Traditional approaches in dose-finding trials, such as the continual reassessment method,
focus on identifying the maximum tolerated dose. In contemporary early-phase dose-finding …

The use of backfill in early phase dose-finding trials is a relatively recent practice. It consists
of assigning patients to dose levels below the level where the study is at. The main reason …

In recent years, there has been increased interest in incorporation of backfilling into dose-
escalation clinical trials, which involves concurrently assigning patients to doses that have …

Background: The use of 'backfilling', assigning additional patients to doses deemed safe, in
phase I dose-escalation studies has been used in practice to collect additional information …

Background A key challenge in phase I trials is maintaining rapid escalation in order to
avoid exposing too many patients to sub-therapeutic doses, while preserving safety by …

In the two-stage continual reassessment method (CRM), model-based dose escalation is
preceded by a pre-specified escalating sequence starting from the lowest dose level. This is …

Correspondence overly toxic doses, and using small cohorts limits the numbers of patients
treated at doses below the MTD. However, the small numbers of patients treated at lower …

We consider a formal statistical design that allows simultaneous enrollment of a main cohort
and a backfill cohort of patients in a dose-finding trial. The goal is to accumulate more …

We describe a dose escalation algorithm for drug combinations in cancer phase I clinical
trials. Parametric models for describing the association between the doses and the …

With the advances in the discovery of molecular targets, there is increasing interest in
evaluating targeted therapies for disease subtypes characterized by certain biomarkers …