Therapy Detail

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Therapy Name MLN1117
Synonyms
Therapy Description

MLN1117 (INK1117) selectively inhibits PI3K alpha kinase, including mutations of PIK3CA, and therefore, targets the PI3K/Akt/mTOR pathway with potentially less toxicity than pan-PI3K inhibitors (NCI Drug Dictionary).

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Drug Name Trade Name Synonyms Drug Classes Drug Description
MLN1117 INK1117|TAK-117|Serabelisib|MLN-1117 PIK3CA inhibitor 16 Serabelisib (MLN1117) selectively inhibits PI3K alpha kinase, including mutations of PIK3CA, and therefore, targets the PI3K/Akt/mTOR pathway with potentially less toxicity than pan-PI3K inhibitors (PMID: 28490463, PMID: 30168905).

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  • Use quotes to match a longer phrase which contains spaces "mtor c1483f"

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
PIK3CA mutant stomach cancer predicted - sensitive MLN1117 Case Reports/Case Series Actionable In a Phase I trial, MLN1117 (INK1117) treatment resulted in a partial response in one patient with gastric cancer harboring a PIK3CA mutation (PMID: 28490463; NCT01449370). 28490463
PIK3CA mutant Advanced Solid Tumor sensitive MLN1117 Preclinical Actionable In a preclinical study, MLN1117 inhibited proliferation of tumor cells harboring oncogenic PIK3CA mutations in culture and inhibited tumor growth in PIK3CA mutant xenograft models (Cancer Ther 2011;10(11 Suppl):Abstract nr A171). detail...
PIK3CA mutant Advanced Solid Tumor sensitive MLN1117 Phase I Actionable In a Phase I trial, MLN1117 demonstrated safety and preliminary efficacy in a variety of patients with advanced solid tumors carrying PIK3CA mutations (Journal of Clinical Oncology, 2015 ASCO Annual Meeting Vol 33, No 15_suppl., 2015: 2501). detail...
PIK3CA mutant breast cancer predicted - sensitive MLN1117 Case Reports/Case Series Actionable In a Phase I trial, MLN1117 (INK1117) treatment resulted in partial response in 3 patients with breast cancer harboring PI3CA mutations (PMID: 28490463; NCT01449370). 28490463
Unknown unknown breast cancer not applicable MLN1117 Phase I Actionable In a Phase I trial, treatment with MLN1117 resulted in antitumor activity, demonstrating partial responses in patients with advanced solid tumors including breast and gastric cancer (J Clin Oncol, May 2015 vol. 33 no. 15_suppl 2501). detail...

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Clinical Trial Phase Therapies Title Recruitment Status
NCT01449370 Phase I MLN1117 Dose Escalation Study of MLN1117 in Subjects With Advanced Cancer Completed
NCT02551055 Phase I Docetaxel Paclitaxel Alisertib Mivavotinib MLN1117 MLN1117 in Combination With Docetaxel, Paclitaxel, and Other Investigational Anticancer Agents to Treat Participants With Gastric and Gastroesophageal Adenocarcinoma Terminated


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