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Therapy Name | Gedatolisib + Palbociclib |
Synonyms | |
Therapy Description | |
Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
---|---|---|---|---|
Gedatolisib | PKI-587|PF-05212384|PF 05212384 | mTOR Inhibitor 51 PI3K Inhibitor (Pan) 42 | Gedatolisib (PF-05212384) is an ATP-competitive inhibitor that targets phosphatidylinositol 3 kinase (PI3K) and mammalian target of rapamycin (mTOR) in the PI3K/mTOR signaling pathway, and may result in antitumor activity, including inhibition of tumor growth and tumor regression (PMID: 21325073, PMID: 31822716). | |
Palbociclib | Ibrance | PD0332991|PD-0332991 | CDK4/6 Inhibitor 14 | Ibrance (palbociclib) is a selective inhibitor of cyclin-dependent kinase 4 (CDK4) and 6 (CDK6) (PMID: 19874578). Ibrance (palbociclib) is approved in combination with an aromatase inhibitor in postmenopausal patients with ER-positive, ERBB2 (HER2)-negative metastatic breast cancer, and in combination with Faslodex (fulvestrant) in patients with ER-positive, ERBB2 (HER2)-negative metastatic breast cancer (FDA.gov). |
Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
---|---|---|---|---|---|---|---|
BRAF V600E | colorectal carcinoma | sensitive | Gedatolisib + Palbociclib | Preclinical - Cell culture | Actionable | In a preclinical study, the combination of Ibrance (palbociclib) and Gedatolisib (PF-05212384) synergistically inhibited growth of a colorectal carcinoma cell line harboring BRAF V600E in culture (PMID: 37326340). | 37326340 |
PIK3CA E545G | colorectal adenocarcinoma | sensitive | Gedatolisib + Palbociclib | Preclinical - Cell culture | Actionable | In a preclinical study, the combination of Ibrance (palbociclib) and Gedatolisib (PF-05212384) synergistically inhibited growth of a colorectal adenocarcinoma cell line harboring PIK3CA E545G in culture (PMID: 37326340). | 37326340 |
Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
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NCT03065062 | Phase I | Gedatolisib + Palbociclib | 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 | Recruiting | USA | 0 |
NCT02684032 | Phase I | Letrozole Fulvestrant Gedatolisib + Palbociclib | 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 | Completed | USA | 0 |