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

NCT00807170 | Terminated Phase 1 DMC

• 2 other identifiers: D4200C00085EUDRACT Number 2008-005556-24
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 3

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.

Conditions

Non-small Cell Lung Cancer (NSCLC)

Keywords

Non-small Cell Lung Cancer (NSCLC); Whole Brain Radiotherapy; metastasis

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

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

  Until disease progression

Study Arms (1)

ZACTIMA TM

EXPERIMENTAL

Drug: ZD6474 (Vandetanib); Radiation: Whole Brain Radiotherapy (WBRT); Drug: ZD6474

Interventions

ZD6474 (Vandetanib) DRUG

100 mg as a once daily oral dose, 21 days

Also known as: ZACTIMA TM

ZACTIMA TM

Whole Brain Radiotherapy (WBRT) RADIATION

ZACTIMA TM

ZD6474 DRUG

200 mg as a once daily oral dose, 21 days

Also known as: ZACTIMA TM

ZACTIMA TM

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sanofi: lead

Study Sites (3)

Research site

Amsterdam, Netherlands

Location

Research site

Groningen, Netherlands

Location

Research site

Maastricht, Netherlands

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Neoplasm Metastasis

Interventions

vandetanib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2008
• First Posted: December 11, 2008
• Study Start: May 1, 2009
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: August 29, 2016

Record last verified: 2016-08

Locations

NL (3)