Full Text View
Tabular View
No Study Results Posted
Related Studies
Single-Arm Trial of BIBW 2992 in Demographically and Genotypically Selected NSCLC Patients
This study is currently recruiting participants.
Verified by Boehringer Ingelheim Pharmaceuticals, April 2009
First Received: June 30, 2008   Last Updated: April 23, 2009   History of Changes
Sponsored by: Boehringer Ingelheim Pharmaceuticals
Information provided by: Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00730925
  Purpose

The primary objective of this open-label, single arm Phase II trial is to explore the efficacy of BIBW 2992 defined by the objective response rate (CR, PR) as determined by the RECIST criteria, in patients with advanced NSCLC Stage IIIB or IV whose tumours harbour activating mutations within exon 18 to exon 21 of the EGFR receptor, in patients with mutations in the HER2/neu receptor and in patients with EGFR FISH positive tumours with no EGFR mutations.


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

MedlinePlus related topics: Cancer
Drug Information available for: BIBW 2992
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Single Group Assignment, Safety/Efficacy Study
Official Title: A Phase II Single-Arm Trial of BIBW 2992 in Demographically and Genotypically Selected NSCLC

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:
  • objective response (CR, PR) as determined by the RECIST criteria [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • disease control, progression free survival time, overall survival time, pharmacokinetic, safety of BIBW 2992 as indicated by intensity and incidenceof adeverse events [ Time Frame: 6 months ]

Estimated Enrollment: 40
Study Start Date: June 2008
Estimated Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. patients with pathologically confirmed diagnosis of NSCLC stage IIIB/IV adeno- or bronchoalveolar carcinoma (BAC)
  2. non smokers patients or patients having smoked less than 15 pack years and who stopped smoking for at least one year before diagnosis (except for patients with her2-neu mutation)
  3. presence of activating mutation(s) in exon 18 to exon 21 of the EGFR or HER2-neu-receptor confirmed by direct DNA sequencing of NSCLC tumor tissue or increased copy number of the EGFR gene as determined by FISH analysis
  4. prior treatment up to 3 lines of chemotherapy except for HER2-neu patients (no rectrictions) no prior EGFR TKI therapy for EGFR mutation negative and FISCH positive patients
  5. patienst with at least one tumor lesion that can accurately be measured by CTscan or MRI in at least one dimension with long diameter to be recorded as > or equal to 20 mm using cinventional techniques or > or equal to 10 mm with spiral CT scan
  6. male or female patient aged above or equal to 18 years
  7. life expectancy of at least 3 months
  8. written informed consents that is consistent with ICH-GCP guidelines
  9. ECOG performance score 0, 1 or 2

Exclusion Criteria:

  1. more than 3 prior cytotoxic chemotherapy treatment regimen for relapsed or metastatic NSCLC, except for patients with HER2-neu mutations who may have received any prior therapy
  2. Any chemo-, hormone- or immunotherapy within the past 4 weeks or within less than 4 half-lives of the previous drug prior to treatment with the trial drug and/or persistence of toxicities of prior anticancer therapies which are deemed to be clinicallly relevant
  3. brain metastases which are symptomatic; patients with treated asymptomatic brain metastases are eligible with stabe brain disease for at least 4 weeks without requirement for steroids or anti-epilepyic therapy
  4. significant or recent acute gastrointestinal disorders with diarrhea as a major symptom e.g. Crohn's disease, malabsorption or CTCAE Grade > 2 diarrhea of any etiology at baseline
  5. patients who have any other life-theatening 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
  6. other malignacies diagnosed within the past 5 years (other than non melanomatous skin cancer and in situ cervical cancer)
  7. radiotherapy within the past 2 weeks prior to threatment with the trial drug
  8. patients with any serious active infection (i.e., requiring an IV antibiotic, antifungal, or antiviral agents)
  9. patients with known HIV, active hepatitis B or active hepatitis C
  10. known or suspected active drug or alcohol abuse
  11. women of chidbearing potential or men who are able to father a child unwilling to use a medically acceptable method of contraception during the trial
  12. pregnancy or breast feeding
  13. patient unable to comply with the protocol
  14. history of clinically significant or uncontrolled cardiac disease, including cogestive heart failure, angina, myocardial infarction, arrhytmia, including New York Heart Association (NYHA) functional classification of 3
  15. Cardiac left ventricular function with resting ejection fraction of less than 50% measured by multigated blood pool imaging of the heart (MUGA scan) or Echocardiogram.
  16. Absolute neutrophil count (ANC) less than 1500/mm³.
  17. Platelet count less than 100 000 / mm³.
  18. Bilirubin greater than 1.5 mg / dl (>26 µmol / L, SI unit equivalent).
  19. Aspartate amino transferase (AST) or alanine amino transferase (ALT) greater than three times the upper limit of normal (if related to liver metastases greater than five times the upper limit of normal).
  20. Serum creatinine greater than 1.5 times of the upper normal limit
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00730925

Contacts
Contact: Boehringer Ingelheim Study Coordinator 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com

Locations
Belgium
1200.41.32001 Boehringer Ingelheim Investigational Site Recruiting
Jette, Belgium
1200.41.32003 Boehringer Ingelheim Investigational Site Recruiting
Antwerpen, Belgium
1200.41.32006 Boehringer Ingelheim Investigational Site Recruiting
Namur, Belgium
1200.41.32010 Boehringer Ingelheim Investigational Site Not yet recruiting
Luxembourg, Belgium
1200.41.32008 Boehringer Ingelheim Investigational Site Recruiting
Liège, Belgium
1200.41.32009 Boehringer Ingelheim Investigational Site Not yet recruiting
Brasschaat, Belgium
1200.41.32007 Boehringer Ingelheim Investigational Site Not yet recruiting
Charleroi, Belgium
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim Pharmaceuticals
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair )
Study ID Numbers: 1200.41
Study First Received: June 30, 2008
Last Updated: April 23, 2009
ClinicalTrials.gov Identifier: NCT00730925     History of Changes
Health Authority: Belgium: Federal Agency for Medicines and Health Products

Study placed in the following topic categories:
Thoracic Neoplasms
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Non-small Cell Lung Cancer
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

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

ClinicalTrials.gov processed this record on May 07, 2009