NCT03339843

Multiorgan Metabolic Imaging Response Assessment of Abemaciclib

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 85 (actual)
• Sponsor: Jules Bordet Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed description

In various solid tumour types FDG-PET/CT has been shown to identify treatment-refractory diseases with a high negative predictive value (NPV) through a whole-body quantitative assessment of treatment-induced changes in tumour glucose uptake soon after treatment initiation, before any structural changes are observed. Progress in the standardisation of FDG-PET/CT imaging and response analysis now allow its use in multicentric trials opening the possibilities for trials where treatment allocation will be based on early metabolic response. MiMe has been built on the assumption that a medication which does not induce any metabolic changes in a given clinical setting is unlikely to induce a significant benefit and does consequently not deserve further investigation as a single agent in this setting. MiMe, by assessing metabolic response early during the treatment course, will hopefully provide useful information about the drug activity in various cancer types, and about mechanisms of resistance through a potential ambitious translational research program with serial collection of circulating-tumour DNA (ct-DNA).

Conditions

• Esophageal Adenocarcinoma
• Esophagus SCC
• Cholangiocarcinoma
• Urothelial/Bladder Cancer, Nos
• Endometrial Cancer

Interventions

Type	Name	Description
DRUG	Abemaciclib	Subjects will receive 200 mg of abemaciclib orally, two times a day, during cycles of 28 days each. An early FDG-PET/CT will be performed at cycle 1 day 14 to search for any new lesions.

Timeline

• Start date: 2018-12-19
• Primary completion: 2021-11-12
• Completion: 2023-12-20
• First posted: 2017-11-13
• Last updated: 2024-03-15

Locations

11 sites across 2 countries: Belgium, France