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LUX Lung Special Access Scheme Australia Named Patient Use (NPU)

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.
ClinicalTrials.gov Identifier: NCT01209650
Recruitment Status : Approved for marketing
First Posted : September 27, 2010
Last Update Posted : November 10, 2016
Sponsor:
Information provided by (Responsible Party):

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)


Condition or disease Intervention/treatment
Carcinoma, Non-Small-Cell Lung Drug: BIBW 2992

Study Design

Study Type : Expanded Access
Official Title: Expanded Access Program BIBW 2992 for Non Small Cell Lung Cancer ( NSCLC) Last Line Treatment

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Interventions

Intervention Details:
    Drug: BIBW 2992
    tablets
Eligibility Criteria

Information from the National Library of Medicine

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01209650


Locations
Australia, New South Wales
1200.47.1 Boehringer Ingelheim Investigational Site
North Ryde, New South Wales, Australia
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
More Information

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01209650     History of Changes
Other Study ID Numbers: 1200.47
First Posted: September 27, 2010    Key Record Dates
Last Update Posted: November 10, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases