ADAM-Afatinib Diarrhea Assessment and Management

Phase 3

Completed

• Conditions: Carcinoma, Non-Small-Cell Lung
• Interventions: Drug: afatinib; Drug: loperamide

• Registration Number: NCT01814553
• Lead Sponsor: Boehringer Ingelheim

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-03-04
• Study First Submitted QC: 2013-03-18
• Study First Posted: 2013-03-20
• Study Start: 2013-04
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Results First Submitted: 2016-07-01
• Status Verified: 2016-09
• Results First Submitted QC: 2016-09-08
• Last Update Submitted: 2016-09-08
• Results First Posted: 2016-10-31
• Last Update Posted: 2016-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Afatinib 40 mg + Loperamide (Cohort 1)	afatinib	afatinib starting 40 mg daily; Cohort 1 will receive loperamide at first sign of diarrhea; Cohort 2 will receive loperamide starting C1D1.
Afatinib 40 mg + Loperamide (Cohort 1)	loperamide	afatinib starting 40 mg daily; Cohort 1 will receive loperamide at first sign of diarrhea; Cohort 2 will receive loperamide starting C1D1.
Afatinib 40 mg + loperamide prophylactic (Cohort 2)	afatinib	afatinib starting 40 mg daily; Cohort 1 will receive loperamide at first sign of diarrhea; Cohort 2 will receive loperamide starting C1D1.
Afatinib 40 mg + loperamide prophylactic (Cohort 2)	loperamide	afatinib starting 40 mg daily; Cohort 1 will receive loperamide at first sign of diarrhea; Cohort 2 will receive loperamide starting C1D1.

Primary Outcome Measures

Name	Time	Method
Occurence of CTCAE Grade >= 2 Diarrhea	From first drug administration until 28 days after the end of third treatment course, up to 84 days.	Overall incidence of patients who experienced diarrhea during the first three courses of afatinib treatment.

Secondary Outcome Measures

Name	Time	Method
Time to Initial Onset of Diarrhea Grade 2 or Higher	From first drug administration until end of third treatment course, up to 84 days.	Time to initial onset of diarrhea grade 2 or higher
Duration of First Episode of Diarrhea Grade 2 or Higher	From first drug administration until end of third treatment course, up to 84 days.	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.
Changes in Intensity of Diarrhea Over Time	Up to 12 weeks (equivalent to 3 courses)	Percentage of participants with grade 2 or higher diarrhea each week for the first 3 cycles of afatinib treatment
PFS	Every 08 weeks during the first 6 months of treatment, and every 12 weeks thereafter until the end of 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).

Trial Locations

Locations (12)

1200.167.01001 Boehringer Ingelheim Investigational Site; 🇺🇸 Morristown, New Jersey, United States

1200.167.01009 Boehringer Ingelheim Investigational Site; 🇺🇸 Santa Rosa, California, United States

1200.167.01020 Boehringer Ingelheim Investigational Site; 🇺🇸 Orlando, Florida, United States

1200.167.01003 Boehringer Ingelheim Investigational Site; 🇺🇸 Richmond, Virginia, United States

1200.167.01014 Boehringer Ingelheim Investigational Site; 🇺🇸 Corvallis, Oregon, United States

1200.167.01007 Boehringer Ingelheim Investigational Site; 🇺🇸 Skokie, Illinois, United States

1200.167.01008 Boehringer Ingelheim Investigational Site; 🇺🇸 Skokie, Illinois, United States

1200.167.01002 Boehringer Ingelheim Investigational Site; 🇺🇸 Chattanooga, Tennessee, United States

1200.167.01006 Boehringer Ingelheim Investigational Site; 🇺🇸 Chattanooga, Tennessee, United States

1200.167.01005 Boehringer Ingelheim Investigational Site; 🇺🇸 Nashville, Tennessee, United States

1200.167.01012 Boehringer Ingelheim Investigational Site; 🇺🇸 St. Petersburg, Florida, United States

1200.167.01018 Boehringer Ingelheim Investigational Site; 🇺🇸 Port St. Lucie, Florida, United States