Etude : MiMe-A /

ATTENTION : pour chaque essai clinique, les éléments affichés ci-dessous ne sont pas exhaustifs, et le protocole fourni par le promoteur reste l’unique document à consulter pour mener à bien un essai clinique sur centre. Pour plus d'informations, contactez le référent du territoire concerné.

Type d'étude
Présentation de l'étude
Acronyme : MiMe-A

Nom :

Traitement : Adjuvant

Type d'étude : Hors ciblage moléculaire

Dernière MÀJ : 24/01/2020
CIM10 - Localisation(s)
Informations principales
Titre : Multiorgan Metabolic imaging response assessment of Abemaciclib

Spécialité : Organes digestifs
Localisation : C15 - Tumeur maligne de l'oesophage

Spécialité : Organes digestifs
Localisation : C22 - Tumeur maligne du foie et des voies biliaires intrahépatiques

Spécialité : Voies urinaires
Localisation : C67 - Tumeur maligne de la vessie

Spécialité : Voies urinaires
Localisation : C65 - Tumeur maligne du bassinet

Spécialité : Voies urinaires
Localisation : C66 - Tumeur maligne de l'uretère

Spécialité : Voies urinaires
Localisation : C64 - Tumeur maligne du rein, à l'exception du bassinet

Spécialité : Voies urinaires
Localisation : C68 - Tumeur maligne des organes urinaires, autres et non précisés

Spécialité : Seins, organes génitaux de la femme
Localisation : C54 - Tumeur maligne du corps de l'utérus
Informations complémentaires
Schéma : Main objective of the trial
To evaluate the anti-tumour activity of abemaciclib in the five tumour types studied in this trial using the combination of FDG-PET/CT during the first cycle of therapy (early FDG- PET/CT) and RECIST v1.1 after 2 cycles of therapy as a screening tool.

Secondary objectives of the trial
In each tumour type population:
• To evaluate Progression-free survival (PFS define as the time from treatment start until disease progression or death) and Overall Survival (OS defined as the time from treatment start until death) at 24 weeks from treatment start,
• To evaluate median progression-free survival (PFS) and median overall survival (OS)
• To evaluate safety/toxicity profile
• To evaluate the correlation of early metabolic response using FDG-PET/CT with morphological response to treatment assessed by RECIST

Phase : II

Stade : Localement avancé à Métastasique

2, 3, 4, X
Informations libres de droit
Critères d'inclusion
Critères de non-inclusion
Informations libres de droit
Critères d'inclusion et de non-inclusion
Critères d'inclusion : 1. Age ≥ 18 years old
2. Female or Male
3. ECOG performance status ≤ 1
4. Life expectancy of greater than 12 weeks
5. 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) that are metastatic or non-resectable and refractory to standard platinum regimens (and progressive after immunotherapy for urothelial cancer if available).
6. 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.
7. Measurable disease according to RECIST v1.1
8. Negative serum pregnancy test (for subjects of childbearing potential).
9. Women of childbearing potential must agree to the use of 1 highly effective method of contraception prior to study entry, during the course of the study and at least 3 months after the last administration of study treatment.
10. Men with childbearing potential partner must agree to use a condom during the course of this study and for at least 3 months after the last administration of the study treatment.
11. Adequate coagulation: International Normalized Ratio (INR) ≤ 1.5 x ULN unless subject is receiving anticoagulant therapy as long as INR and activated partial thromboplastin time [aPTT] are within therapeutic range of intended use of anticoagulants
12. Adequate bone marrow function as defined below:
• Hemoglobin ≥ 10g/dl
• Absolute neutrophil count ≥ 1500/µL or 1.5x109/L
• Platelets ≥ 100000/µL or 100x109/L
• Leukocytes ≥ 3,000/mcL
13. Adequate liver function as defined below:
• Serum total bilirubin within 1.5 × normal institutional limits (except for Gilbert syndrome where direct bilirubin should be <1.5 institutional ULN)
• AST/ALT/ALP) levels < 3 × institutional upper normal limit (or ALT and AST <5 times upper limit of normal if liver metastases are present).
14. Adequate renal function as defined below:
• Cockcroft-Gault creatine clearance >50ml/min
15. Completion of all necessary screening procedures
16. Ability to swallow capsules
17. Grade ≤ 1 toxicity due to any previous cancer therapy according to the National Cancer Institute Common Terminology Criteria of Adverse Events (NCI-CTCAE v 5.0). Grade 2 is allowed in case of alopecia and peripheral sensory neuropathy.
18. If primary archived tumour tissue block available, it must be provided. (1 FFPE tumour tissue or 20 unstained slides)
19. Signed Informed Consent form (ICF) obtained prior to any study related procedure

Critères de non-inclusion : 1. Have had chemotherapy, radiotherapy, immunotherapy, or targeted therapy within 3 weeks prior study enrolment
2. Receiving concomitantly any other experimental agents
3. Have received prior therapy with other CDK4/6 inhibitors
4. Known brain metastasis; unless the metastasis are asymptomatic and have been stable since at least 2 months prior to treatment start.
5. Have meningeal carcinomatosis
6. Have had major surgery within 28 days prior to the start of the treatment to allow for post-operative healing of the surgical wound
7. History of allergic reactions attributed to compounds of similar chemical or biologic composition
8. Bleeding diathesis, thromboembolic event, history of cardiovascular ischemic disease or cerebrovascular incident within the last six months
9. Uncontrolled concurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia
10. Substance abuse, psychiatric illness/social situations, any psychological, familial, sociological, geographical condition, significant medical or surgical condition currently uncontrolled by treatment that would limit compliance with study requirements or interfere with the patient’s ability to understand informed consent and participation in the study
11. Pregnant and/or lactating women
12. Uncontrolled Diabetes
13. Known history of HIV infection, or active hepatitis B or C requiring treatment with anti-viral therapy
14. Have received recent (within 28 days prior the enrolment) yellow fever vaccination
15. Individuals with a history of a different malignancy are ineligible except for the following circumstances. Individuals with a history of other malignancies are eligible if they have been disease-free and are deemed by the investigator to be at low risk for recurrence of that malignancy.
Informations relatives au promoteur
Promoteur :
Institut Jules Bordet
Type de sponsor : Institutionnel
Boulevard de Waterloo 121 - 1000 Bruxelles - Belgium

Coordonnateur :
Centre investigateur
Informations relatives aux investigateurs
Centre investigateur :
Centre Henri Becquerel - Rue d'Amiens CS 11516 - Cedex 1 - 76000 ROUEN

Investigateur :
Florian CLATOT


Statut de l'essai : OUVERT

MAJ : 24/01/2020