A Study of MFA-370 in Patients with Metastatic Urothelial Cancer

Exclusion Criteria

• •1. Known CNS metastatic lesions, or evidence of impaired blood-brain barrier as assessed by the investigator
• •2. Have signs or symptoms of active COVID-19 infection or a positive COVID-19 Polymerase Chain Reaction (PCR) test during the screening period
• •3. Impaired renal function by estimated Glomerular Filtration Rate (eGFR) \<30 ml/min as per local assessment
• •4. Laboratory values (hematology and biochemistry) within specified ranges to show appropriate organ function
• •5. Clinically significant cardiac disease,
• •6. Untreated or uncontrolled hypertension
• •7. An underlying medical condition that precludes the ability to take oral medication daily
• •8. Prohibited concomitant therapy
• •9. The patient has had biologic, hormonal, anti-neoplastic chemotherapy, or radiation therapy other than palliative treatment within 4 weeks prior to screening except for medications with half-lives \<5.5 days
• •10. Hypersensitivity to the active ingredients or to any of the excipients listed in section 6.1 in respective Summary of Product Characteristics (SmPC)
• •11. Any bleeding disorder or condition where there is an increased risk of bleeding
• •12. A history of allergic reactions following intake of acetylsalicylic acid or NSAIDs
• •13. A history of gastrointestinal bleeding or perforation
• •14. Active or recurrent gastrointestinal ulcer
• •15. Major surgery within 14 days before enrolment. (Note: trans-urethral resection of bladder tumor is not considered major surgery)
• •16. For female patients of childbearing potential - pregnancy, as confirmed by a serum pregnancy test at screening, or breast-feeding
• •17. Any other severe, acute, or chronic medical condition that would interfere with the conduct of the study or interpretation of the study results as judged by the investigator
• •18. The patient has already participated in the study or been a screening failure