Implementing the time-to-event continual reassessment method in the presence of partial orders in a phase I head and neck cancer trial.

ABSTRACT:

Background

In this article we describe the methodology of the time-to-event continual reassessment method in the presence of partial orders (PO-TITE-CRM) and the process of implementing this trial design into a phase I trial in head and neck cancer called ADePT-DDR. The ADePT-DDR trial aims to find the maximum tolerated dose of an ATR inhibitor given in conjunction with radiotherapy in patients with head and neck squamous cell carcinoma.

Methods

The PO-TITE-CRM is a phase I trial design that builds upon the time-to-event continual reassessment method (TITE-CRM) to allow for the presence of partial ordering of doses. Partial orders occur in the case where the monotonicity assumption does not hold and the ordering of doses in terms of toxicity is not fully known.

Results

SUBMITTER: Patel A 

PROVIDER: S-EPMC10787975 | biostudies-literature | 2024 Jan

REPOSITORIES: biostudies-literature