Trial record 13 of 30 for:    cancer | First posted from 04/22/2016 to 04/22/2016

Gilotrif (Afatinib) in Advanced Non-Small Cell Lung Cancer Patients Pre-treated With Erlotinib or Gefitinib

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02747953
Recruitment Status : Completed
First Posted : April 22, 2016
Last Update Posted : April 22, 2016
Information provided by (Responsible Party):
Keunchil Park, Samsung Medical Center

Brief Summary:

The program will provide early access to the investigational drug gilotrif in patients with advanced non-small cell lung cancer who have failed at least 6 months on erlotinib or gefitinib.

The Compassionate Use Programme will also provide additional safety information on gilotrif use.

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Drug: Gilotrif Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label Compassionate Use Programme of Gilotrif (Afatinib) in Advanced Non-Small Cell Lung Cancer Patients Pre-treated With Erlotinib or Gefitinib
Study Start Date : July 2011
Actual Primary Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: afatinib Drug: Gilotrif
50 mg with an option to reduce the dose to 40mg or 30 mg once a day Continuous daily dosing, one course consists of 28 days. Patients are eligible for repeated treatment courses in the absence of disease progression and undue toxicity.
Other Name: Afatinib

Primary Outcome Measures :
  1. response rate [ Time Frame: 6 months ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Patients with pathologically confirmed diagnosis of adenocarcinoma of the lung Stage IV with progressive disease following at least one line of platinum-based cytotoxic chemotherapy
  2. Patients progressing after clinical benefit on erlotinib or gefitinib: clinical benefit is defined as stable disease for at least 6 months, or a complete or partial response, or the presence of an activating mutation of the epidermal growth factor (EGF) receptor family.
  3. No further treatment option is available.
  4. Male and female patients age ≥18 years.
  5. Written informed consent that is consistent with International Conference on Harmonisation-Good Clinical Practice (ICH-GCP) guidelines and local law.

Exclusion Criteria:

  1. Significant or recent acute gastrointestinal disorders with diarrhoea as a major symptom.
  2. Patients who have any other life-threatening illness or organ system dysfunction, which in the opinion of the investigator, would compromise patient safety.
  3. History of cardiac disease that is clinically significant, as judged by the investigator or uncontrolled cardiac disease (including congestive heart failure, angina, myocardial infarction, arrhythmia, including New York Heart Association (NYHA) functional classification of 3).
  4. Aspartate amino transferase (AST) or alanine amino transferase (ALT) ≥ three times the upper limit of normal (if related to liver metastases ≥ five times the upper limit of normal).
  5. Bilirubin ≥1.5 mg/dl
  6. Serum creatinine ≥ 1.5 times of the upper normal limit or calculated/measured creatine clearance ≤ 45ml/min
  7. Women of child-bearing potential or men who are able to father a child unwilling to use a medically acceptable method of contraception during the treatment.
  8. Pregnancy or breast feeding.
  9. Pre-existing Interstitial Lung Disease (ILD).
  10. Patients suitable to be included into afatinib clinical trials

Responsible Party: Keunchil Park, Professor, Samsung Medical Center Identifier: NCT02747953     History of Changes
Other Study ID Numbers: 2011-09-011
First Posted: April 22, 2016    Key Record Dates
Last Update Posted: April 22, 2016
Last Verified: April 2016

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Bronchial Neoplasms
Carcinoma, Non-Small-Cell Lung
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Erlotinib Hydrochloride
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action