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Therapy Name	Voxtalisib
Synonyms
Therapy Description	Voxtalisib (XL765) inhibits both PI3K and mTOR kinases and results in inhibition of PI3K pathway signaling, thereby possibly leading to inhibition of cell proliferation, reduced tumor vascularization, and inhibition of tumor growth (PMID: 24634413, PMID: 31870556).

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Drug Name	Trade Name	Synonyms	Drug Classes	Drug Description
Voxtalisib		XL765\|XL-765\|SAR245409\|SAR-245409	mTOR Inhibitor 51 PI3K Inhibitor (Pan) 42	Voxtalisib (XL765) inhibits both PI3K and mTOR kinases and results in inhibition of PI3K pathway signaling, thereby possibly leading to inhibition of cell proliferation, reduced tumor vascularization, and inhibition of tumor growth (PMID: 24634413, PMID: 31870556).

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Molecular Profile	Indication/Tumor Type	Response Type	Therapy Name	Approval Status	Evidence Type	Efficacy Evidence	References
PIK3CA amp	ovarian cancer	sensitive	Voxtalisib	Preclinical - Cell line xenograft	Actionable	In a preclinical study, an ovarian cancer cell line harboring PIK3CA E545K was sensitive to XL765 (SAR245409), demonstrating inhibition of cell proliferation in culture, and inhibition of tumor growth in cell line xenograft models (PMID: 24634413).	24634413
PIK3CA E545K	breast cancer	sensitive	Voxtalisib	Preclinical - Cell line xenograft	Actionable	In a preclinical study, a breast cancer cell line harboring PIK3CA E545K was sensitive to XL765 (SAR245409), demonstrating inhibition of cell proliferation and colony formation in culture, and inhibition of tumor growth in cell line xenograft models (PMID: 24634413).	24634413
PTEN inact mut	glioblastoma	sensitive	Voxtalisib	Preclinical - Cell line xenograft	Actionable	In a preclinical study, a glioblastoma cell line harboring a PTEN inactivating mutation was sensitive to XL765 (SAR245409), demonstrating inhibition of cell proliferation in culture, and inhibition of tumor growth in cell line xenograft models (PMID: 24634413).	24634413
PTEN loss	prostate cancer	sensitive	Voxtalisib	Preclinical - Cell line xenograft	Actionable	In a preclinical study, a prostate cancer cell line with PTEN loss was sensitive to XL765 (SAR245409) treatment, demonstrating inhibition of the PI3K pathway and decreased colony formation in culture, and inhibition of tumor growth and reduced tumor vascularization in cell line xenograft models (PMID: 24634413).	24634413
PTEN loss	breast adenocarcinoma	sensitive	Voxtalisib	Preclinical - Cell culture	Actionable	In a preclinical study, a breast adenocarcinoma cell line harboring PTEN loss was sensitive to XL765 (SAR245409), demonstrating inhibition of cell proliferation in culture (PMID: 24634413).	24634413

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Clinical Trial	Phase	Therapies	Title	Recruitment Status	Covered Countries	Other Countries
NCT01587040	Phase Ib/II	XL147 Voxtalisib	Open Label Treatment Extension Study With SAR245408 or SAR245409 as a Monotherapy or as a Combination Regimen	Completed	USA \| FRA \| ESP \| BEL	0
NCT01596270	Phase I	Voxtalisib	A Study of the Safety and Pharmacokinetics of SAR245409 Tablets in Patients With Solid Tumors or Lymphoma	Completed	USA	0

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