Etirinotecan pegol administration resulted in sustained and controlled systemic exposure to SN-38, which had a mean half-life of approximately 50 days. Cholinergic diarrhea commonly seen with irinotecan treatment did not occur in patients treated with etirinotecan pegol. Late onset diarrhea was observed in some patients, the frequency of which generally correlated with dose density. Most adverse events related to study drug were gastrointestinal disorders and were more frequent at higher doses of etirinotecan pegol. The MTD was 115 mg/m 2 for the w × 3q4w schedule and 145 mg/m 2 for both the q14d and q21d schedules. Results: Seventy-six patients were entered onto 3 dosing schedules (58–245 mg/m 2). Patients received 1 infusion of etirinotecan pegol weekly 3 times every 4 weeks (w × 3q4w), or every 14 days (q14d), or every 21 days (q21d), with MTD as the primary end point using a standard 3 + 3 design. Purpose: This study was designed to establish the maximum tolerated dose (MTD) and to evaluate tolerability, pharmacokinetics, and antitumor activity of etirinotecan pegol.Įxperimental Design: Patients with refractory solid malignancies were enrolled and assigned to escalating-dose cohorts.
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