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)
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 40
- Locations
- 12
- Primary Endpoint
- Occurence of CTCAE Grade >= 2 Diarrhea
Study Overview
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.
Study Design
- Study Type
- Interventional
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Afatinib 40 mg + Loperamide (Cohort 1)
afatinib starting 40 mg daily; Cohort 1 will receive loperamide at first sign of diarrhea; Cohort 2 will receive loperamide starting C1D1.
Intervention: afatinib (Drug)
Afatinib 40 mg + Loperamide (Cohort 1)
afatinib starting 40 mg daily; Cohort 1 will receive loperamide at first sign of diarrhea; Cohort 2 will receive loperamide starting C1D1.
Intervention: loperamide (Drug)
Afatinib 40 mg + loperamide prophylactic (Cohort 2)
afatinib starting 40 mg daily; Cohort 1 will receive loperamide at first sign of diarrhea; Cohort 2 will receive loperamide starting C1D1.
Intervention: afatinib (Drug)
Afatinib 40 mg + loperamide prophylactic (Cohort 2)
afatinib starting 40 mg daily; Cohort 1 will receive loperamide at first sign of diarrhea; Cohort 2 will receive loperamide starting C1D1.
Intervention: loperamide (Drug)
Outcomes
Primary Outcomes
Occurence of CTCAE Grade >= 2 Diarrhea
Time Frame: 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 Outcomes
- Time to Initial Onset 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(From first drug administration until end of third treatment course, up to 84 days.)
- Changes in Intensity of Diarrhea Over Time(Up to 12 weeks (equivalent to 3 courses))
- PFS(Every 08 weeks during the first 6 months of treatment, and every 12 weeks thereafter until the end of treatment.)