Clinical Trial: Exploratory Single-Arm Interventional Study of Scheduled, Continued Loperamide for Abemaciclib-Induced Diarrhea: Evaluation of Diarrhea and Impact on Daily Activities (Japan)

Tokyo, Sept. 24 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059172) titled 'Exploratory Single-Arm Interventional Study of Scheduled, Continued Loperamide for Abemaciclib-Induced Diarrhea: Evaluation of Diarrhea and Impact on Daily Activities' on Sept. 24.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Uncontrolled

Primary Sponsor: Institute - Yokohama Asahi Chuo General Hospital

Condition: Condition - Hormone Receptor-Positive, HER2-Negative Breast Cancer (Advanced/Recurrent or Adjuvant Setting) Classification by malignancy - Malignancy Genomic information - NO

Objective: Narrative objectives1 - To exploratorily evaluate the efficacy and safety of scheduled, continued loperamide administration for abemaciclib-induced diarrhea Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - When loose stools (Bristol Stool Scale type 6 or 7) occur after initiation of abemaciclib, loperamide 1 mg twice daily will be administered and continued with the same dosing schedule until Day 28, even after improvement of diarrhea.

Eligibility: Age-lower limit - 20 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - - Patients with hormone receptor-positive, HER2-negative breast cancer who are scheduled to start abemaciclib treatment - Patients aged 20 years or older - Patients with an ECOG Performance Status (PS) of 0 to 2 - Patients with no prior treatment with abemaciclib - Patients with adequate organ function, as assessed by the treating physician Key exclusion criteria - - Patients receiving concomitant medications contraindicated with abemaciclib or loperamide - Patients with active infections - Patients with infectious or hemorrhagic enteritis, or pseudomembranous colitis - Pregnant or lactating women, and women of childbearing potential who are unwilling to use effective contraception n - Patients with a history of obstructive bowel disease - Patients with inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis) or a history thereof - Patients with diarrhea of CTCAE Grade 2 or higher at baseline - Patients deemed inappropriate for study participation by the treating physician Target Size - 30

Recruitment Status: Recruitment status - Enrolling by invitation Date of protocol fixation - 2025 Year 09 Month 18 Day Date of IRB - 2025 Year 09 Month 18 Day Anticipated trial start date - 2025 Year 09 Month 24 Day Last follow-up date - 2029 Year 09 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067679

Disclaimer: Curated by HT Syndication.