Status:
TERMINATED
Investigate the Maximum Tolerated Dose of Vandetanib and Concurrent Whole Brain Radiotherapy (WBRT) in Patients With Non-small Cell Lung Cancer (NSCLC) and Brain Metastases
Lead Sponsor:
Sanofi
Conditions:
Non-small Cell Lung Cancer (NSCLC)
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
A clinical study to investigate the maximum tolerated dose of Vandetanib and concurrent WBRT in patients with NSCLC and brain metastases. All patients will receive WBRT, 10 fractions of 3 Gy. Patients...
Eligibility Criteria
Inclusion
- Male and female patients aged above 18 years with histologically or cytologically confirmed NSCLC and contrast-enhanced CT scan or Gadolinium-enhanced MRI confirmed brain metastases who have a performance status of 0 to 2
- No previous radiotherapy, surgery or chemotherapy for brain metastases
- Patients should not have any unstable systemic disease
Exclusion
- Serious abnormal laboratory values
- Evidence of severe or uncontrolled systemic disease or any concurrent condition which in the Investigator's opinion makes it undesirable for the patient to participate in the trial or which would jeopardize compliance with the protocol
- Clinically significant cardiovascular event (e.g. myocardial infarction, superior vena cava syndrome (SVC), New York Heart Association (NYHA) classification of heart disease \>2 within 3 months before entry; or presence of cardiac disease that, in the
- Previous randomization of treatment in the present study and/ or current participation in another clinical study
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT00807170
Start Date
May 1 2009
End Date
August 1 2010
Last Update
August 29 2016
Active Locations (3)
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1
Research site
Amsterdam, Netherlands
2
Research site
Groningen, Netherlands
3
Research site
Maastricht, Netherlands