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Therapy Name Serabelisib
Synonyms
Therapy Description

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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Drug Name Trade Name Synonyms Drug Classes Drug Description
Serabelisib INK1117|TAK-117|MLN-1117|MLN1117 PIK3CA inhibitor 24 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).

Filtering

  • Case insensitive filtering will display rows if any text in any cell matches the filter term
  • Use simple literal full or partial string matches
  • Separate multiple filter terms with a space. Any order may be used (i. e. a b c and c b a are equivalent )
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  • Use quotes to match on a longer phrase with spaces (i.e. "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 Serabelisib 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 breast cancer predicted - sensitive Serabelisib 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
PIK3CA mutant Advanced Solid Tumor sensitive Serabelisib 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 Serabelisib 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...

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT02551055 Phase I Docetaxel Paclitaxel Alisertib Mivavotinib Serabelisib MLN1117 in Combination With Docetaxel, Paclitaxel, and Other Investigational Anticancer Agents to Treat Participants With Gastric and Gastroesophageal Adenocarcinoma Terminated USA | ESP 0
NCT05300048 Phase I Serabelisib Nab-paclitaxel + Serabelisib Combination of Serabelisib and Insulin Suppressing Diet With or Without Nab-paclitaxel in Subjects With Advanced Solid Tumors With PIK3CA Mutations Active, not recruiting USA 0
NCT01449370 Phase I Serabelisib Dose Escalation Study of MLN1117 in Subjects With Advanced Cancer Completed USA | GBR | ESP 0


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