Fase II studie van sorafenib bij patienten met een gemetastaseerd niet-kleincellig bronchuscarcinoom die progressief zijn na voorafgaande behandeling met cisplatina bevattende chemotherapie waarvan de tumor een K-Ras mutatie bevat.
Recruiting
- Conditions
- on-Small Cell Lung Cancer
- Registration Number
- NL-OMON25401
- Lead Sponsor
- Vrije Universiteit Medisch centrumPostbus 70571007 MB AmsterdamNetherlands
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 46
Inclusion Criteria
1. Histologically advanced NSCLC stage IIIB or IV harbouring a K-RAS mutation;
2. Disease progression after at least 1 prior chemotherapy regimen that should include a platinum doublet;
Exclusion Criteria
Excluded medical conditions:
1. History of cardiac disease: congestive heart failure >NYHA class 2; active CAD (MI more than 6 mo prior to study entry is allowed); cardiac arythmias requiring anti-arythmic therapy (beta blockers or digoxin are permitted) or uncontrolled hypertension;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Rate of non-progression at 6 weeks according to the RECISCT criteria.
- Secondary Outcome Measures
Name Time Method Efficacy of sorafenib as determined by:<br /><br>1. Duration of response;<br /><br>2. Time to disease progression or death;<br /><br>3. Survival.