Patients affected by NSCLC EGFR FISH positive. MedDRA version: 9.1 Level: LLT Classification code 10061873 Term: Non-small cell lung cancer
Conditions
Interventions
Product Name: Tovok
Product Code: BIBW 2992
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: TOVOK
CAS Number: 850140-72-6
Current Sponsor code: BIBW 2992
Concentration unit: mg milligram(
Sponsors
BOEHRINGER ING.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Male and female patients aged >= 18 years. -Patients with pathologically confirmed diagnosis of NSCLC Stage IIIB (with pleural effusion) or Stage IV and histopathological classification of adeno- or bronchoalveolar carcinoma (BAC). -Increased EGFR gene copy number assessed by FISH analysis. After signed informed consent, positive result to EGFR FISH determination is mandatory to proceed to other screening assessments. -At least one tumour lesion that can accurately be measured by computed tomography (CT) or magnetic resonance imaging (MRI) in at least one dimension with longest diameter to be recorded as >=20 mm using conventional techniques or >=10 mm with spiral CT scan. -Prior chemotherapy: o 1st line patients (40 in total): no previous exposure to chemotherapy for NSCLC. Patients who received adjuvant chemotherapy and at least 12 months has elapsed since last administration of treatment will be considered 1st line. (2nd line patients (30 in total): relapse after one line of systemic treatment.In patients treated with adjuvant chemotherapy, if less than 12 months has elapsed since the last administration of treatment, patients are considered 2nd line ones, as adjuvant chemotherapy must be considered a line of treatment). -Life expectancy of at least three (3) months. -Eastern Cooperative Oncology Group (ECOG, R01-0787) performance score 0, 1 or 2. -Written informed consent that is consistent with ICH-GCP guidelines Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: -More than two (2) prior cytotoxic chemotherapy treatment regimens for NSCLC, included adjuvant chemotherapy if relapse occurred less than 12 months before. -Previous treatment with erlotinib (Tarceva), gefitinib (Iressa) or any other EGFR inhibiting small molecule or antibody. -Active brain metastases (stable 2 diarrhea of any etiology at baseline. -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. -Other malignancies diagnosed within the past five (5) years (other than non melanomatous skin cancer and in situ cervical cancer). -Radiotherapy within the past 2 weeks prior to treatment with the trial drug. -Patients with any serious active infection (i.e., requiring an IV antibiotic, antifungal, or antiviral agents). -Patients with known HIV, active hepatitis B or active hepatitis C. -Known or suspected active drug or alcohol abuse. -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. -History of clinically significant 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% measured by multigated blood pool imaging of the heart (MUGA scan) or Echocardiogram. -Absolute neutrophil count (ANC) less than 1500/mm**3. -Platelet count less than 100 000 / mm**3. -Bilirubin greater than 1.5 mg / dl (>26 micro mol / L, SI unit equivalent). 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). -Serum creatinine greater than 1.5 times of the upper normal limit
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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 EGFR FISH positive advanced NSCLC Stage IIIB or IV.;Secondary Objective: Disease control (CR, PR, SD) as determined by RECIST criteria (R01-0754) Progression-free survival time Overall survival time Pharmacokinetics Presence of K-ras and EGFR mutation Safety of BIBW 2992 as indicated by intensity and incidence of adverse events, graded according to US NCI CTCAE Version 3.0 (R04-0474), especially skin reactions and GI adverse events;Primary end point(s): The primary endpoint will be objective response (CR, PR) as determined by the RECIST criteria. | — |
Countries
Italy
Outcome results
None listed