Phase II Clinical Study of Utidelone Capsule (UTD2) in Patients With Advanced Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
brief summary
This is an open, multicenter, phase II clinical study enrolling patients with platinum-resistant advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer to evaluate the safety and efficacy of Utidelone Capsules. Approximately 72 patients will be included in this study.
detailed description
This study will be two cohorts:
Cohort 1: 30 participants are planned to be enrolled. The administration regimen is Utidelone Capsules at 75 mg/m2/d once a day. Fasting (fasting for 2 hours before administration and 1 hour after administration)is required from the 1st to the 5th day of each 21-day cycle.
Cohort 2: 6 to 12 participants are planned to be enrolled during the safety run-in part, and 30 participants are planned to be enrolled during the expansion part. The administration regimen is the twice daily (BID) administration of Utidelone capsules. The dosage of expansion part will be determined according to the safety run-in part. Fasting (fasting for 2 hours before administration and 1 hour after administration)is required from the 1st to the 5th day of each 21-day cycle.
The safety run-in part use a dose-escalation design. The initial dose was 40 mg/m2 of utidelone capsules BID. The escalation group was set at 50 mg/m2 BID or the de-escalation group at 35 mg/m2 BID. 6 participants will be enrolled in each dose group to evaluate dose-limiting toxicity (DLT).
After the completion of DLT observation during the safety run-in part, one administration regimen will be determined for the dose expansion period.