Tokyo, June 4 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061763) titled 'ALECENSA Drug Use Surveillance' on June 2.
Study Type:
Observational
Primary Sponsor:
Institute - Chugai Pharmaceutical Co. Ltd
Condition:
Condition - To confirm the following under actual conditions of use of Alectinib Hydrochloride Capsules (hereinafter, this drug) in ALK fusion gene-positive patients with advanced or recurrent solid tumors
Non-small cell lung cancer (NSCLC) and inflammatory myofifibroblastic tumors (IMT): Safety in children (under 16 years old)
NSCLC and Non-IMT Solid Carcinomas: Efficacy and Safety
Classification by malignancy - Malignancy
Genomic information - NO
Objective:
Narrative objectives1 - To confirm the following under actual conditions of use of Alectinib Hydrochloride Capsules (hereinafter, this drug) in ALK fusion gene-positive patients with advanced or recurrent solid tumors
Non-small cell lung cancer (NSCLC) and inflammatory myofifibroblastic tumors (IMT): Safety in children (under 16 years old)
NSCLC and Non-IMT Solid Carcinomas: Efficacy and Safety
Basic objectives2 - Safety,Efficacy
Eligibility:
Age-lower limit - Not applicable
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - Non-small cell lung cancer (NSCLC) and inflammatory myofifibroblastic tumors (IMT): Safety in children (under 16 years old)
NSCLC and Non-IMT Solid Carcinomas: Efficacy and Safety
Key exclusion criteria - None
Target Size - 100
Recruitment Status:
Recruitment status - Open public recruiting
Date of protocol fixation - 2026 Year 04 Month 24 Day
Date of IRB - 2026 Year 04 Month 24 Day
Anticipated trial start date - 2026 Year 06 Month 01 Day
Last follow-up date - 2030 Year 11 Month 30 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070682
Disclaimer: Curated by HT Syndication.
