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Therapy Name | Gedatolisib |
Synonyms | |
Therapy Description |
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). |
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). |
Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
---|---|---|---|---|---|---|---|
PIK3CA H1047R | head and neck squamous cell carcinoma | sensitive | Gedatolisib | Preclinical - Cell culture | Actionable | In a preclinical study, head and neck squamous cell carcinoma cell lines harboring PIK3CA H1047R demonstrated sensitivity to treatment with Gedatolisib (PF-05212384) in culture (PMID: 25977343). | 25977343 |
PIK3CA E545K | breast cancer | sensitive | Gedatolisib | Preclinical | Actionable | In a preclinical study, Gedatolisib (PKI-587) inhibited growth of human breast cancer cells harboring PIK3CA E545K in culture (PMID: 21325073, PMID: 17314276). | 17314276 21325073 |
PTEN loss VHL loss | renal carcinoma | decreased response | Gedatolisib | Preclinical | Actionable | In a preclinical study, human renal carcinoma cells with PTEN loss and VHL loss had a decreased response to Gedatolisib (PKI-587) in culture (PMID: 21325073). | 21325073 |
PTEN loss | renal carcinoma | decreased response | Gedatolisib | Preclinical | Actionable | In a preclinical study, human renal carcinoma cells with PTEN loss had a decreased response to Gedatolisib (PKI-587) in culture (PMID: 21325073). | 21325073 |
PIK3CA H1047R | breast cancer | sensitive | Gedatolisib | Preclinical | Actionable | In a preclinical study, Gedatolisib (PKI-587) inhibited growth of human breast cancer cells harboring PIK3CA H1047R in culture (PMID: 21325073, PMID: 17314276). | 17314276 21325073 |
PIK3CA act mut | head and neck squamous cell carcinoma | sensitive | Gedatolisib | Preclinical | Actionable | In a preclinical study, PF-05212384 decreased viability of head and neck squamous carcinoma cells harboring a PIK3CA activating mutation in cell culture (PMID: 24823695). | 24823695 |
BRAF V600E | colon cancer | sensitive | Gedatolisib | Preclinical | Actionable | In a preclinical study, Gedatolisib (PKI-587) inhibited Braf V600E in vitro and inhibited growth of human colon cancer cells harboring BRAF V600E in culture (PMID: 21325073, PMID: 24042735). | 24042735 21325073 |
PIK3CA over exp | head and neck squamous cell carcinoma | sensitive | Gedatolisib | Preclinical - Cell culture | Actionable | In a preclinical study, some head and neck squamous cell carcinoma cell lines over expressing PIK3CA demonstrated sensitivity to treatment with Gedatolisib (PF-05212384) (PMID: 25977343). | 25977343 |
NRAS Q61K | lung non-small cell carcinoma | decreased response | Gedatolisib | Preclinical | Actionable | In a preclinical study, human non-small cell lung cancer cells harboring NRAS Q61K had a decreased response to Gedatolisib (PKI-587) in culture (PMID: 21325073, PMID: 12068308). | 21325073 12068308 |
PTEN del | prostate cancer | sensitive | Gedatolisib | Preclinical | Actionable | In a preclinical study, Gedatolisib (PKI-587) inhibited growth of human prostate cancer cells harboring PTEN deletion in culture (PMID: 21325073, PMID: 14737113). | 14737113 21325073 |
PTEN A72fs | breast cancer | sensitive | Gedatolisib | Preclinical | Actionable | In a preclinical study, Gedatolisib (PKI-587) inhibited growth of human breast cancer cells harboring PTEN A72fs*5 in culture (PMID: 21325073, PMID: 17314276). | 17314276 21325073 |
TP53 R158G | lung non-small cell carcinoma | sensitive | Gedatolisib | Preclinical | Actionable | In a preclinical study, Gedatolisib (PKI-587) inhibited growth of human non-small cell lung carcinoma cells harboring TP53 R158G in culture (PMID: 21325073, PMID: 23980093). | 21325073 23980093 |
PTEN loss | brain glioma | sensitive | Gedatolisib | Preclinical | Actionable | In a preclinical study, Gedatolisib (PKI-587) inhibited growth of human glioma cells with PTEN loss in culture (PMID: 21325073). | 21325073 |
Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
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NCT02626507 | Phase I | Palbociclib Gedatolisib Goserelin Fulvestrant | Phase I Study of Combination of Gedatolisib With Palbociclib and Faslodex in Patients With ER+/HER2- Breast Cancer | Unknown status | USA | 0 |
NCT01937715 | Phase II | Bevacizumab Gedatolisib Fluorouracil + Irinotecan + Leucovorin | A Study Of PF-05212384 Plus FOLFIRI Versus Bevacizumab Plus FOLFIRI In Metastatic Colorectal Cancer | Terminated | USA | ESP | CAN | 0 |
NCT01347866 | Phase I | Gedatolisib PD-0325901 Irinotecan | Clinical Study Of PI3K/mTOR Inhibitors In Combination With An Oral MEK Inhibitor Or Irinotecan In Patients With Advanced Cancer | Terminated | USA | ITA | ESP | CAN | 0 |
NCT05134922 | Expanded access | Gedatolisib | Expanded Access Protocol for Subjects Previously Treated With Gedatolisib in B2151009 | Available | USA | 0 |