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ADAM-Afatinib Diarrhea Assessment and Management

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2015 by Boehringer Ingelheim
Information provided by (Responsible Party):
Boehringer Ingelheim Identifier:
First received: March 4, 2013
Last updated: March 8, 2015
Last verified: March 2015

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.

Condition Intervention Phase
Carcinoma, Non-Small-Cell Lung
Drug: afatinib
Drug: loperamide
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:

Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Occurence of CTCAE Grade >= 2 diarrhea [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to initial onset of diarrhea grade 2 or higher [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: No ]
  • Duration of diarrhea grade 2 or higher [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: No ]
  • Changes in intensity of diarrhea over time [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: April 2013
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Afatinib with diarrhea management
afatinib starting 40 mg daily; Cohort 1 will receive loperamide at first sign of diarrhea; Cohort 2 will receive loperamide starting C1D1.
Drug: afatinib
Daily treatment starting 40 mg per day
Drug: loperamide
Follow cohort assignment and diarrhea management guidelines


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion criteria:

  1. Pathologically confirmed diagnosis of Stage IIIB or Stage IV adenocarcinoma of the lung, with EGFR mutations-positive status, who are not eligible to receive surgery or chemoradiotherapy. Patients with mixed histology are eligible if adenocarcinoma is the predominant histology, and is a suitable candidate for EGFR-TKI monotherapy, in the opinion of the investigator.
  2. Patients must have Epidermal Growth Factor Receptor (EGFR) mutation-positive status according to the institutional standard of care.
  3. Patient received no more than one (1) prior chemotherapy for locally advanced or metastatic adenocarcinoma of the lung.
  4. Male or female patients Age 18 years and older.
  5. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
  6. Adequate organ function, defined as all of the following:

    • Left Ventricular Ejection Fraction (LVEF) of above 50% or within institution normal values
    • Absolute neutrophil count (ANC) above 1500 / mm3.
    • Platelet count above 75,000 / mm3.
    • Estimated creatinine clearance more than 45ml / min.
    • Total Bilirubin less than 1.5 times upper limit of (institutional/central) normal
    • Aspartate amino transferase (AST) or alanine amino transferase (ALT) less than three times the upper limit of (institutional/central) normal (ULN) (if related to liver metastases less than five times ULN).
  7. Recovered from any previous therapy related toxicity to Grade 0 or 1 at study entry
  8. Able and willing to follow diarrhea management guidelines provided under this study and to complete Diarrhea Management Worksheet as instructed.

Exclusion criteria:

  1. Chemotherapy, biological therapy or investigational agents within four weeks prior to the start of study treatment.
  2. Prior treatment with EGFR directed small molecules or antibodies.
  3. Hormonal treatment within 2 weeks prior to start of study treatment (continued use of anti-androgens and/or gonadorelin analogues for treatment of prostate cancer permitted).
  4. Major surgery within 4 weeks before starting study treatment or scheduled for surgery during the projected course of the study.
  5. Known hypersensitivity to afatinib or the excipients of any of the trial drugs.
  6. History or presence of clinically relevant cardiovascular abnormalities.
  7. Any history of or concomitant condition that, in the opinion of the Investigator, would compromise the patient¿s ability to comply with the study or interfere with the evaluation of the efficacy and safety of the test drug.
  8. Previous or concomitant invasive malignancies at other sites.
  9. Known pre-existing interstitial lung disease (ILD).
  10. Any history or presence of poorly controlled gastrointestinal disorders that could affect the absorption of the study drug.

14. Active hepatitis B infection, active hepatitis C infection and/or known HIV carrier, who are determined by the investigator as not a suitable candidate to receive EGFR-TKI treatment.

15. Patients with meningeal carcinomatosis. 16. Patients with brain or subdural metastases.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01814553

Contact: Boehringer Ingelheim Call Center 1-800-243-0127

United States, California
1200.167.01009 Boehringer Ingelheim Investigational Site Active, not recruiting
Santa Rosa, California, United States
United States, Florida
1200.167.01020 Boehringer Ingelheim Investigational Site Completed
Orlando, Florida, United States
1200.167.01018 Boehringer Ingelheim Investigational Site Completed
Port St. Lucie, Florida, United States
1200.167.01012 Boehringer Ingelheim Investigational Site Active, not recruiting
St. Petersburg, Florida, United States
United States, Illinois
1200.167.01007 Boehringer Ingelheim Investigational Site Active, not recruiting
Skokie, Illinois, United States
1200.167.01008 Boehringer Ingelheim Investigational Site Active, not recruiting
Skokie, Illinois, United States
United States, New Jersey
1200.167.01001 Boehringer Ingelheim Investigational Site Active, not recruiting
Morristown, New Jersey, United States
United States, Oregon
1200.167.01014 Boehringer Ingelheim Investigational Site Recruiting
Corvallis, Oregon, United States
United States, Tennessee
1200.167.01002 Boehringer Ingelheim Investigational Site Terminated
Chattanooga, Tennessee, United States
1200.167.01006 Boehringer Ingelheim Investigational Site Active, not recruiting
Chattanooga, Tennessee, United States
1200.167.01005 Boehringer Ingelheim Investigational Site Active, not recruiting
Nashville, Tennessee, United States
United States, Virginia
1200.167.01003 Boehringer Ingelheim Investigational Site Active, not recruiting
Richmond, Virginia, United States
Sponsors and Collaborators
Boehringer Ingelheim
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim Identifier: NCT01814553     History of Changes
Other Study ID Numbers: 1200.167
Study First Received: March 4, 2013
Last Updated: March 8, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Lung Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms processed this record on March 26, 2015