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10.1016/j.ejca.2015.06.115

http://scihub22266oqcxt.onion/10.1016/j.ejca.2015.06.115
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C5693226!5693226!26199039
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suck abstract from ncbi


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pmid26199039      Eur+J+Cancer 2015 ; 51 (14): 1865-73
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  • Results of a phase 1 trial combining ridaforolimus and MK-0752 in patients with advanced solid tumors #MMPMID26199039
  • Piha-Paul S; Munster P; Hollebecque A; Argilés G; Dajani O; Cheng J; Wang R; Swift A; Tosolini A; Gupta. S
  • Eur J Cancer 2015[Sep]; 51 (14): 1865-73 PMID26199039show ga
  • Background: The phosphatidylinositol 3-kinase/protein kinase-B/mammalian target of rapamycin (PI3K-AKT-mTOR) signaling pathway is aberrantly activated in several cancers. Notch signaling maintains cell proliferation, growth, and metabolism in part by driving the PI3K pathway. Combining the mTOR inhibitor ridaforolimus with the Notch inhibitor MK-0752 may increase blockade of the PI3K pathway. Methods: This phase I dose-escalation study (NCT01295632) aimed to define the dose-limiting toxicities (DLTs) and maximum tolerated dose (MTD) of combination oral ridaforolimus (rising doses starting at 20 mg, 5 days/week) and oral MK-0752 (1800 mg once weekly) in patients with solid tumors. No intrapatient dose escalation was permitted. Results: 28 patients were treated on study. Ridaforolimus doses were escalated from 20 to 30 mg/day. Among 14 evaluable patients receiving ridaforolimus 20 mg, one DLT (grade 2 stomatitis, second episode) was reported. Among 8 evaluable patients receiving ridaforolimus 30 mg, three DLTs were reported (1 each grade 3 stomatitis, grade 3 diarrhea, and grade 3 asthenia). The MTD was 20 mg daily ridaforolimus 5 days/week + 1800 mg weekly MK-0752. The most common drug-related adverse events included stomatitis, diarrhea, decreased appetite, hyperglycemia, thrombocytopenia, asthenia, and rash. Two of 15 (13%) patients with head and neck squamous cell carcinoma (HNSCC) had responses: one with complete response (CR) and one with partial response (PR). In addition, one patient experienced stable disease ?6 months. Conclusions: Combined ridaforolimus and MK-0752 showed activity in HNSCC. However, a high number of adverse events were reported at the MTD, which would require careful management during future clinical development.
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