Non-small Cell Lung Cancer (NSCLC)
Conditions
Keywords
Non-small Cell Lung Cancer (NSCLC), Whole Brain Radiotherapy, metastasis
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 will start 7 days prior to start of radiation treatment with Vandetanib. Total treatment time with Vandetanib is 3 weeks (21 days). Patients will have the opportunity to continue Vandetanib until progression at a dose of 300 mg. This multi-centre study will be conducted in a minimum of 9 patients and a maximum of 18 patients at 3 sites.
Interventions
100 mg as a once daily oral dose, 21 days
RADIATIONWhole Brain Radiotherapy (WBRT)
DRUGZD6474
200 mg as a once daily oral dose, 21 days
Sponsors
Sanofi
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To investigate the maximum tolerated dose of Vandetanib and concurrent WBRT in patients with NSCLC and brain metastases | All evaluable patients (all registered patients who receive at least opne dose of study medication) who have completed week 9 study period |
Secondary
| Measure | Time frame |
|---|---|
| To investigate the time to clinical and radiological progression of brain metastases | Until disease progression |
Countries
Netherlands
Outcome results
None listed