Phase I study of nanoliposomal irinotecan (PEP02) in advanced solid tumor patients

  title={Phase I study of nanoliposomal irinotecan (PEP02) in advanced solid tumor patients},
  author={T. C. Chang and H. S. Shiah and C. H. Yang and Kun-Huei Yeh and Ann Lii Cheng and Bei-fen Shen and Y. W. Wang and C. Grace Yeh and N. J. Chiang and J. Y. Chang and L. T. Tai-Hua Chen},
  booktitle={Cancer Chemotherapy and Pharmacology},
To define the dose-limiting toxicity (DLT), maximum tolerated dose (MTD) and pharmacokinetics (PK) of PEP02, a novel liposome-encapsulated irinotecan, in patients with advanced refractory solid tumors. Patients were enrolled in cohorts of one to three to receive escalating dose of PEP02 in a phase I trial. PEP02, from 60 to 180 mg/m2, was given as a 90-min intravenous infusion, every 3 weeks. A total of 11 patients were enrolled into three dose levels: 60 (one patient), 120 (six patients) and… CONTINUE READING
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