CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 40 enrolled
Drug / intervention
afatinib +1 moredrug
Likely dose
afatinib 40 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01814553
NCT01814553Phase 3Completed
CompareCT.gov

A Phase IIIb, Non-randomized, Open-label, Two-cohort Study in Patients With EGFR Mutations-positive Advanced Adenocarcinoma of the Lung, Assessing the Utility of the Afatinib Diarrhea Assessment and Management Guidelines (ADAM)

Boehringer Ingelheim·interventional·Posted Mar 20, 2013·Updated Oct 31, 2016

In Brief

A Phase 3 clinical trial evaluating afatinib and loperamide for Carcinoma, Non-Small-Cell Lung. Completed, enrolled 40 participants across 12 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCarcinoma, Non-Small-Cell Lung
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedMar 20, 2013
Enrollment StartApr 1, 2013
Primary CompletionJul 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 13.3 years ago

Interventions

afatinibdrug

Daily treatment starting 40 mg per day

loperamidedrug

Follow cohort assignment and diarrhea management guidelines