Multiorgan Metabolic Imaging Response Assessment of Abemaciclib

Inclusion Criteria

• •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) and metastatic or non-resectable and refractory to standard platinum regimens (and progressive after immunotherapy for the urothelial cancer).
• •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 v 1.1
• •8. Serum pregnancy test (for subjects of childbearing potential) negative
• •9. Women of childbearing potential must agree to the use a 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 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 ≥ 10 g/dL
• •* Absolute neutrophil count ≥ 1500/µL or 1.5x109/L
• •* Platelets ≥ 100000/µL or 100x109/L
• •* Leukocytes ≥ 3,000/µL
• •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 limit of normal (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.4.03). Grade 2 is allowed in case of alopecia and peripheral sensory neuropathy
• •18. Availability of primary archived tumour tissue block (1 FFPE tumour tissue)
• •19. Signed Informed Consent form (ICF) obtained prior to any study related procedure