Multiorgan Metabolic Imaging Response Assessment of Abemaciclib

Summary

Open-label, phase II, basket trial. This trial is a screening program for abemaciclib efficacy in multiple platinum-resistant tumour types by using metabolic imaging (PERCIST) and RECIST v1.1 criteria. Based on the rate of FDG-avidity and the absence of deactivation of the Rb gene function in more than 95% of cases, we propose to define 5 tumour types of interest in a preliminary stage: 1. Platinum-refractory esophageal adenocarcinoma (ADC) 2. Platinum-refractory esophageal squamous cell carcinoma (SCC) 3. Platinum-refractory cholangiocarcinoma 4. Platinum-refractory and progressive after immunotherapy urothelial cancer 5. Platinum-refractory endometrial cancer

Timeline

Start

2018-12-19

Primary completion

2021-11-12

Completion

2023-12-20

Drugs

Indications