Debio 1143-201 Dose-finding and Efficacy Phase I/II Trial
Status:
Active, not recruiting
Trial end date:
2022-07-01
Target enrollment:
Participant gender:
Summary
The use of multiple drugs in a single clinical trial or as a therapeutic strategy has become
common, particularly in the treatment of cancer. Because traditional trials are designed to
evaluate one agent at a time, the evaluation of therapies in combination requires specialized
trial designs. In place of the traditional separate phase I and II trials, this trial uses a
single phase I/II clinical trial to evaluate simultaneously the safety and efficacy of
combination dose levels, and select the optimal combination dose.
Therefore, this is a two part trial of Debio 1143 combined with concurrent cisplatin and
radiotherapy (CRT) in participants with previously untreated stage III, IVa or IVb head and
neck cancer. The trial begins with an initial period of dose escalation (Phase I) to
investigate the maximum tolerated dose (MTD) of Debio 1143 that can safely be given in
combination with CRT.
Using the MTD determined in the Phase I portion, the randomized phase II trial in 94
participants compares Debio 1143 to placebo, both with concomitant CRT. The aim is to
evaluate the efficacy and safety of Debio 1143.