Gynecol Oncol: Phase I study of newly diagnosed ovarian cancer, primary peritoneal cancer and intra-abdominal platinum chemotherapy combined with Veliparib and Beivaczumab
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Last Update: 2020-07-14
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Source: Internet
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Author: User
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Improvements in epithelialovarian cancer, peritoneal cancer or eOC disease-free survival can only be achieved through improved primary treatmentAdding polyADP-ribonucleic inhibitors (PARPi) to a front-line environment may represent a strategyThe purpose of this study is to determine the maximum tolerable and feasible dose of EOC for parPi veliparib combined chemotherapy treatmentphase I, dose-restrictive toxicity (DLTs) for the 1-2 cycle was assessed for a dose-restrictive dose upgrade of 3-3Once DLT appears in 2/6 patients, the dose level expands to assess the feasibility of 4 cyclesThe study began in October 2009 and ended in August 2016Eligible patients have untreated Stage II-IV EOCDuring 6 cycles of chemotherapy, Veliparib is added continuously (days 1-21) or intermittently (2-5 days)Three chemotherapy backbones (2 intravenous injections (q3week and weekly) and 1 peritoneal (IP) were evaluated, all including belavite stoic and as maintained up to 22 cyclesresults, dose evaluation was obtained for 424 treated patientsScenario 1 (q3 weeks), continuous (Reg1c) maximum tolerable dose (MTD) is 250 mg veliparib BID, feasible dose is 150 mg BIDFor Scenario 1, intermittent (Reg1i) MTD and feasible doses are 400 and 250 mg BID, respectivelyFor Reg2c (weekly yew alcohol), MTD and a feasible dose of 150 mg BIDReg2i's MTD and feasible doses are 250 and 150 mg BID, respectively Reg3c (IP) MTD and feasible doses are 150 mg BID, Reg3i (IP) MTD and feasible doses are 400 mg and 300 mg BID the above, the results show that the feasible doses of Reg1c, 2c, 2i and 3c are 150 mg po BID For Reg1i and 3i, the doses are pushed to 250 mg and 300 mg po BID, respectively There was no significant difference in efficacy between continuous and intermittent drugs, indicating that higher doses may not be required for intermittent use
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