Grade 3 toxicities included diarrhea, fatigue, nausea and vomiting, no grade 4 events were reported. Most common non-hematological grade 1 and 2 adverse events were nausea, fatigue, diarrhea, vomiting and cholinergic syndrome. Totally six patients experienced grade 1/2 anemia, three patients had grade 1/2 leucopenia and 1 patient had grade 1 thrombocytopenia. No grade 3/4 hematologic toxicities were reported. Among these five patients had previously received irinotecan. Nine patients (36%) had stable disease (SD), lasting median 19 weeks (range 7–45 weeks). Median number of prior therapies was 3 (range 1–6). Median age was 67 years, 52% were performance status (PS) 0 while 48% were PS 1. ResultsĢ5 patients were included across four cohorts 3 patients were included in cohort 1 (20 mg/m 2), 7 patients were included in cohort 2 (30 mg/m 2), 3 patients were included in cohort 3 (25 mg/m 2) and 12 patients were included in cohort 4 (21 mg/m 2).

Each treatment cycle was once-daily irinotecan for 14 days followed by 1 week rest.

MethodsĪ phase I, dose escalating study to assess safety, tolerability, pharmacokinetics and efficacy of an oral irinotecan formulation and to establish the maximum tolerated dose (MTD). In this study, we present a new oral irinotecan formulation designed as an enteric coated immediate release tablet which in pre-clinical studies has shown good exposure with low variability. Apart from patient convenience and favorable pharmacoeconomics, they offer the possibility of frequent drug administration at home. Oral drug formulations have several advantages compared to intravenous formulation.

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