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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
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 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
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
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
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

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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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