2013
DOI: 10.1007/s10637-012-9921-8
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Abstract: Summary Patients with advanced solid malignancies were enrolled to an open-label, single-arm, dose-escalation study, in which CRLX101 was administered intravenously over 60 min among two dosing schedules, initially weekly at 6, 12, and 18 mg/m2 and later bi-weekly at 12, 15, and 18 mg/m2. The maximum tolerated dose (MTD) was determined at 15 mg/m2 bi-weekly, and an expansion phase 2a study was completed. Patient samples were obtained for pharmacokinetic (PK) and pharmacodynamic (PD) assessments. Response was e… Show more

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Cited by 185 publications
(122 citation statements)
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“…2A) revealed excellent reproducibility from patient to patient (7). Additionally, the AUC of the polymer-conjugated and unconjugated CPT increased in a linear, dose-dependent manner (Figs.…”
Section: Discussionmentioning
confidence: 73%
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“…2A) revealed excellent reproducibility from patient to patient (7). Additionally, the AUC of the polymer-conjugated and unconjugated CPT increased in a linear, dose-dependent manner (Figs.…”
Section: Discussionmentioning
confidence: 73%
“…To eliminate the carryover, the administrations were altered to dosing on a biweekly schedule. Patients receiving CRLX101 doses of 15 mg CPT/m 2 on the biweekly schedule showed no polymer-conjugated CPT at 14 d after administration, and, for the unconjugated CPT, they had only 3.1% remaining of the mean maximum concentration (C max ) values (7). This dosing amount and schedule is being used for all phase 2 clinical trials.…”
Section: Discussionmentioning
confidence: 99%
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