Therapy Detail

Therapy Name SAR245409
Therapy Description

XL765 (SAR245409) 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).

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Drug Name Trade Name Synonyms Drug Classes Drug Description
SAR245409 XL765|Voxtalisib mTOR Inhibitor 48 PI3K Inhibitor (Pan) 34 XL765 (SAR245409) 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).
Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
PTEN inact mut glioblastoma multiforme sensitive SAR245409 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
Unknown unknown Advanced Solid Tumor not applicable SAR245409 Phase I Actionable In a Phase I trial, SAR245409 (XL765) reduced PI3K and mTORC1/mTORC2 pathway signaling and demonstrated safety and efficacy irrespective of molecular alterations in the PI3K pathway, in patients with advanced solid tumors (PMID: 24583798). 24583798
Unknown unknown Advanced Solid Tumor not applicable SAR245409 Phase I Actionable In a Phase I trial, SAR245409 (XL765) demonstrated safety and efficacy in patients with solid tumors (PMID: 18959794). 18959794
PTEN loss breast adenocarcinoma sensitive SAR245409 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
KRAS mut STK11 inact mut non-small cell lung carcinoma sensitive SAR245409 Preclinical - Cell line xenograft Actionable In a preclinical study, a non-small cell lung carcinoma cell line harboring a KRAS mutation and STK11 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 SAR245409 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
Clinical Trial Phase Therapies Title Recruitment Status
NCT01587040 Phase Ib/II XL147 SAR245409 Open Label Treatment Extension Study With SAR245408 or SAR245409 as a Monotherapy or as a Combination Regimen Completed
NCT01596270 Phase I SAR245409 A Study of the Safety and Pharmacokinetics of SAR245409 Tablets in Patients With Solid Tumors or Lymphoma Completed