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ADAM-Afatinib Diarrhea Assessment and Management

NCT ID: NCT01814553

Last Updated: 2016-10-31

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2015-07-31

Brief Summary

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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

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Conditions

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Carcinoma, Non-Small-Cell Lung

Study Design

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Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

afatinib

Intervention Type DRUG

Daily treatment starting 40 mg per day

loperamide

Intervention Type DRUG

Follow cohort assignment and diarrhea management guidelines

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.

Group Type EXPERIMENTAL

afatinib

Intervention Type DRUG

Daily treatment starting 40 mg per day

loperamide

Intervention Type DRUG

Follow cohort assignment and diarrhea management guidelines

Interventions

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afatinib

Daily treatment starting 40 mg per day

Intervention Type DRUG

loperamide

Follow cohort assignment and diarrhea management guidelines

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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1200.167.01009 Boehringer Ingelheim Investigational Site

Santa Rosa, California, United States

Site Status

1200.167.01020 Boehringer Ingelheim Investigational Site

Orlando, Florida, United States

Site Status

1200.167.01018 Boehringer Ingelheim Investigational Site

Port Saint Lucie, Florida, United States

Site Status

1200.167.01012 Boehringer Ingelheim Investigational Site

St. Petersburg, Florida, United States

Site Status

1200.167.01007 Boehringer Ingelheim Investigational Site

Skokie, Illinois, United States

Site Status

1200.167.01008 Boehringer Ingelheim Investigational Site

Skokie, Illinois, United States

Site Status

1200.167.01001 Boehringer Ingelheim Investigational Site

Morristown, New Jersey, United States

Site Status

1200.167.01014 Boehringer Ingelheim Investigational Site

Corvallis, Oregon, United States

Site Status

1200.167.01002 Boehringer Ingelheim Investigational Site

Chattanooga, Tennessee, United States

Site Status

1200.167.01006 Boehringer Ingelheim Investigational Site

Chattanooga, Tennessee, United States

Site Status

1200.167.01005 Boehringer Ingelheim Investigational Site

Nashville, Tennessee, United States

Site Status

1200.167.01003 Boehringer Ingelheim Investigational Site

Richmond, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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1200.167

Identifier Type: -

Identifier Source: org_study_id