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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

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

NCT ID

NCT00807170

First Posted

December 9, 2008

Last Updated

August 26, 2016

Sponsor

Sanofi

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

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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