Learning from previous responses in phase I dose-escalation studies
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 کاملDose escalation with over-dose and under-dose controls in Phase I/II clinical trials.
To save valuable time and resources in new drug development, Phase I/II clinical trials with toxicity control and drug efficacy as dual primary endpoints have become increasingly popular. Escalation with over-dose control (the EWOC) is a Bayesian adaptive Phase I clinical trial design that can accurately estimate the maximum tolerated dose (MTD) level and control the probability of overdosing p...
متن کاملA novel Bayesian method for dual-agent Phase I dose-escalation studies using penalized D-optimality
In oncology, there is increasing interest in studying combinations of drugs to improve treatment efficacy and/or reduce harmful side-effects. Dual-agent Phase I clinical trials are primarily concerned with drug safety, with the aim to discover a maximum tolerated combination dose via dose-escalation; small cohorts of patients are given set doses of both drugs and monitored to see if any particu...
متن کاملThe 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: British Journal of Clinical Pharmacology
سال: 2001
ISSN: 0306-5251
DOI: 10.1046/j.0306-5251.2001.01383.x