Neoplasms

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Symptoms and General Pathology

Rare Diseases

Carcinoma

Adenocarcinoma

Carcinoma, Non-Small-Cell Lung

Diarrhea

Adenocarcinoma of Lung

Signs and Symptoms, Digestive

Carcinoma, Bronchogenic

Bronchial Neoplasms

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Lung Adenocarcinoma

Gastrointestinal Agents

All Drugs and Chemicals

Antineoplastic Agents

Amino Acids

Loperamide

Afatinib

Antidiarrheals

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

afatinib starting 40 mg daily; Cohort 1 will receive loperamide at first sign of diarrhea; Cohort 2 will receive loperamide starting C1D1.

afatinib

Follow cohort assignment and diarrhea management guidelines

loperamide

Boehringer Ingelheim

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.

ADAM-Afatinib Diarrhea Assessment and Management

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)

Overall incidence of patients who experienced diarrhea during the first three courses of afatinib treatment.

Time to initial onset of diarrhea grade 2 or higher

Duration of first episode of diarrhea grade 2 or higher.

Please note that the nine patients experienced diarrhea episodes that were not managed according to the protocol specified afatinib treatment interruptions and dose reductions. No patients were excluded from the primary analysis.

Percentage of participants with grade 2 or higher diarrhea each week for the first 3 cycles of afatinib treatment

Progression-free survival (PFS). PFS was defined as the time from the start of treatment to an event occurred. In the analyses for the PFS endpoint, an event was defined as disease progression or death, whichever occurred earlier. Data for patients who did not die or progress during the trial were censored at the time of afatinib discontinuation or transition to commercially available afatinib. Median PFS is estimated using Kaplan-Meier method.

Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST 1.1).

Subjects were orally administered with the starting dose of Afatinib Film-coated tablets 40 mg once daily - with possible dose reductions to 30 mg and 20 mg and if any diarrhea was experienced Common Terminology Criteria for Adverse Events (CTCAE Grade 1), 2 tablets of loperamide 2 mg were to be taken immediately, followed by 1 tablet of loperamide 2 mg with every subsequent loose bowel movement until bowel movements ceased for 12 hours.

Afatinib 40 mg + Loperamide (Cohort 1)

Subjects were orally administered with the starting dose of Afatinib Film-coated tablets 40 mg once daily - with possible dose reductions to 30 mg and 20 mg and 2 tablets of loperamide 2 mg daily (i.e., 4 mg daily) starting on Course 1 Day 1. If any diarrhea was experienced (CTCAE Grade 1) by subjects, 2 tablets of loperamide 2 mg were to be taken immediately, followed by 1 tablet of loperamide 2mg with every subsequent loose bowel movement until bowel movements ceased for 12 hours. Subjects who experienced no diarrhea during Course 1 were allowed to reduce the loperamide dose to 2 mg daily and subjects who experienced no diarrhea during the first two courses discontinued daily prophylactic loperamide at the end of Course 2.

Afatinib 40 mg + Loperamide Prophylactic (Cohort 2)

Total

Age, Continuous

Sex: Female, Male

Treated Set : This analysis set includes all entered patients who received at least one dose of investigational treatment (afatinib) and for whom there was documentation that they took at least 1 dose.

In this study, Nine patients experienced diarrhea episodes that were not managed according to the protocol specified afatinib treatment interruptions and dose reductions. No patients were excluded from the primary analysis.

Boehringer Ingelheim, Call Center

Occurence of CTCAE Grade >= 2 Diarrhea

Time to Initial Onset of Diarrhea Grade 2 or Higher

Duration of First Episode of Diarrhea Grade 2 or Higher

Grade 2: Week 1 (N=2, 1)

Grade 2: Week 2 (N=4, 3)

Grade 2: Week 3 (N=3, 3)

Grade 2: Week 4 (N=6, 2)

Grade 2: Week 5 (N=2, 0)

Grade 2: Week 6 (N=0, 1)

Grade 2: Week 7 (N=2, 1)

Grade 2: Week 8 (N=3, 0)

Grade 2: Week 9 (N=2, 0)

Grade 2: Week 10 (N=0, 0)

Grade 2: Week 11 (N=2, 0)

Grade 2: Week 12 (N=1, 1)

Grade >=3: Week 1 (N=1, 1)

Grade >=3: Week 2 (N=2, 2)

Grade >=3: Week 3 (N=3, 1)

Grade >=3: Week 4 (N=0, 1)

Grade >=3: Week 5 (N=0, 0)

Grade >=3: Week 6 (N=0, 0)

Grade >=3: Week 7 (N=1, 0)

Grade >=3: Week 8 (N=0, 0)

Grade >=3: Week 9 (N=0, 0)

Grade >=3: Week 10 (N=1, 0)

Grade >=3: Week 11 (N=0, 0)

Grade >=3: Week 12 (N=0, 0)

Changes in Intensity of Diarrhea Over Time

Overall Study

Spots Global Cancer Trial Database for ADAM-Afatinib Diarrhea Assessment and Management

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial