Adapting isotonic dose-finding to a dynamic set of drug combinations with application to a phase I leukemia trial.

ABSTRACT:

Background/aims

This article describes the proposed design of a phase I study evaluating the safety of ceramide nanoliposome and vinblastine among an initial set of 19 possible dose combinations in patients with relapsed/refractory acute myeloid leukemia and patients with untreated acute myeloid leukemia who are not candidates for intensive induction chemotherapy.

Methods

Extensive collaboration between statisticians and clinical investigators revealed the need to incorporate several adaptive features into the design, including the flexibility of adding or eliminating certain dose combinations based on safety criteria applied to multiple dose pairs. During the design stage, additional dose levels of vinblastine were added, increasing the dimension of the drug combination spa

SUBMITTER: Wages NA 

PROVIDER: S-EPMC8172388 | biostudies-literature | 2021 Jun

REPOSITORIES: biostudies-literature