Alpelisib in combination with everolimus ± exemestane in solid tumours: Phase Ib randomised, open-label, multicentre study

• Published in: European journal of cancer (1990) Vol. 151; pp. 49 - 62
• Main Authors: Curigliano, Giuseppe, Martin, Miguel, Jhaveri, Komal, Beck, J.T., Tortora, Giampaolo, Fazio, Nicola, Maur, Michela, Hubner, Richard A., Lahner, Harald, Donnet, Valerie, Ajipa, Olga, Li, Zheng, Blumenstein, Lars, Andre, Fabrice
• Format: Journal Article
• Language: English
• Published: England Elsevier Ltd 01.07.2021; Elsevier Science Ltd
• Subjects: 1-Phosphatidylinositol 3-kinase; Advanced breast cancer; Adverse events; Alpelisib; Appetite loss; Asthenia; Breast cancer; Confidence intervals; Diarrhea; Drug dosages; Drug interaction; Drug interactions; Epidermal growth factor; ErbB-2 protein; Everolimus; Exemestane; Growth factors; Hormone receptor–positive; Human epidermal growth factor receptor 2–negative; Hyperglycemia; Hypocalcemia; Inhibitor drugs; Kidney cancer; Kinases; Maximum tolerated dose; Nausea; Neuroendocrine tumors; Pancreas; Pancreatic cancer; Patients; Pharmacokinetics; Pharmacology; PI3K; Post-menopause; Rapamycin; Receptors; Recommended dose for expansion; Renal cell carcinoma; Safety; Solid tumors; Stomatitis; Survival; Targeted cancer therapy; TOR protein; Toxicity; Tumors; PI3K; Advanced breast cancer; Hormone receptor–positive; Alpelisib; Maximum tolerated dose; Human epidermal growth factor receptor 2–negative; Exemestane; Pharmacokinetics; Recommended dose for expansion; Everolimus

Combined mTORC1 inhibition with everolimus (EVE) and phosphatidylinositol 3-kinase catalytic subunit p110α blockade with alpelisib (ALP) has demonstrated synergistic efficacy in preclinical models and supports testing the combination of ALP and EVE in the clinical setting. The primary objective was...