Multiorgan Metabolic Imaging Response Assessment of Abemaciclib
Belgium85 participantsStarted 2018-12-19
Plain-language 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
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Age ≥ 18 years old
✓. Female or male
✓. ECOG performance status ≤ 1
✓. Life expectancy of greater than 12 weeks
✓. Must have histologically confirmed cancer corresponding to the predefined tumour subtypes (esophageal adenocarcinoma, esophageal squamous cell carcinoma, cholangiocarcinoma, urothelial cancer (progressive after immunotherapy), endometrial cancer) and metastatic or non-resectable and refractory to standard platinum regimens (and progressive after immunotherapy for the urothelial cancer).
✓. Presence of at least one metabolically measurable tumour lesion on FDG-PET/CT, according to PERCIST. If previously irradiated, must have been more than 2 months before the baseline FDG PET/CT.
✓. Measurable disease according to RECIST v 1.1
✓. Serum pregnancy test (for subjects of childbearing potential) negative
Exclusion criteria
✕
What they're measuring
1
Evaluate the anti-tumour activity of abemaciclib in the five tumour types studied in this trial using FDG-PET/CT during the first cycle of therapy (early FDG- PET/CT).
Timeframe: 2 months
2
Evaluate the anti-tumour activity of abemaciclib in the five tumour types studied in this trial using RECISTv1.1 after 2 cycles of therapy as a screening tool.
. Subjects meeting one of the following criteria are not eligible for this studyParticipants who have had chemotherapy, radiotherapy, immunotherapy, or targeted therapy within 3 weeks prior study enrolment
✕. Participants receiving concomitantly any other experimental agents
✕. Patients who have received prior therapy with other CDK4/6 inhibitors
✕. Subjects with known brain metastasis; unless the metastasis are asymptomatic and have been stable since at least 2 months prior to treatment start.
✕. Patient with meningeal carcinomatosis
✕. Have had major surgery within 28 days prior to the start of the treatment to allow for post-operative healing of the surgical wound
✕. History of allergic reactions attributed to compounds of similar chemical or biologic composition
✕. Bleeding diathesis, thromboembolic event, history of cardiovascular ischemic disease or cerebrovascular incident within the last six months