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

Status:

APPROVED_FOR_MARKETING

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

Lead Sponsor:

Boehringer Ingelheim

Conditions:

Carcinoma, Non-Small-Cell Lung

Eligibility:

All Genders

18+ years

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 Pr...

Eligibility Criteria

Inclusion

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

Exclusion

Key Trial Info

Start Date :

Trial Type :

EXPANDED_ACCESS

End Date :

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT01209650

Last Update

November 10 2016

Active Locations (1)

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