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

Phase 1

Terminated

• Conditions: Non-small Cell Lung Cancer (NSCLC)
• Interventions: Drug: ZD6474 (Vandetanib); Radiation: Whole Brain Radiotherapy (WBRT); Drug: ZD6474

• Registration Number: NCT00807170
• Lead Sponsor: Sanofi

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-12-09
• Study First Submitted QC: 2008-12-10
• Study First Posted: 2008-12-11
• Study Start: 2009-05
• Primary Completion: 2010-08
• Study Completion: 2010-08
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-26
• Last Update Posted: 2016-08-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ZACTIMA TM	ZD6474 (Vandetanib)	-
ZACTIMA TM	ZD6474	-
ZACTIMA TM	Whole Brain Radiotherapy (WBRT)	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
To investigate the time to clinical and radiological progression of brain metastases	Until disease progression

Trial Locations

Locations (1)

Research site; 🇳🇱 Maastricht, Netherlands