EUCTR2009-017063-42-RO
Active, not recruiting
Phase 1
Biomarkers Impact On the response to Treatment with Erlotinib in first line non-small cell lung Cancer with EGFR activating mutations - BIOTEC
Roche Romania SR0 sitesDecember 6, 2016
Conditionson-small cell lung cancer
DrugsTarceva
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- on-small cell lung cancer
- Sponsor
- Roche Romania SR
- Status
- Active, not recruiting
- Last Updated
- 9 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Written informed consent (informed consent document to be approved by the National Ethics Committee and consent obtained prior to any study\-specific procedure) for biomarkers testing and drug administration
- •2\.Able to comply with the protocol
- •3\.Age \= 18 years
- •4\.Histological documented adenocarcinoma, locally advanced \- stage IIIb, metastatic \- stage IV or recurrent non\-squamous NSCLC.
- •5\.Eastern Cooperative Oncology Group PS status 0\-1
- •6\.Life expectancy \= 12 weeks
- •7\.Patients must have evidence of disease with at least one measurable disease evaluate on RECIST criteria
- •8\.Adequate haematological function:
- •a.Absolute neutrophil count (ANC) \=1\.5 x 109/L AND
- •b.Platelet count \=100 x 109/L AND
Exclusion Criteria
- •1\.Inability or unwillingness to provide informed consent
- •2\.Squamous non\-small cell or small cell tumors or absence of histological report
- •3\.Neoadjuvant/adjuvant chemotherapy within 6 months prior to enrolment
- •4\.Prior exposure to agents directed at the HER axis (e.g. gefitinib, cetuximab, trastuzumab).
- •5\.Prior chemotherapy or treatment with another systemic anti\-cancer agent (for example monoclonal antibody, tyrosine kinase inhibitor) for the treatment of the patient’s current stage of disease (stage IIIB with pleural or pericardial effusion, stage IV or recurrent disease). NOTE: prior surgery and irradiation is permitted provided that the criteria outlined in the protocol for both treatments are met.
- •6\.Radical radiotherapy with curative intent within 28 days prior to enrolment. Palliative radiotherapy for relief of bone pain not involving the thoracic region is allowed prior to enrolment.
- •7\.Treatment with any other investigational agent, or participation in another clinical trial within 28 days prior to enrolment
- •8\.Any active, non\-controlled systemic disease (including infection, grade 4 hypertension, unstable angina, congestive heart failure, hepatic, renal or metabolic disease).
- •9\.Clinically significant (i.e. active) cardiovascular disease for example CVA (\=6 months before enrolment), myocardial infarction (\=6 months before enrolment), unstable angina, congestive heart failure NYHA Class \=II, serious cardiac arrhythmia requiring medication during the study and might interfere with regularity of the study treatment, or not controlled by medication
- •10\.Evidence of ongoing or active infection, any other disease, neurological or metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or puts the patient at high risk for treatment\-related complications
Outcomes
Primary Outcomes
Not specified
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