ZIO-201在晚期肉瘤中的研究

Participants received palifosfamide-lysine 590 mg/m² by intravenous infusion over approximately 15 minutes on Days 1, 2, and 3 of each 21-day cycle. Four participants were treated at this dose level. Dose escalation was discontinued after 2 of 4 participants experienced dose-limiting toxicities during Cycle 1.

Palifosfamide-lysine (ZIO-201) was administered by intravenous infusion on Days 1, 2, and 3 of each 21-day cycle. Dose and formulation are specified in the corresponding Arm descriptions.

• palifosfamide

Participants received palifosfamide-lysine 413 mg/m² by intravenous infusion over approximately 15 minutes on Days 1, 2, and 3 of each 21-day cycle. Forty-nine participants were treated at this dose level. The last 6 participants enrolled also participated in a pharmacokinetic substudy in which they received a single dose of palifosfamide-tris 178 mg/m² on Day -14 before beginning palifosfamide-lysine treatment.

Palifosfamide-lysine (ZIO-201) was administered by intravenous infusion on Days 1, 2, and 3 of each 21-day cycle. Dose and formulation are specified in the corresponding Arm descriptions.

• palifosfamide

DLTs were assessed during the first 21-day cycle to determine the maximum tolerated dose (MTD). A DLT was defined as any of the following:

a non-hematologic Grade 3 toxicity that did not resolve to Grade 2 or lower within 72 hours, excluding alopecia any non-hematologic Grade 4 toxicity, excluding alopecia Grade 4 granulocyte and/or platelet toxicity lasting 7 days or longer Grade 3 or higher neutropenia with an unexplained temperature of 38.5°C or higher on 2 or more occasions within 24 hours The MTD was the dose level below the dose at which at least 33% of participants had a DLT.

Cmax of palifosfamide, measured from blood samples collected during Cycle 1 dosing.

AUC0-inf of palifosfamide, measured from blood samples collected during Cycle 1 dosing.