T15:55:05.186Z","updated_at":"2025-02-25T20:04:04.784Z","phase":"Phase 3","brief_title":"Gedatolisib Plus Fulvestrant With or Without Palbociclib vs Standard-of-Care for the Treatment of Patients With Advanced or Metastatic HR+/HER2- Breast Cancer","source_id_and_acronym":"NCT05486143 - VIKTORIA-1","lead_sponsor":"Celcuity, Inc.","biomarkers":" HER-2 • ER • PIK3CA • PGR","pipe":" | ","alterations":" ER positive • PIK3CA mutation • PGR positive","tags":["HER-2 • ER • PIK3CA • PGR"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e ER positive • PIK3CA mutation • PGR positive"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e Ibrance (palbociclib) • Piqray (alpelisib) • fulvestrant • gedatolisib (PF-05212384)"],"overall_status":"Recruiting","enrollment":" Enrollment 701","initiation":"Initiation: 09/30/2022","start_date":" 09/30/2022","primary_txt":" Primary completion: 09/30/2025","primary_completion_date":" 09/30/2025","study_txt":" Completion: 09/30/2026","study_completion_date":" 09/30/2026","last_update_posted":"2022-08-03"},{"id":"c65cf06e-76c6-4405-9194-76740d9fdfff","acronym":"B2151009","url":"https://clinicaltrials.gov/study/NCT02684032","created_at":"2021-01-17T17:24:35.057Z","updated_at":"2024-07-02T16:36:06.521Z","phase":"Phase 1b","brief_title":"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","source_id_and_acronym":"NCT02684032 - B2151009","lead_sponsor":"Celcuity, Inc.","biomarkers":" HER-2 • ER","pipe":" | ","alterations":" ER positive • HER-2 negative","tags":["HER-2 • ER"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e ER positive • HER-2 negative"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e Ibrance (palbociclib) • fulvestrant • letrozole • gedatolisib (PF-05212384)"],"overall_status":"Completed","enrollment":" Enrollment 141","initiation":"Initiation: 06/14/2016","start_date":" 06/14/2016","primary_txt":" Primary completion: 01/19/2022","primary_completion_date":" 01/19/2022","study_txt":" Completion: 01/19/2022","study_completion_date":" 01/19/2022","last_update_posted":"2022-07-27"},{"id":"e86355f5-bbcf-4d10-89bf-8a9a9cccffcc","acronym":"","url":"https://clinicaltrials.gov/study/NCT02626507","created_at":"2021-01-18T12:45:54.371Z","updated_at":"2024-07-02T16:36:17.340Z","phase":"Phase 1","brief_title":"Phase I Study of Combination of Gedatolisib With Palbociclib and Faslodex in Patients With ER+/HER2- Breast Cancer","source_id_and_acronym":"NCT02626507","lead_sponsor":"Hoffman Oncology","biomarkers":" HER-2 • ER","pipe":" | ","alterations":" HER-2 negative","tags":["HER-2 • ER"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e HER-2 negative"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e Ibrance (palbociclib) • fulvestrant • gedatolisib (PF-05212384) • goserelin acetate"],"overall_status":"Active, not recruiting","enrollment":" Enrollment 18","initiation":"Initiation: 01/01/2016","start_date":" 01/01/2016","primary_txt":" Primary completion: 02/15/2022","primary_completion_date":" 02/15/2022","study_txt":" Completion: 03/15/2022","study_completion_date":" 03/15/2022","last_update_posted":"2022-02-09"},{"id":"9e574470-b55c-4fb9-ba76-d1930189d237","acronym":"KCSG-BR18-13","url":"https://clinicaltrials.gov/study/NCT03698383","created_at":"2021-01-18T18:07:34.589Z","updated_at":"2024-07-02T16:36:34.376Z","phase":"Phase 2","brief_title":"Phase II Study of Herzuma® Plus Gedatolisib in Patients With HER-2 Positive Metastatic Breast Cancer","source_id_and_acronym":"NCT03698383 - KCSG-BR18-13","lead_sponsor":"Korean Cancer Study Group","biomarkers":" PIK3CA • PTEN • mTOR","pipe":" | ","alterations":" HER-2 positive • PIK3CA mutation • MTOR mutation","tags":["PIK3CA • PTEN • mTOR"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e HER-2 positive • PIK3CA mutation • MTOR mutation"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e gedatolisib (PF-05212384) • Herzuma (trastuzumab-pkrb)"],"overall_status":"Recruiting","enrollment":" Enrollment 15","initiation":"Initiation: 12/03/2019","start_date":" 12/03/2019","primary_txt":" Primary completion: 10/01/2021","primary_completion_date":" 10/01/2021","study_txt":" Completion: 12/01/2021","study_completion_date":" 12/01/2021","last_update_posted":"2021-02-18"},{"id":"57d6881f-b23a-4f7f-be7a-a09460786ee4","acronym":"","url":"https://clinicaltrials.gov/study/NCT03243331","created_at":"2023-04-19T23:04:29.355Z","updated_at":"2024-07-02T16:36:36.501Z","phase":"Phase 1","brief_title":"An Initial Safety Study of Gedatolisib Plus PTK7-ADC for Metastatic Triple-negative Breast Cancer","source_id_and_acronym":"NCT03243331","lead_sponsor":"Kathy Miller","biomarkers":" PTK7","pipe":"","alterations":" ","tags":["PTK7"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e gedatolisib (PF-05212384) • cofetuzumab pelidotin (ABBV-647)"],"overall_status":"Completed","enrollment":" Enrollment 18","initiation":"Initiation: 01/19/2018","start_date":" 01/19/2018","primary_txt":" Primary completion: 05/27/2020","primary_completion_date":" 05/27/2020","study_txt":" Completion: 05/27/2020","study_completion_date":" 05/27/2020","last_update_posted":"2021-01-07"},{"id":"931b5967-3a2b-451b-b8e1-f8c957662479","acronym":"GLACIER","url":"https://clinicaltrials.gov/study/NCT03400254","created_at":"2021-01-18T16:46:51.444Z","updated_at":"2024-07-02T16:36:45.588Z","phase":"Phase 1/2","brief_title":"Gedatolisib, Hydroxychloroquine or the Combination for Prevention of Recurrent Breast Cancer (\"GLACIER\")","source_id_and_acronym":"NCT03400254 - GLACIER","lead_sponsor":"Abramson Cancer Center of the University of Pennsylvania","biomarkers":" HER-2 • ER • PGR","pipe":" | ","alterations":" HER-2 negative","tags":["HER-2 • ER • PGR"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e HER-2 negative"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e gedatolisib (PF-05212384) • hydroxychloroquine"],"overall_status":"Withdrawn","enrollment":"","initiation":"Initiation: 02/26/2019","start_date":" 02/26/2019","primary_txt":" Primary completion: 08/30/2019","primary_completion_date":" 08/30/2019","study_txt":" Completion: 11/12/2019","study_completion_date":" 11/12/2019","last_update_posted":"2020-04-28"}]