Phase I oncology trials incorporating patient choice of dose
نویسندگان
چکیده
منابع مشابه
Dose expansion cohorts in Phase I trials.
A rapidly increasing number of Phase I dose-finding studies, and in particular those based on the standard 3+3 design, are being prolonged with the inclusion of dose expansion cohorts (DEC) in order to better characterize the toxicity profiles of experimental agents and to study disease-specific cohorts. These trials consist of two phases: the usual dose escalation phase that aims to establish ...
متن کاملTwo-stage dose finding for cytostatic agents in phase I oncology trials.
Conventional dose-finding methods in oncology are mainly developed for cytotoxic agents with the aim of finding the maximum tolerated dose. In phase I clinical trials with cytostatic agents, such as targeted therapies, designs with toxicity endpoints alone may not work well. For cytostatic agents, the goal is often to find the most efficacious dose that is still tolerable, although these agents...
متن کاملChoice of Starting Dose for Biopharmaceuticals in First-in-Human Phase I Cancer Clinical Trials.
BACKGROUND First-in-human (FIH) trials of low-molecular-weight anticancer agents conventionally derive a safe start dose (SD) from one-tenth the severely toxic dose in 10% of rodents or one-sixth the highest nonseverely toxic dose (HNSTD) in nonrodent species. No consensus has been reached on whether this paradigm can be safely applied to biotechnology-derived products (BDPs). MATERIALS AND M...
متن کاملIncorporating a Patient Dichotomous Characteristic in Cancer Phase I Clinical Trials Using Escalation with Overdose Control
We describe a design for cancer phase I clinical trials that takes into account patients heterogeneity thought to be related to treatment susceptibility. The goal is to estimate the maximum tolerated dose MTD given patient’s specific dichotomous covariate value. The design is Bayesian adaptive and is an extension of escalation with overdose control EWOC . We will assess the performance of this ...
متن کاملAccelerated titration designs for phase I clinical trials in oncology.
BACKGROUND Many cancer patients in phase I clinical trials are treated at doses of chemotherapeutic agents that are below the biologically active level, thus reducing their chances for therapeutic benefit. Current phase I trials often take a long time to complete and provide little information about interpatient variability or cumulative toxicity. PURPOSE Our objective was to develop alternat...
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ژورنال
عنوان ژورنال: British Journal of Cancer
سال: 2012
ISSN: 0007-0920,1532-1827
DOI: 10.1038/bjc.2012.378