Back to resultsLUX Lung Special Access Scheme Australia Named Patient Use (NPU)
Primary Purpose
Carcinoma, Non-Small-Cell Lung
Status
Approved for marketing
Phase
Locations
Australia
Study Type
Expanded Access
Intervention
BIBW 2992
Sponsored by
About this trial
This is an expanded access trial for Carcinoma, Non-Small-Cell Lung
Eligibility Criteria
Inclusion criteria:
- Patients with pathologic confirmation of adenocarcinoma of the lung Stage IIIB with pleural effusion or Stage IV
Exclusion criteria:
- Brain metastases which are symptomatic; patients with treated, asymptomatic brain metastases are eligible with stable brain disease for at least four 4 weeks without the requirement for steroids or anti epileptic therapy
- Significant or recent acute gastrointestinal disorders with diarrhea as a major symptom as judged by the investigator.
- Patients who have any other life-threatening illness or organ system dysfunction, which in the opinion of the investigator, would either compromise patient safety or interfere with the evaluation of the safety of the test drug
- 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)
- Cardiac left ventricular function with resting ejection fraction of less than 50%
- Bilirubin 1.5 mg / dl (26 mol / L, SI unit equivalent)
- 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)
- 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 trial
- Pregnancy or breast feeding
- Patients unable to comply with the protocol
- Patients with known HIV, active hepatitis B or active hepatitis C
- Pre-existing Interstitial Lung Disease (ILD)
- Requirement for treatment with any of the prohibited concomitant medications listed in Section 4.2.2.1.
- Patients already pre-treated with BIBW 2992
Sites / Locations
- 1200.47.1 Boehringer Ingelheim Investigational Site
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT01209650
First Posted
September 24, 2010
Last Updated
November 9, 2016
Sponsor
Boehringer Ingelheim
1. Study Identification
Unique Protocol Identification Number
NCT01209650
Brief Title
LUX Lung Special Access Scheme Australia Named Patient Use (NPU)
Official Title
Expanded Access Program BIBW 2992 for Non Small Cell Lung Cancer ( NSCLC) Last Line Treatment
Study Type
Expanded Access
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Approved for marketing
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim
4. Oversight
5. Study Description
Brief Summary
The program will provide early access to the investigational drug BIBW 2992 to treat patients with advanced NSCLC who have failed at least 12 weeks on erlotinib or gefitinib.
The Compassionate Use Programme will also provide additional safety and efficacy information on BIBW 2992 use.
Named Patient Use (NPU)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Non-Small-Cell Lung
7. Study Design
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
BIBW 2992
Intervention Description
tablets
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
Patients with pathologic confirmation of adenocarcinoma of the lung Stage IIIB with pleural effusion or Stage IV
Exclusion criteria:
Brain metastases which are symptomatic; patients with treated, asymptomatic brain metastases are eligible with stable brain disease for at least four 4 weeks without the requirement for steroids or anti epileptic therapy
Significant or recent acute gastrointestinal disorders with diarrhea as a major symptom as judged by the investigator.
Patients who have any other life-threatening illness or organ system dysfunction, which in the opinion of the investigator, would either compromise patient safety or interfere with the evaluation of the safety of the test drug
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)
Cardiac left ventricular function with resting ejection fraction of less than 50%
Bilirubin 1.5 mg / dl (26 mol / L, SI unit equivalent)
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)
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 trial
Pregnancy or breast feeding
Patients unable to comply with the protocol
Patients with known HIV, active hepatitis B or active hepatitis C
Pre-existing Interstitial Lung Disease (ILD)
Requirement for treatment with any of the prohibited concomitant medications listed in Section 4.2.2.1.
Patients already pre-treated with BIBW 2992
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Organizational Affiliation
Boehringer Ingelheim
Official's Role
Study Chair
Facility Information:
Facility Name
1200.47.1 Boehringer Ingelheim Investigational Site
City
North Ryde
State/Province
New South Wales
Country
Australia
12. IPD Sharing Statement
Learn more about this trial
LUX Lung Special Access Scheme Australia Named Patient Use (NPU)
We'll reach out to this number within 24 hrs