3 recruiting, 2 active not recruiting, 1 available, 1 completed. 6 Phase 2, 4 Phase 1, 2 Phase 3.
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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 |
| Fulvestrant + Neratinib In Breast Cancer NERATINIB, FULVESTRANT - Stage IV (Metastatic) Breast Cancer, Metastatic Breast Cancer | Phase 2 | Withdrawn | Massachusetts General Hospital | 2023-07-01 | 2023-08-01 | |
| 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 |
| Neratinib and Capmatinib Combination (Phase Ib/II) in Metastatic Breast Cancer and Inflammatory Breast Cancer Patients With Abnormal HER-family and c-Met Pathway Activity as Measured by the CELsignia Signaling Analysis Test Neratinib, Capmatinib - Metastatic Breast Cancer, Breast Cancer | Phase 1 / Phase 2 | Terminated | M.D. Anderson Cancer Center | 10 | 2022-08-18 | 2025-06-11 |
| Evaluating the Efficacy of Neratinib on Live Cell HER2 Signaling Transduction Analysis Positive Triple Negative Breast Neratinib - Triple Negative Breast Cancer, Early-stage Breast Cancer | Phase 2 | Unknown | West Cancer Center | 27 | 2019-06-21 | 2023-12-18 |
| 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 |
| 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 |
| 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 |
| Expanded Access Protocol for Subjects Previously Treated With Gedatolisib in B2151009 Gedatolisib - Breast Neoplasm Malignant Female | Available | Celcuity Inc | 2025-03-21 |
Breast Neoplasms (6) · Neoplasm Metastasis (3) · Triple Negative Breast Neoplasms (2) · Endometrial Neoplasms (1) · Genital Diseases, Male (1) · Hereditary Sensory and Autonomic Neuropathies (1) · Male Urogenital Diseases (1) · Prostatic Diseases (1) · Prostatic Neoplasms (1) · Prostatic Neoplasms, Castration-Resistant (1)
gedatolisib (7) · Fulvestrant (4) · Letrozole (3) · neratinib (3) · palbociclib (3) · Alpelisib (1) · LY3023414 (1) · Metformin (1) · abemaciclib (1) · capmatinib (1) · darolutamide (1) · ribociclib (1) · talazoparib (1)
United States (10) · France (3) · Spain (3) · United Kingdom (3) · Argentina (2) · Australia (2) · Belgium (2) · Bulgaria (2) · Czechia (2) · Germany (2) · Greece (2) · Hungary (2) · Italy (2) · Mexico (2) · Poland (2)
Aditya Bardia, MD,MPH (1) · Gregory A Vidal, MD.,PhD (1) · Igor Gorbatchevsky, MD (1) · Kari Wisinski, MD (1) · Nadene Zack (1) · Nadene Zack, MS (1) · Panagiotis Konstantininopoulos, MD (1) · Rachel Layman (1)
PMID 27713176, PMID 28302091, PMID 36174113, PMID 38547892, PMID 40471518, PMID 41802242