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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

Primary Purpose

Non-small Cell Lung Cancer (NSCLC)

Status
Terminated
Phase
Phase 1
Locations
Netherlands
Study Type
Interventional
Intervention
ZD6474 (Vandetanib)
Whole Brain Radiotherapy (WBRT)
ZD6474
ZD6474
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer (NSCLC) focused on measuring Non-small Cell Lung Cancer (NSCLC), Whole Brain Radiotherapy, metastasis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Research site
  • Research site
  • Research site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ZACTIMA TM

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

To investigate the time to clinical and radiological progression of brain metastases

Full Information

First Posted
December 9, 2008
Last Updated
August 26, 2016
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT00807170
Brief Title
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
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)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Terminated
Why Stopped
Very slow recruitment
Study Start Date
May 2009 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
August 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer (NSCLC)
Keywords
Non-small Cell Lung Cancer (NSCLC), Whole Brain Radiotherapy, metastasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ZACTIMA TM
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
ZD6474 (Vandetanib)
Other Intervention Name(s)
ZACTIMA TM
Intervention Description
100 mg as a once daily oral dose, 21 days
Intervention Type
Radiation
Intervention Name(s)
Whole Brain Radiotherapy (WBRT)
Intervention Type
Drug
Intervention Name(s)
ZD6474
Other Intervention Name(s)
ZACTIMA TM
Intervention Description
200 mg as a once daily oral dose, 21 days
Intervention Type
Drug
Intervention Name(s)
ZD6474
Other Intervention Name(s)
ZACTIMA TM
Intervention Description
300 mg as a once daily oral dose, 21 days
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
To investigate the time to clinical and radiological progression of brain metastases
Time Frame
Until disease progression

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Research site
City
Amsterdam
Country
Netherlands
Facility Name
Research site
City
Groningen
Country
Netherlands
Facility Name
Research site
City
Maastricht
Country
Netherlands

12. IPD Sharing Statement

Learn more about this trial

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

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