Maximum Tolerated Dose Estimate by Curve Fitting in Phase I Clinical Trial
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چکیده
منابع مشابه
A phase I trial to determine the safety, tolerability, and maximum tolerated dose of deforolimus in patients with advanced malignancies.
PURPOSE This was a phase I trial to determine the maximum tolerated dose and toxicity of deforolimus (AP23573, MK-8669), an inhibitor of mammalian target of rapamycin (mTOR). The pharmacokinetics, pharmacodynamics, and antineoplastic effects were also studied. EXPERIMENTAL DESIGN Deforolimus was administered intravenously over 30 min every 7 days according to a flat dosing schedule. Dose was ...
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The main goal of Phase-I cancer clinical trials is to find the maximum tolerated dose (MTD) of a drug for Phase-II trial for a specific mode of administration. In Phase-I trials there is a critical need to establish MTD by using minimum possible number of patients so as to avoid exposing too many patients to sub-therapeutic doses while preserving safety and maintaining rapid accrual. 3+3 is a p...
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BACKGROUND The aim of the present trial was to determine the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of liposomal cisplatin (lipoplatin) using nephrotoxicity, gastrointestinal toxicity and myelotoxicity as the main adverse reactions. PATIENTS AND METHODS Lipoplatin, a liposomal formulation of cisplatin was first tested as monotherapy starting at a dose of 125 mg/m(2) and...
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متن کاملThe impact of non-drug-related toxicities on the estimation of the maximum tolerated dose in phase I trials.
The rate of observed dose-limiting toxicities (DLT) determines the maximum tolerated dose (MTD) in phase I trials. There are cases in which non-drug-related toxicities or other-cause toxicities (OCT) are flagged as DLTs, or vice versa, due to attribution errors. We aim to assess the impact of such errors on the final estimate of MTD. We compared the impact of attribution errors using 2 trial de...
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ژورنال
عنوان ژورنال: Communications for Statistical Applications and Methods
سال: 2011
ISSN: 2287-7843
DOI: 10.5351/ckss.2011.18.2.179