6 completed, 6 terminated, 3 recruiting, 2 active not recruiting. 14 Phase 1, 10 Phase 2, 2 Phase 3.
Follow gedatolisib: new trials by email Literature Review of gedatolisib trials Research Report on gedatolisib
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Phase 3 Study of Gedatolisib as First-Line Treatment for Patients With HR-Positive, HER2-Negative Advanced Breast Cancer (VIKTORIA-2) Arm A: Gedatolisib + Palbociclib + Fulvestrant, Arm B: Ribociclib + Fulvestrant, Arm C: Gedatolisib + Palbociclib + Letrozole - Breast Cancer | Phase 3 | Recruiting | Celcuity Inc | 1180 | 2025-07-24 | 2026-10-09 |
| Gedatolisib in Combination With Darolutamide in Metastatic Castration-Resistant Prostate Cancer Gedatolisib, Darolutamide - mCRPC (Metastatic Castration-resistant Prostate Cancer), Genital Diseases, Male | Phase 1 / Phase 2 | Recruiting | Celcuity Inc | 54 | 2024-01-01 | 2026-04-13 |
| 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) Gedatolisib, Palbociclib, Fulvestrant - Breast Cancer | Phase 3 | Active not recruiting | Celcuity Inc | 701 | 2022-12-08 | 2026-02-10 |
| Phase II Study of Herzuma® Plus Gedatolisib in Patients With HER-2 Positive Metastatic Breast Cancer Trastuzumab biosimilars(Herzuma), Gedatolisib - HER2-positive Breast Cancer, Metastatic Breast Cancer | Phase 2 | Unknown | Korean Cancer Study Group | 15 | 2019-12-03 | 2021-02-18 |
| Gedatolisib Plus Talazoparib in Advanced Triple Negative or BRCA1/2 Positive, HER2 Negative Breast Cancers Gedatolisib, Talazoparib - TNBC - Triple-Negative Breast Cancer | Phase 1 / Phase 2 | Active not recruiting | Kari Wisinski | 37 | 2019-04-17 | 2024-06-07 |
| Gedatolisib, Hydroxychloroquine or the Combination for Prevention of Recurrent Breast Cancer ("GLACIER") Hydroxychloroquine (HCQ), Gedatolisib - Breast Cancer | Phase 1 / Phase 2 | Withdrawn | Abramson Cancer Center at Penn Medicine | 2019-02-26 | 2020-04-28 | |
| RESOLVE: Abemaciclib + Letrozole +/- Metformin or Gedatolisib in Endometrial Cancer Letrozole, Abemaciclib, LY3023414 - Endometrial Cancer | Phase 2 | Recruiting | Dana-Farber Cancer Institute | 110 | 2018-12-24 | 2026-06-22 |
| An Initial Safety Study of Gedatolisib Plus PTK7-ADC for Metastatic Triple-negative Breast Cancer Gedatolisib, PTK7-ADC - Triple Negative Breast Cancer, Metastatic Breast Cancer | Phase 1 | Completed | Kathy Miller | 18 | 2018-01-19 | 2021-01-07 |
| Study of Paclitaxel, Carboplatin, and PF-05212384 in Advanced or Metastatic NSCLC (UF-STO-LUNG-002) Gedatolisib, Paclitaxel, Carboplatin - Non-Small Cell Lung Cancer | Phase 1 / Phase 2 | Terminated | University of Florida | 3 | 2017-09-25 | 2019-10-04 |
| 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 Palbociclib, Gedatolisib - Lung Cancer Squamous Cell, Solid Tumors | Phase 1 | Suspended | Dana-Farber Cancer Institute | 75 | 2017-02-28 | 2026-02-13 |
| 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 Gedatolisib, Palbociclib, Letrozole - Breast Cancer | Phase 1 | Completed | Celcuity Inc | 141 | 2016-06-14 | 2022-07-27 |
| Phase I Study of Combination of Gedatolisib With Palbociclib and Faslodex in Patients With ER+/HER2- Breast Cancer Gedatolisib, Faslodex, Palbociclib - Breast Cancer | Phase 1 | Unknown | Hoffman Oncology | 18 | 2016-01-01 | 2022-02-09 |
