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

Sanofi

Status and phase: Terminated; Phase 1

Conditions: Non-small Cell Lung Cancer (NSCLC)

Treatments: Radiation: Whole Brain Radiotherapy (WBRT); Drug: ZD6474; Drug: ZD6474 (Vandetanib)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00807170

EUDRACT Number 2008-005556-24

D4200C00085

Details and patient eligibility

About

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.

Enrollment: 5 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

ZACTIMA TM

Experimental group

Treatment:

Radiation: Whole Brain Radiotherapy (WBRT)

Drug: ZD6474

Drug: ZD6474 (Vandetanib)

Drug: ZD6474