drugset / Trial / NCT01814553

ADAM-Afatinib Diarrhea Assessment and Management

NCT01814553

Phase 3 Completed 40 enrolled Boehringer Ingelheim
Parallel-groupOpen-labelTreatment

Summary

This is a non-randomized, open label, two-cohort, multi-institutional study to evaluate the use of diarrheal management tools intended to facilitate timely intervention and treatment modifications due to afatinib treatment-related diarrhea in patients with EGFR mutations-positive adenocarcinoma of the lung. Patients in Cohort 1 will follow diarrhea management. Patients in Cohort 2 will receive prophylactic loperamide starting the fist day of afatinib treatment.

Timeline

Start
2013-04
Primary completion
2015-07
Completion
2015-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Afatinib Small molecule 40 mg
Subject Loperamide Small molecule