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

Expanded access is no longer available for this treatment.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01209650
First received: September 24, 2010
Last updated: October 6, 2010
Last verified: October 2010
  Purpose

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 Intervention
Carcinoma, Non-Small-Cell Lung
Drug: BIBW 2992

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

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Study Start Date: November 2010
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: BIBW 2992
    tablets
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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:

1 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 2) Significant or recent acute gastrointestinal disorders with diarrhea as a major symptom as judged by the investigator.

3) 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 4) 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) 5) Cardiac left ventricular function with resting ejection fraction of less than 50% 6) Bilirubin 1.5 mg / dl (26 mol / L, SI unit equivalent) 7) 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) 8) Serum creatinine 1.5 times of the upper normal limit or calculated/measured creatine clearance 45ml/min 9) 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 10) Pregnancy or breast feeding 11) Patients unable to comply with the protocol 12) Patients with known HIV, active hepatitis B or active hepatitis C 13) Pre-existing Interstitial Lung Disease (ILD) 14) Requirement for treatment with any of the prohibited concomitant medications listed in Section 4.2.2.1.

15) Patients already pre-treated with BIBW 2992

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01209650     History of Changes
Other Study ID Numbers: 1200.47
Study First Received: September 24, 2010
Last Updated: October 6, 2010
Health Authority: Australia: Dept of Health and Ageing Therapeutic Goods Admin
United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on August 01, 2014