Afatinib Expanded Access Program

NCT01649284 | Unknown

• 1 other identifier: 1200.45
• Study Type: expanded_access
• Target: N/A
• Locations: 1 country
• Sites: 66

Brief Summary

This is an open-label, multi-center, single-arm trial, designed to provide early access to afatinib and to provide additional information on the safety and efficacy of afatinib in advanced NSCLC patients who harbor an EGFR mutation.

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

afatinib DRUG

40, 30, and 20 mg film-coated tablets

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with:
• locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC)
• Epidermal Growth Factor Receptor (EGFR) mutation-positive result per the institution's testing methodology.
• male or female patients age \>=18 years
• Adequate organ function, defined as all of the following:
• Left Ventricular Ejection Fraction (LVEF) \>50% or within institution normal values
• Absolute Neutrophil Count (ANC) \> 1500/mm3.
• Platelet count \>75,000/mm3
• Serum creatinine \< 1.5 times of the upper limit of normal
• Total Bilirubin \< 1.5 times upper limit of (institutional) normal.
• Aspartate Amino Transferase (AST) or Alanine Amino Transferase (ALT) \< three times the upper limit of (institutional) normal (ULN).
• ECOG score between 0 - 2
• written informed consent by patient or guardian prior to admission into the trial that is consistent with International Conference on Harmonisation (ICH)- Good Clinical Practice (GCP) guidelines and local law.

You may not qualify if:

• Patients who or with:
• hormonal anti-cancer treatment within 2 weeks prior to start of trial treatment (continued use of anti-androgens and/or gonadorelin analogues for treatment of prostate cancer permitted)
• Radiotherapy within 14 days prior to drug administration, except as follows:
• Palliative radiation to organs other than chest may be allowed up to 2 weeks prior to drug administration, and
• Single dose palliative treatment for symptomatic metastasis outside above allowance to be discussed with sponsor prior to enrolling.
• major surgery within 4 weeks before starting trial treatment or scheduled for surgery during the projected course of the trial
• known hypersensitivity to afatinib or any of its excipients
• history or presence of clinically relevant cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure New York Heart Association (NYHA) classification of 3, unstable angina or poorly controlled arrhythmia as determined by the treating physician. Myocardial infarction within 6 months prior to starting trial treatment.
• are Women of Child-Bearing Potential (WOCBP) and men who are able to father a child, unwilling to be abstinent or use adequate contraception prior to trial entry, for the duration of trial participation and for at least 2 weeks after treatment has ended.
• childbearing potential who are: a) are nursing or b) are pregnant or c) are not using an acceptable method of birth control, or do not plan to continue using this method throughout the trial and/or do not agree to submit to pregnancy testing required by this protocol
• any history of or concomitant condition that, in the opinion of the treating physician, would compromise the patient's ability to comply with the trial or interfere with the evaluation of safety for the trial drug
• previous or concomitant malignancies at other sites, except effectively treated non-melanoma skin cancers, carcinoma in situ of the cervix, ductal carcinoma in situ or effectively treated malignancy that has been in remission for more than 3 years and is considered to be cured.
• requiring treatment with any of the prohibited concomitant medications listed in Section 4.2.2 of the protocol that can not be stopped for the duration of trial participation
• known pre-existing interstitial lung disease
• presence of poorly controlled gastrointestinal disorders that could affect the absorption of the trial drug based on treating physician assessment.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (66)

