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

Carcinoma, Non-Small-Cell Lung Clinical Trial

Official title:

Expanded Access Program BIBW 2992 for Non Small Cell Lung Cancer ( NSCLC) Last Line Treatment

Clinical Trial Details — Status: Approved for marketing

Administrative data

• NCT number: NCT01209650
• Other study ID #: 1200.47
• Status: Approved for marketing
• Phase: N/A
• First received: September 24, 2010
• Last updated: November 9, 2016

Study information

• Verified date: November 2016
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Dept of Health and Ageing Therapeutic Goods Admin
• Study type: Expanded Access

Clinical Trial 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)

Recruitment information / eligibility

• Status: Approved for marketing
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

N/A

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung

Intervention

Drug:
• BIBW 2992
tablets

Locations

Country	Name	City	State
Australia	1200.47.1 Boehringer Ingelheim Investigational Site	North Ryde	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Australia,