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

Non-small Cell Lung Cancer (NSCLC) Clinical Trial

Official title:

A Phase I Study of ZD6474 (Vandetanib) Concurrent With Whole Brain Radiotherapy for the Treatment of Brain Metastases in Patients With Non-small Cell Lung Cancer (NSCLC)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00807170
• Other study ID #: D4200C00085
• Secondary ID: EUDRACT Number 2
• Status: Terminated
• Phase: Phase 1
• First received: December 9, 2008
• Last updated: August 26, 2016
• Start date: May 2009
• Est. completion date: August 2010

Study information

• Verified date: August 2016
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Neoplasm Metastasis
• Non-small Cell Lung Cancer (NSCLC)

Intervention

Drug:
• ZD6474 (Vandetanib)
100 mg as a once daily oral dose, 21 days

Radiation:
• Whole Brain Radiotherapy (WBRT)

Drug:
• ZD6474
200 mg as a once daily oral dose, 21 days
• ZD6474
300 mg as a once daily oral dose, 21 days

Locations

Country	Name	City	State
Netherlands	Research site	Amsterdam
Netherlands	Research site	Groningen
Netherlands	Research site	Maastricht

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	To investigate the time to clinical and radiological progression of brain metastases		Until disease progression	No