Tokyo, Oct. 9 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059331) titled 'Special drug use-results survey on BALVERSA' on Oct. 8.
Study Type:
Observational
Primary Sponsor:
Institute - Janssen Pharmaceutical K.K.
Condition:
Condition - unresectable urothelial carcinoma with FGFR3 gene mutations or fusion genes that has progressed after cancer chemotherapy
Classification by malignancy - Malignancy
Genomic information - NO
Objective:
Narrative objectives1 - To investigate the occurrence of eye disorders (excluding retinal detachment and corneal disorder) and severe skin disorders (excluding hand and foot syndrome) in patients with radically unresectable urothelial carcinoma with FGFR3 gene mutation or fusion gene who have progressed after cancer chemotherapy (Hereinafter referred to as this drug) under actual use conditions.
Basic objectives2 - Safety
Eligibility:
Age-lower limit - Not applicable
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - Patients with unresectable urothelial carcinoma with FGFR3 gene mutation or fusion that has progressed after cancer chemotherapy who have received BALVERSA for the first time will be included.
Key exclusion criteria - Patients with a history of the use of BALVERSA
Target Size - 58
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2024 Year 12 Month 10 Day
Anticipated trial start date - 2025 Year 11 Month 01 Day
Last follow-up date - 2031 Year 07 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066915
Disclaimer: Curated by HT Syndication.
