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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

This study has been terminated.
(Very slow recruitment)
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00807170
First received: December 9, 2008
Last updated: August 26, 2016
Last verified: August 2016
  Purpose
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.

Condition Intervention Phase
Non-small Cell Lung Cancer (NSCLC)
Drug: ZD6474 (Vandetanib)
Radiation: Whole Brain Radiotherapy (WBRT)
Drug: ZD6474
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • To investigate the maximum tolerated dose of Vandetanib and concurrent WBRT in patients with NSCLC and brain metastases [ Time Frame: 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:
  • To investigate the time to clinical and radiological progression of brain metastases [ Time Frame: Until disease progression ]

Enrollment: 5
Study Start Date: May 2009
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ZACTIMA TM Drug: ZD6474 (Vandetanib)
100 mg as a once daily oral dose, 21 days
Other Name: ZACTIMA TM
Radiation: Whole Brain Radiotherapy (WBRT) Drug: ZD6474
200 mg as a once daily oral dose, 21 days
Other Name: ZACTIMA TM
Drug: ZD6474
300 mg as a once daily oral dose, 21 days
Other Name: ZACTIMA TM

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00807170

Locations
Netherlands
Research site
Amsterdam, Netherlands
Research site
Groningen, Netherlands
Research site
Maastricht, Netherlands
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00807170     History of Changes
Other Study ID Numbers: D4200C00085  EUDRACT Number 2008-005556-24 
Study First Received: December 9, 2008
Last Updated: August 26, 2016

Keywords provided by Sanofi:
Non-small Cell Lung Cancer (NSCLC)
Whole Brain Radiotherapy
metastasis

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Neoplasm Metastasis
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Neoplastic Processes
Pathologic Processes

ClinicalTrials.gov processed this record on February 24, 2017