Dose finding with escalation with overdose control (EWOC) in cancer clinical trials
From MaRDI portal
(Redirected from Publication:903293)
Abstract: Traditionally, the major objective in phase I trials is to identify a working-dose for subsequent studies, whereas the major endpoint in phase II and III trials is treatment efficacy. The dose sought is typically referred to as the maximum tolerated dose (MTD). Several statistical methodologies have been proposed to select the MTD in cancer phase I trials. In this manuscript, we focus on a Bayesian adaptive design, known as escalation with overdose control (EWOC). Several aspects of this design are discussed, including large sample properties of the sequence of doses selected in the trial, choice of prior distributions, and use of covariates. The methodology is exemplified with real-life examples of cancer phase I trials. In particular, we show in the recently completed ABR-217620 (naptumomab estafenatox) trial that omitting an important predictor of toxicity when dose assignments to cancer patients are determined results in a high percent of patients experiencing severe side effects and a significant proportion treated at sub-optimal doses.
Recommendations
- Escalation with overdose control using ordinal toxicity grades for cancer phase I clinical trials
- Number of patients per cohort and sample size considerations using dose escalation with overdose control
- Incorporating a patient dichotomous characteristic in cancer phase I clinical trials using escalation with overdose control
- Incoherent dose-escalation in phase I trials using the escalation with overdose control approach
- Unifying CRM and EWOC designs for phase I cancer clinical trials
Cites work
- scientific article; zbMATH DE number 3385132 (Why is no real title available?)
- Coherence principles in dose-finding studies
- Continual Reassessment Method: A Practical Design for Phase 1 Clinical Trials in Cancer
- Dose finding in drug development.
- Optimal Bayesian-feasible dose escalation for cancer phase I trials
- Sequential Designs for Phase I Clinical Trials with Late‐Onset Toxicities
- Statistical properties of the traditional algorithm-based designs for phase I cancer clinical trials
- TWO-SAMPLE CONTINUAL REASSESSMENT METHOD
- Unifying CRM and EWOC designs for phase I cancer clinical trials
Cited in
(17)- A new design of the continual reassessment method
- A Bayesian adaptive design for dual-agent phase I-II oncology trials integrating efficacy data across stages
- A Bayesian design for phase I cancer therapeutic vaccine trials
- Unifying CRM and EWOC designs for phase I cancer clinical trials
- A continual reassessment method without undue risk of toxicity
- Incorporating a patient dichotomous characteristic in cancer phase I clinical trials using escalation with overdose control
- Incoherent dose-escalation in phase I trials using the escalation with overdose control approach
- A nonparametric Bayesian method for dose finding in drug combinations cancer trials
- Improving safety of the continual reassessment method via a modified allocation rule
- Methodology and application of adaptive and sequential approaches in contemporary clinical trials
- Number of patients per cohort and sample size considerations using dose escalation with overdose control
- Extending the continual reassessment method to accommodate step-up dosing in phase I trials
- Bayesian optimization design for finding a maximum tolerated dose combination in phase I clinical trials
- Adaptive clinical trial designs for phase I cancer studies
- Escalation with overdose control using ordinal toxicity grades for cancer phase I clinical trials
- Stochastic approximation and modern model-based designs for dose-finding clinical trials
- A Bayesian adaptive design in cancer phase I trials using dose combinations in the presence of a baseline covariate
This page was built for publication: Dose finding with escalation with overdose control (EWOC) in cancer clinical trials
Report a bug (only for logged in users!)Click here to report a bug for this page (MaRDI item Q903293)
