This is a Phase 1, open-label, dose-escalation ,and multidose study, aiming to investigate the safety, tolerability and pharmacokinetics of Gimatecan in Advanced Ovarian Epithelial Cancer, Fallopian Tube Cancer or Primary Peritoneal Cancer. To explore the dose-limiting toxicity (DLT) and the maximum tolerable dose (MTD) of oral administration of Gimatecan capsules 5 consecutive days, every 28 days.
The clinical trial is used the traditional 3 +3 design and conducted in two dose groups, 0.6mg/m2/d and 0.8mg/m2/d, with an improved dose escalation design. The initial dose is 0.6mg/m2, once a day for 5 consecutive days, every 28 days for a course of treatment. Subjects are assigned to the corresponding dose group according to the order of enrolling. DLT is observed within 28 days of the first dose of Gimatecan. In the absence of DLT as prescribed by the protocol, the next dose group is started until the maximum tolerated dose (MTD) is observed.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
12
0.6mg/m2/d for once a day for 5 consecutive days of Gimatecan
0.8mg/m2/d for once a day for 5 consecutive days of Gimatecan
0.4mg/m2/d for once a day for 5 consecutive days of Gimatecan
Beijing Tumor Hospital
Beijing, Beijing Municipality, China
RECRUITINGDose limiting toxicity(DLT)
Adverse events of level 3 or above related to the study drug occurring within 28 days after the first dose as assessed by CTCAE v5.0.
Time frame: 28 days after first dose
Maximal tolerable dose(MTD)
DLT occurs in less than 1/6 subjects, this lower dose is defined as MTD.
Time frame: 28 days after first dose
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