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The MTD of alpelisib in arm B was 350 mg given 4 days on, 3 days off. Among 17 patients assessed, 1 had a partial response, 14 had stable disease, and 2 had disease progression at best response. Five patients had stable disease for 30 weeks. mRNA profiling of pre- and on-treatment tissue demonstrated target engagement by alpelisib via induction of downstream signaling and feedback pathways. Combination treatment with alpelisib, trastuzumab, and LJM716 was limited by gastrointestinal toxicity. Further efforts are w