Gilotrif (Afatinib) in Advanced Non-Small Cell Lung Cancer Patients Pre-treated With Erlotinib or Gefitinib
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|ClinicalTrials.gov Identifier: NCT02747953|
Recruitment Status : Completed
First Posted : April 22, 2016
Last Update Posted : April 22, 2016
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)|
|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|
|Primary Completion Date :||December 2014|
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
- response rate [ Time Frame: 6 months ]