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- W4361961149 abstract "<div>Abstract<p><b>Purpose:</b> CPX-1 is a novel, liposome-encapsulated formulation of irinotecan and floxuridine designed to prolong <i>in vitro</i> optimized synergistic molar ratios of both drugs postinfusion. This open-label, single-arm, dose-escalating phase I study was designed to determine the maximum tolerated dose and pharmacokinetics of CPX-1 in patients with advanced solid tumors.</p><p><b>Experimental Design:</b> Patients received CPX-1 at 30, 60, 100, 150, 210, or 270 units/m<sup>2</sup> (1 unit = 1 mg irinotecan + 0.36 mg floxuridine) infused over 90 minutes every 14 days in 28-day cycles. Pharmacokinetic samples were collected on days 1 and 15 of cycle 1.</p><p><b>Results:</b> Thirty-three patients were enrolled, treated, and evaluated for safety; 30 patients were evaluated for response. A 1:1 plasma irinotecan to floxuridine molar ratio was maintained for 8 to 12 hours. Grade 3/4 toxicities included diarrhea (24.2%), neutropenia (12.1%), and hypokalemia (12.1%); 1 patient (270 units/m<sup>2</sup>) died of persistent diarrhea, which led to dehydration and renal failure (grade 5). Partial response occurred in 3 (12%) of the 25 subjects evaluated through Response Evaluation Criteria in Solid Tumors. Progression-free survival lasting >6 months occurred in 9 patients, 6 with colorectal cancer. Among 15 colorectal cancer patients (10 with prior irinotecan), the calculated median progression-free survival was 5.4 months; 11 patients (72.7%) achieved disease control and 2 patients (13%) had partial response.</p><p><b>Conclusions:</b> Outpatient CPX-1 was well tolerated and antitumor activity was shown in patients with advanced solid tumors. The recommended dose for future studies is 210 units/m<sup>2</sup>. This is the first clinical evaluation of fixed drug ratio dosing designed to maintain synergistic molar ratios for enhanced therapeutic benefit.</p></div>" @default.
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- W4361961149 date "2023-03-31" @default.
- W4361961149 modified "2023-10-18" @default.
- W4361961149 title "Data from Safety, Pharmacokinetics, and Efficacy of CPX-1 Liposome Injection in Patients with Advanced Solid Tumors" @default.
- W4361961149 doi "https://doi.org/10.1158/1078-0432.c.6517425" @default.
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