Exposure driven dose escalation design with overdose control: Concept and first real life experience in an oncology phase I trial.

Micallef, Sandrine; Sostelly, Alexandre; Zhu, Jiawen; Baverel, Paul G; Mercier, Francois

Micallef, Sandrine; Sostelly, Alexandre; Zhu, Jiawen; Baverel, Paul G; Mercier, Francois.

Afiliação

Micallef S; Clinical Pharmacology, F. Hoffmann-La Roche AG, Basel, Switzerland.
Sostelly A; Clinical Pharmacology, F. Hoffmann-La Roche AG, Basel, Switzerland.
Zhu J; Biostatistics, Genentech, Inc., San Francisco, USA.
Baverel PG; Clinical Pharmacology, F. Hoffmann-La Roche AG, Basel, Switzerland.
Mercier F; Biostatistics, F. Hoffmann-La Roche AG, Basel, Switzerland.

Contemp Clin Trials Commun ; 26: 100901, 2022 Apr.

Article em En | MEDLINE | ID: mdl-35198796

Palavras-chave

Adaptive designs; Bayesian inferences; Bayesian logistic regression model, BLRM; Continual Reassessment Method, CRM; Escalation With Overdose Control, EWOC; Escalation with overdose control (EWOC); Exposure; First Order Conditional Estimation, FOCE; Population pharmacokinetic modeling; area under the concentration-time curve, AUC; dose limiting toxicity, DLT; exposure-driven EWOC, ED-EWOC; maximum tolerated dose, MTD; once every 3 weeks, Q3W; pharmacodynamic, PD; pharmacokinetic, PK

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Texto completo: 1 Base de dados: MEDLINE Tipo de estudo: Clinical_trials / Guideline Idioma: En Ano de publicação: 2022 Tipo de documento: Article

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Texto completo: 1 Base de dados: MEDLINE Tipo de estudo: Clinical_trials / Guideline Idioma: En Ano de publicação: 2022 Tipo de documento: Article