1200.45.004 Boehringer Ingelheim Investigational Site

Mobile, Alabama, United States

Location

1200.45.116 Boehringer Ingelheim Investigational Site

Goodyear, Arizona, United States

Location

1200.45.057 Boehringer Ingelheim Investigational Site

Hot Springs, Arkansas, United States

Location

1200.45.078 Boehringer Ingelheim Investigational Site

Anaheim, California, United States

Location

1200.45.114 Boehringer Ingelheim Investigational Site

Burbank, California, United States

Location

1200.45.123 Boehringer Ingelheim Investigational Site

Glendale, California, United States

Location

1200.45.115 Boehringer Ingelheim Investigational Site

Lakewood, California, United States

Location

1200.45.117 Boehringer Ingelheim Investigational Site

Long Beach, California, United States

Location

1200.45.102 Boehringer Ingelheim Investigational Site

Monterey, California, United States

Location

1200.45.091 Boehringer Ingelheim Investigational Site

Pleasant Hill, California, United States

Location

1200.45.098 Boehringer Ingelheim Investigational Site

Pleasant Hill, California, United States

Location

1200.45.006 Boehringer Ingelheim Investigational Site

Ranco Cucamonga, California, United States

Location

1200.45.003 Boehringer Ingelheim Investigational Site

Southington, Connecticut, United States

Location

1200.45.007 Boehringer Ingelheim Investigational Site

Stamford, Connecticut, United States

Location

1200.45.026 Boehringer Ingelheim Investigational Site

Hollywood, Florida, United States

Location

1200.45.097 Boehringer Ingelheim Investigational Site

Hollywood, Florida, United States

Location

1200.45.017 Boehringer Ingelheim Investigational Site

Jacksonville, Florida, United States

Location

1200.45.058 Boehringer Ingelheim Investigational Site

Jacksonville, Florida, United States

Location

1200.45.016 Boehringer Ingelheim Investigational Site

Lakeland, Florida, United States

Location

1200.45.103 Boehringer Ingelheim Investigational Site

Miami Beach, Florida, United States

Location

1200.45.037 Boehringer Ingelheim Investigational Site

Orlando, Florida, United States

Location

1200.45.056 Boehringer Ingelheim Investigational Site

Port Saint Lucie, Florida, United States

Location

1200.45.119 Boehringer Ingelheim Investigational Site

Titusville, Florida, United States

Location

1200.45.095 Boehringer Ingelheim Investigational Site

Alpharetta, Georgia, United States

Location

1200.45.029 Boehringer Ingelheim Investigational Site

Athens, Georgia, United States

Location

1200.45.042 Boehringer Ingelheim Investigational Site

Macon, Georgia, United States

Location

1200.45.121 Boehringer Ingelheim Investigational Site

Valdosta, Georgia, United States

Location

1200.45.024 Boehringer Ingelheim Investigational Site

Decatur, Illinois, United States

Location

1200.45.009 Boehringer Ingelheim Investigational Site

Evanston, Illinois, United States

Location

1200.45.099 Boehringer Ingelheim Investigational Site

Peoria, Illinois, United States

Location

1200.45.040 Boehringer Ingelheim Investigational Site

Waterloo, Iowa, United States

Location

1200.45.041 Boehringer Ingelheim Investigational Site

Wichita, Kansas, United States

Location

1200.45.083 Boehringer Ingelheim Investigational Site

Marrero, Louisiana, United States

Location

1200.45.087 Boehringer Ingelheim Investigational Site

Metairie, Louisiana, United States

Location

1200.45.019 Boehringer Ingelheim Investigational Site

Columbia, Maryland, United States

Location

1200.45.039 Boehringer Ingelheim Investigational Site

Rockville, Maryland, United States

Location

1200.45.053 Boehringer Ingelheim Investigational Site

Ann Arbor, Michigan, United States

Location

1200.45.046 Boehringer Ingelheim Investigational Site

Detroit, Michigan, United States

Location

1200.45.100 Boehringer Ingelheim Investigational Site

Jackson, Mississippi, United States

Location

1200.45.067 Boehringer Ingelheim Investigational Site

St Louis, Missouri, United States

Location

1200.45.071 Boehringer Ingelheim Investigational Site

Billings, Montana, United States

Location

1200.45.021 Boehringer Ingelheim Investigational Site

Omaha, Nebraska, United States

Location

1200.45.066 Boehringer Ingelheim Investigational Site

Freehold, New Jersey, United States

Location

1200.45.105 Boehringer Ingelheim Investigational Site

Albuquerque, New Mexico, United States

Location

1200.45.080 Boehringer Ingelheim Investigational Site

Brooklyn, New York, United States

Location

1200.45.068 Boehringer Ingelheim Investigational Site

Fresh Meadows, New York, United States

Location

1200.45.051 Boehringer Ingelheim Investigational Site

New York, New York, United States

Location

1200.45.092 Boehringer Ingelheim Investigational Site

New York, New York, United States

Location

1200.45.001 Boehringer Ingelheim Investigational Site

Charlotte, North Carolina, United States

Location

1200.45.086 Boehringer Ingelheim Investigational Site

Bismarck, North Dakota, United States

Location

1200.45.048 Boehringer Ingelheim Investigational Site

Minot, North Dakota, United States

Location

1200.45.090 Boehringer Ingelheim Investigational Site

Canton, Ohio, United States

Location

1200.45.005 Boehringer Ingelheim Investigational Site

Columbus, Ohio, United States

Location

1200.45.089 Boehringer Ingelheim Investigational Site

Tulsa, Oklahoma, United States

Location

1200.45.094 Boehringer Ingelheim Investigational Site

Portland, Oregon, United States

Location

1200.45.020 Boehringer Ingelheim Investigational Site

Hershey, Pennsylvania, United States

Location

1200.45.096 Boehringer Ingelheim Investigational Site

Johnstown, Pennsylvania, United States

Location

1200.45.060 Boehringer Ingelheim Investigational Site

Philadelphia, Pennsylvania, United States

Location

1200.45.085 Boehringer Ingelheim Investigational Site

Pottstown, Pennsylvania, United States

Location

1200.45.120 Boehringer Ingelheim Investigational Site

Rapid City, South Dakota, United States

Location

1200.45.049 Boehringer Ingelheim Investigational Site

Cookeville, Tennessee, United States

Location

1200.45.113 Boehringer Ingelheim Investigational Site

El Paso, Texas, United States

Location

1200.45.045 Boehringer Ingelheim Investigational Site

Fairfax, Virginia, United States

Location

1200.45.076 Boehringer Ingelheim Investigational Site

Seattle, Washington, United States

Location

1200.45.093 Boehringer Ingelheim Investigational Site

Charleston, West Virginia, United States

Location

1200.45.125 Boehringer Ingelheim Investigational Site

Wausau, Wisconsin, United States

Location

Related Publications (1)

• Kim ES, Halmos B, Kohut IF, Patel T, Rostorfer RD, Spira AI, Cseh A, McKay J, Wallenstein G, Mileham KF. Efficacy and Safety Results of the Afatinib Expanded Access Program. Oncol Ther. 2017;5(1):103-110. doi: 10.1007/s40487-017-0043-5. Epub 2017 Apr 10.

  PMID: 28680960 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Afatinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Amides; Organic Chemicals; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2012
• First Posted: July 25, 2012
• Study Start: July 1, 2012
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: November 30, 2016

Record last verified: 2015-03

Locations

US (66)