Multiorgan Metabolic Imaging Response Assessment of Abemaciclib (MiMe-A)
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|ClinicalTrials.gov Identifier: NCT03339843|
Recruitment Status : Recruiting
First Posted : November 13, 2017
Last Update Posted : February 12, 2019
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:
- Platinum-refractory esophageal adenocarcinoma (ADC)
- Platinum-refractory esophageal squamous cell carcinoma (SCC)
- Platinum-refractory cholangiocarcinoma
- Platinum-refractory and progressive after immunotherapy urothelial cancer
- Platinum-refractory endometrial cancer
|Condition or disease||Intervention/treatment||Phase|
|Esophageal Adenocarcinoma Esophagus SCC Cholangiocarcinoma Urothelial/Bladder Cancer, Nos Endometrial Cancer||Drug: Abemaciclib||Phase 2|
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).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||85 participants|
|Intervention Model:||Sequential Assignment|
|Intervention Model Description:||This is a two step, open-label, basket trial looking at 5 different tumour types.|
|Masking:||None (Open Label)|
|Official Title:||Multiorgan Metabolic Imaging Response Assessment of Abemaciclib|
|Actual Study Start Date :||December 19, 2018|
|Estimated Primary Completion Date :||October 15, 2021|
|Estimated Study Completion Date :||October 15, 2021|
This study contains 2 stages; during the 1st stage, a maximum of 17 patients will be enrolled in each tumour type cohort. After 13 evaluable patients have been enrolled, an interim analysis will be performed. If 3 or more patients are seen to have experienced a treatment success, then the cohort will pass into the 2nd stage in which a maximum of 20 more patients are enrolled. If 2 or less patients are seen to have experienced a treatment success, then that cohort will be closed and will not proceed into the 2nd stage.
Subjects will receive 200 mg of abemaciclib orally, twice a day, during cycles of 28 days each. The subject will undergo: A baseline FDG-PET/CT and a baseline CT scan and A blinded early FDG-PET/CT at D14 +/- 2 days of study treatment.
A treatment success is defined as a patient who has metabolic response according to PERCIST with a response cut off set at 15% at the early FDG-PET/CT and a morphological disease control after 2 cycles measured by RECIST v1.1.
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.
Other Name: FDG-PET/CT
- 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). [ Time Frame: 2 months ]Therapy success rate defined as: PERCIST 15%-assessed Metabolic Response at early FDG-PET/CT (D12-D16)
- 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. [ Time Frame: 2 Months ]Therapy success rate defined as: RECISTv1.1-assessed Disease Control (DC) after 2 treatment cycles (CR or PR or SD)
- Evaluate Progression-free survival (PFS define as the time from treatment start until disease progression or death) at 24 weeks from treatment start [ Time Frame: 6 months ]RECIST v1.1-based radiological response assessment performed at 24 weeks from the treatment start to determine the PFS
- Evaluate Overall Survival (OS defined as the time from treatment start until death) at 24 weeks from treatment start [ Time Frame: 6 months ]RECIST v1.1-based radiological response assessment performed at 24 weeks from the treatment start to determine the OS.
- To evaluate median progression-free survival (PFS) [ Time Frame: 42 months ]Progression Free Survival
- Evaluate median overall survival (OS) [ Time Frame: 42 months ]Overall Survival
- To evaluate toxicity profile [ Time Frame: 6 months ]Toxicity profile according to CTCAE version 4.03
- Evaluate the correlation of early metabolic response using FDG-PET/CT with morphological response to treatment assessed by RECIST [ Time Frame: 6 months ]RECIST v1.1-based radiological response assessment performed at 24 weeks from the treatment start to determine the PFS and OS
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03339843
|Contact: Laura Polastro, MDfirstname.lastname@example.org|
|Institut Jules Bordet||Recruiting|
|Bruxelles, Belgium, 1000|
|Contact: Alain Hendlisz, MD|
|Algemeen Ziekenhuis Groeninge||Not yet recruiting|
|Kortrijk, Belgium, 8500|
|Contact: Philippe Vergauwe, MD|
|CHC Saint-Joseph||Not yet recruiting|
|Liège, Belgium, 4000|
|Contact: Gauthier Demolin, MD|
|CHU Ambroise Paré||Recruiting|
|Mons, Belgium, 7000|
|Contact: Stephane Holbrechts, MD|
|CHU UCL Namur Sainte-Elisabeth||Recruiting|
|Namur, Belgium, 5000|
|Contact: Peter Vuylsteke, MD|
|Study Chair:||Laura Polastro, MD||Jules Bordet Institute|