Two-stage design for phase Ⅰ-Ⅱ cancer clinical trials using continuous dose combinations of cytotoxic agents

Tighiouart Mourad

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Two-stage design for phase Ⅰ-Ⅱ cancer clinical trials using continuous dose combinations of cytotoxic agents

机译：连续剂量组合的细胞毒剂用于Ⅰ-Ⅱ期癌症临床试验的两阶段设计

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We present a two-stage phase I-II design of a combination of two drugs in cancer clinical trials. The goal is to estimate safe dose combination regions with a desired level of efficacy. In stage I, conditional escalation with overdose control is used to allocate dose combinations to successive cohorts of patients and the maximum tolerated dose curve is estimated as a function of Bayes estimates of the model parameters. In stage II, we propose a Bayesian adaptive design for conducting the phase II trial to determine dose combination regions along the maximum tolerated dose curve with a desired level of efficacy. The methodology is evaluated by extensive simulations and application to a real trial.

机译：我们在癌症临床试验中介绍了两种药物联合使用的两阶段I-II期设计。目的是估计具有所需功效水平的安全剂量组合区域。在第I阶段，使用有剂量控制的条件升级将剂量组合分配给患者的连续队列，并根据模型参数的贝叶斯估计来估计最大耐受剂量曲线。在第二阶段，我们提出了一种贝叶斯自适应设计，用于进行第二阶段试验，以确定具有所需功效水平的最大耐受剂量曲线上的剂量组合区域。通过广泛的模拟评估该方法，并将其应用于实际试验。

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来源
《Journal of the royal statistical society》 |2019年第1期|235-250|共16页
作者
Tighiouart Mourad;
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作者单位

Cedars Sinai Med Ctr, Los Angeles, CA 90048 USA;

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原文格式 PDF
正文语种 eng
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关键词
Bayesian adaptive design; Cancer phase I-II trials; Cubic splines; Drug combination; Escalation with overdose control; Maximum tolerated dose;

机译：贝叶斯自适应设计;癌症I-II期试验;三次样条;药物组合;用过量剂量控制逐步升级;最大耐受剂量;

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1. Two-stage model-based clinical trial design to optimize phase I development of novel anticancer agents [J] . Anthe S. Zandvliet, Mats O. Karlsson, Jan H. M. Schellens, Investigational New Drugs . 2010,第1期

机译：基于模型的两阶段临床试验设计，可优化新型抗癌药的I期开发
2. Two-stage model-based clinical trial design to optimize phase I development of novel anticancer agents. [J] . Zandvliet AS, Karlsson MO, Schellens J Investigational new drugs. . 2010,第1期

机译：基于模型的两阶段临床试验设计，可优化新型抗癌药物的I期开发。
3. Cancer phase I trial design using drug combinations when a fraction of dose limiting toxicities is attributable to one or more agents [J] . Jimenez Jose L., Tighiouart Mourad, Gasparini Mauro Biometrical Journal . 2019,第2期

机译：癌症期I试验设计使用药物组合当一小部分含有限制毒性归因于一个或多个药剂时
4. The Combination of Clinical, Dose-Related and Imaging Features Helps Predict Radiation-Induced Normal-Tissue Toxicity in Lung-cancer Patients -- An in-silico Trial Using Machine Learning Techniques [C] . Nalbantov G., Dekker A., De Ruysscher D., Machine Learning and Applications and Workshops (ICMLA), 2011 10th International Conference on . 2011

机译：临床，剂量相关和影像学特征的结合可帮助预测肺癌患者放射诱发的正常组织毒性-使用机器学习技术的计算机模拟试验
5. Clinical predictive value of pre-clinical cancer models: A study of the predictive value of the in vitro cell line, human xenograft and murine allograft pre-clinical cancer models for phase II clinical trials of cytotoxic cancer drugs [D] . Voskoglou-Nomikos, Theodora 2001

机译：临床前癌症模型的临床预测价值：体外细胞系，人异种移植和小鼠同种异体移植临床前癌症模型对细胞毒性癌症药物II期临床试验的预测价值研究
6. Two-stage model-based clinical trial design to optimize phase I development of novel anticancer agents [O] . Anthe S. Zandvliet, Mats O. Karlsson, Jan H. M. Schellens, -1

机译：基于模型的两阶段临床试验设计可优化新型抗癌药的I期开发
7. Two-stage model-based clinical trial design to optimize phase I development of novel anticancer agents [O] . Anthe S. Zandvliet, Mats O. Karlsson, Jan H. M. Schellens, 2009

机译：基于模型的两阶段临床试验设计，可优化新型抗癌药的I期开发

Two-stage design for phase Ⅰ-Ⅱ cancer clinical trials using continuous dose combinations of cytotoxic agents

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