کد مقاله کد نشریه سال انتشار مقاله انگلیسی ترجمه فارسی نسخه تمام متن
5549716 1402894 2017 3 صفحه PDF سفارش دهید دانلود کنید
عنوان انگلیسی مقاله
Innovative design for a phase 1 trial with intra-patient dose escalation: The Crotoxin study
موضوعات مرتبط
علوم پزشکی و سلامت داروسازی، سم شناسی و علوم دارویی علوم دارویی
پیش نمایش صفحه اول مقاله
Innovative design for a phase 1 trial with intra-patient dose escalation: The Crotoxin study
چکیده انگلیسی

IntroductionCrotoxin has a broad antitumor activity but has shown frequent neurotoxic toxicity. To induce tolerance and limit this toxicity, we propose a new design with intra-patient dose escalation.MethodsA new Dose Limiting Toxicity definition was used. The concept of Target Ceiling Dose was introduced.ResultsDose Limiting Toxicity was the inability to dose escalate twice. Target Ceiling Dose was the highest planned dose to be administered to a patient and could change for patients along time. Recommended Dose was defined similarly as in a (3 + 3) conventional design.ConclusionThis innovant design was used and the clinical trial is now closed for inclusions. Results will be presented later.

ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Contemporary Clinical Trials Communications - Volume 7, September 2017, Pages 186-188
نویسندگان
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