Phase I study of the PI3K/mTOR inhibitor PF-05212384 in combination with other antitumor agents.

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Abstract
2590 Background: Inhibition of phosphatidylinositol-3-kinase (PI3K)-mediated signaling may overcome resistance to different classes of chemotherapies as well as epidermal growth factor receptor (EGFR) inhibitors. PF-05212384 (PF384) is an intravenous (IV) inhibitor of PI3K/mammalian target of rapamycin (mTOR) in development for metastatic colorectal cancer and other solid tumors in combination with other agents. Methods: An ongoing phase I dose escalation study is enrolling cohorts of 3–6 patients (pts) to determine maximum tolerated dose (MTD) and safety of PF384 plus docetaxel (arm A), cisplatin (arm B), or the EGFR tyrosine kinase inhibitor dacomitinib (arm C). Eligible pts have castrate resistant prostate cancer, advanced breast cancer, or non-small cell lung cancer (NSCLC; arm A); urothelial transitional cell cancer, triple negative breast cancer, or NSCLC (arm B); or refractory Her2+ breast cancer, Her2+ esophagogastric cancer, head and neck squamous cell cancer, or EGFR-mutated NSCLC (arm C). Dose ...