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

NCT02747953 | Completed Phase 2

• 1 other identifier: 2011-09-011
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• response rate

  6 months

Study Arms (1)

afatinib

EXPERIMENTAL

Drug: Gilotrif

Interventions

Gilotrif DRUG

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.

Also known as: Afatinib

afatinib

Eligibility Criteria

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

You may qualify if:

• 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
• 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.
• No further treatment option is available.
• Male and female patients age ≥18 years.
• Written informed consent that is consistent with International Conference on Harmonisation-Good Clinical Practice (ICH-GCP) guidelines and local law.

You may not qualify if:

• Significant or recent acute gastrointestinal disorders with diarrhoea as a major symptom.
• Patients who have any other life-threatening illness or organ system dysfunction, which in the opinion of the investigator, would compromise patient safety.
• 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).
• 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).
• Bilirubin ≥1.5 mg/dl
• Serum creatinine ≥ 1.5 times of the upper normal limit or calculated/measured creatine clearance ≤ 45ml/min
• 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.
• Pregnancy or breast feeding.
• Pre-existing Interstitial Lung Disease (ILD).
• Patients suitable to be included into afatinib clinical trials

Sponsors & Collaborators

• Samsung Medical Center: lead

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 Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 22, 2013
• First Posted: April 22, 2016
• Study Start: July 1, 2011
• Primary Completion: December 1, 2014
• Study Completion: November 1, 2016
• Last Updated: March 19, 2021

Record last verified: 2021-03