| PF-05212384 (PKI-587) for t-AML/MDS or de Novo Relapsed or Refractory Acute Myeloid Leukemia (AML) (LAM-PIK) PF-05212384 - Therapy-related Acute Myeloid Leukemia and Myelodysplastic Syndrome, Acute Myeloid Leukemia, in Relapse | Phase 2 | Terminated | Institut Curie | 10 | 2015-08-31 | 2025-09-08 |
| Investigation Of The Metabolism, And Excretion Of [14c]-PF-05212384 In Healthy Male Volunteers PF-05212384 - Healthy | Phase 1 | Completed | Pfizer | 6 | 2014-07-01 | 2014-09-04 |
| Dose Finding Study Of PF-05212384 With Paclitaxel And Carboplatin In Patients With Advanced Solid Tumor PF-05212384, Paclitaxel, Carboplatin - Breast Cancer, NSCLC | Phase 1 | Completed | Cristiana Sessa | 17 | 2014-04-01 | 2019-05-21 |
| A Study Of PF-05212384 Plus FOLFIRI Versus Bevacizumab Plus FOLFIRI In Metastatic Colorectal Cancer PF-05212384, FOLFIRI regimen, Bevacizumab - Metastatic Colorectal Carcinoma | Phase 1 / Phase 2 | Terminated | Pfizer | 18 | 2014-02-01 | 2016-08-18 |
| A Study Of PF-05212384 Plus Irinotecan Vs Cetuximab Plus Irinotecan In Patients With KRAS And NRAS Wild Type Metastatic Colorectal Cancer PF-05212384, irinotecan, Cetuximab - Metastatic Colorectal Cancer | Phase 2 | Terminated | Pfizer | 19 | 2013-11-15 | 2019-01-08 |
| 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) PF-05212384 (gedatolisib), Docetaxel, Cisplatin - Neoplasm | Phase 1 | Completed | Pfizer | 110 | 2013-09-10 | 2022-09-13 |
| A Study Of Two Dual PI3K/mTOR Inhibitors, PF-04691502 And PF-05212384 In Patients With Recurrent Endometrial Cancer PF-05212384 - Endometrial Neoplasms | Phase 2 | Terminated | Pfizer | 67 | 2012-01-19 | 2019-01-08 |
| Clinical Study Of PI3K/mTOR Inhibitors In Combination With An Oral MEK Inhibitor Or Irinotecan In Patients With Advanced Cancer PF-05212384, PD-0325901, irinotecan - Advanced Cancer | Phase 1 | Terminated | Pfizer | 105 | 2011-10-01 | 2018-10-29 |
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Breast Neoplasms (8) · Endometrial Neoplasms (4) · Neoplasm Metastasis (4) · Neoplasms (4) · Triple Negative Breast Neoplasms (3) · Colorectal Neoplasms (2) · Carcinoma (1) · Carcinoma, Non-Small-Cell Lung (1) · Colonic Neoplasms (1) · Genital Diseases, Male (1) · Head and Neck Neoplasms (1) · Hereditary Sensory and Autonomic Neuropathies (1) · Leukemia, Myeloid, Acute (1) · Male Urogenital Diseases (1) · Myelodysplastic Syndromes (1)
Pfizer (7) · Celcuity Inc (5) · Dana-Farber Cancer Institute (2) · Abramson Cancer Center at Penn Medicine (1) · Cristiana Sessa (1) · Hoffman Oncology (1) · Institut Curie (1) · Kari Wisinski (1) · Kathy Miller (1) · Korean Cancer Study Group (1) · University of Florida (1)
United States (18) · Spain (9) · United Kingdom (7) · Canada (5) · France (4) · Italy (4) · South Korea (4) · Australia (3) · Poland (3) · Argentina (2) · Belgium (2) · Bulgaria (2) · Czechia (2) · Germany (2) · Greece (2)
Anastasios Stathis, Prof. (1) · Angela DeMichele, MD (1) · Anthony Hoffman, MD (1) · Dennie Jones, MD (1) · Geoffrey Shapiro, MD (1) · Igor Gorbatchevsky, MD (1) · Jacques Vargaftig, MD (1) · Kari Wisinski, MD (1) · Kathy Miller, MD (1) · Kyong Hwa Park, MD, PhD (1) · Milan Radovich, PhD (1) · Nadene Zack (1) · Nadene Zack, MS (1) · Panagiotis Konstantininopoulos, MD (1)
PMID 25652454, PMID 27103175, PMID 30256541, PMID 36174113, PMID 36335217, PMID 38547892, PMID 40471518, PMID 41802242
2009 (1)