NIPH Clinical Trials Search

Zolbetuximab-Induced Nausea and Vomiting: A multicenter interventional study

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	HER2-negative, Claudin-positive unresectable advanced or recurrent gastric cancer
Date of first enrollment	2024/08/09
Target sample size	110
Countries of recruitment	Japan
Study type	Interventional
Intervention(s)	Initiate the first administration of Zolbetuximab at 100 mg/m2/h and increase the infusion rate to 200 mg/m2/h, 300 mg/m2/h, and 400 mg/m2/h

Outcome(s)

Primary Outcome	The infusion rate at which Grade 2 or higher nausea/vomiting (requiring infusion interruption or rate adjustment) first occurs during the first cycle.
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum	20years-old
Age maximum	Not applicable
Gender	Male and Female
Include criteria
Exclude criteria	- Patients who start Zolbetuximab at a reduced dose - Patients with nausea (Grade 2) requiring antiemetic treatment at the time of registration - Patients with vomiting at the time of registration - Patients who started narcotic medications (strong opioids) within 48 hours before registration - Patients with ascites requiring therapeutic paracentesis - Patients with symptomatic brain metastasis and carcinomatous meningitis - Patients with gastrointestinal disorders such as bowel obstruction - Patients who have received radiation therapy to the abdomen (below the diaphragm) or pelvis within 6 days before registration; however, patients who have received localized radiation therapy to bone parts for bone metastases (e.g., lumbar spine) are not excluded - Patients taking certain medications within 48 hours before starting treatment - Patients otherwise deemed inappropriate for participation in this clinical study