Know Cancer

or
forgot password

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)


Phase 1
18 Years
N/A
Not Enrolling
Both
Non-small Cell Lung Cancer

Thank you

Trial Information

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)


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

To investigate the maximum tolerated dose of Vandetanib and concurrent WBRT in patients with NSCLC and brain metastases

Outcome Time Frame:

All evaluable patients (all registered patients who receive at least opne dose of study medication) who have completed week 9 study period

Safety Issue:

No

Principal Investigator

A. C. Dingemans, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Medical Centre Maastricht, the Netherlands

Authority:

Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Study ID:

D4200C00085

NCT ID:

NCT00807170

Start Date:

May 2009

Completion Date:

August 2010

Related Keywords:

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

Name

Location