Two-stage model-based design of cancer phase I dose escalation trials: evaluation using the phase I program of barasertib (AZD1152)
نویسندگان
چکیده
منابع مشابه
Dose Escalation Methods in Phase I Cancer Clinical Trials
Phase I clinical trials are an essential step in the development of anticancer drugs. The main goal of these studies is to establish the recommended dose and/or schedule of new drugs or drug combinations for phase II trials. The guiding principle for dose escalation in phase I trials is to avoid exposing too many patients to subtherapeutic doses while preserving safety and maintaining rapid acc...
متن کاملA product of independent beta probabilities dose escalation design for dual-agent phase I trials
Dual-agent trials are now increasingly common in oncology research, and many proposed dose-escalation designs are available in the statistical literature. Despite this, the translation from statistical design to practical application is slow, as has been highlighted in single-agent phase I trials, where a 3 + 3 rule-based design is often still used. To expedite this process, new dose-escalation...
متن کاملsynthesis of platinum nanostructures in two phase system
چکیده پلاتین، فلزی نجیب، پایدار و گران قیمت با خاصیت کاتالیزوری زیاد است که کاربرد های صنعتی فراوانی دارد. کمپلکس های پلاتین(ii) به عنوان دارو های ضد سرطان شناخته شدند و در شیمی درمانی بیماران سرطانی کاربرد دارند. خاصیت کاتالیزوری و عملکرد گزینشی پلاتین مستقیماً به اندازه و- شکل ماده ی پلاتینی بستگی دارد. بعضی از نانو ذرات فلزی در سطح مشترک مایع- مایع سنتز شده اند، اما نانو ساختار های پلاتین ب...
The role of age on dose-limiting toxicities in phase I dose-escalation trials.
PURPOSE Elderly oncology patients are not enrolled in early-phase trials in proportion to the numbers of geriatric patients with cancer. There may be concern that elderly patients will not tolerate investigational agents as well as younger patients, resulting in a disproportionate number of dose-limiting toxicities (DLT). Recent single-institution studies provide conflicting data on the relatio...
متن کاملEfficiency of New Dose Escalation Designs in Dose-Finding Phase I Trials of Molecularly Targeted Agents
BACKGROUND Statistical simulations have consistently demonstrated that new dose-escalation designs such as accelerated titration design (ATD) and continual reassessment method (CRM)-type designs outperform the standard "3+3" design in phase I cancer clinical trials. METHODS We evaluated the actual efficiency of different dose escalation methods employed in first-in-human phase I clinical tria...
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ژورنال
عنوان ژورنال: Investigational New Drugs
سال: 2011
ISSN: 0167-6997,1573-0646
DOI: 10.1007/s10637-011-9694-5