Maintenance With Niraparib In Patients With Advanced Urothelial Cancer After 1st-line Platinum-based Chemotherapy

"Niraparib will be administered as a flat-fixed, continuous daily dose:~≥77 kg and ≥150,000 µL: 300 mg (3 X 100 mg capsules) daily \<77 kg or \<150,000 µL: 200 mg (2 X 100 mg capsules) daily\*~\* For patients whose starting dose is 2 capsules once daily, escalation to 3 capsules once daily will be permitted if no treatment interruption or discontinuation will be required during the first 2 cycles of therapy"

"In both treatment arms, Best Supportive Care (BSC) is defined as a comprehensive assessment of symptoms, with timely application of symptom control measures, in order to maximize patient's quality of life.~BSC does not include any active antitumoral treatment, and will be given according to local guidelines and the normal practice of each participating institution.~BSC will include use of opioid analgesics, other supportive drugs, radiotherapy, administered with the exclusive aim of improving tumor symptoms (e.g. pain, haematuria, etc.), according to Investigator's judgment."