This is an open-label nonrandomized multi-center study designed to evaluate the effect of AP23573 in patients with recurrent or persistent endometrial cancer. The primary objective is to assess the efficacy of AP23573 in patients with recurrent or persistent endometrial cancer when administered once daily for 5 consecutive days (QDx5) every two weeks at a dose of 12.5 mg/day.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
45
AP23573 will be administered intravenously (IV) at a fixed dose of 12.5 mg over 30 minutes once daily for 5 days (QDx5) every 2 weeks. A 4-week period comprised of 2 courses of AP23573 is defined as a cycle of treatment.
The primary objective of the study is to assess the efficacy of AP23573 in patients with recurrent or persistent endometrial cancer when administered once daily for 5 consecutive days (QDx5) every two weeks at a dose of 12.5 mg/day.
Time frame: Duration of the study
Assess the safety and tolerability of this study drug regimen in this patient population
Time frame: Duration of the study
Evaluate secondary efficacy endpoints of time to tumor progression, progression-free survival and duration of response
Time frame: Duration of the study
Examine pharmacokinetic characteristics of AP23573
Time frame: Duration of the study
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