Official Title: “A Randomized Phase II Trial To Evaluate The Efficacy And Safety Of Vandetanib (ZD6474, ZACTIMA ™) Versus Vinorelbine In Patients With Inoperable Or Relapsed Malignant Mesothelioma.”

A clinical study to assess if a new investigational drug is effective in treating malignant mesothelioma, compared to a chemotherapy treatment (Navelbine®). In this study the patients will be assigned by chance to receive either the new drug or a chemotherapy treatment (Navelbine®). Treatment will continue as long as the cancer does not worsen and the patient wishes to continue in the study. The study will recruit approximately 66 patients.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: September 2009

Intervention(s) in this Clinical Trial

• Drug: Vinorelbine
• Drug: Vandetanib
  • once daily oral dose

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • Vinorelbine
• Experimental: 2
  • Vandetanib

Primary Measures

• To evaluate the efficacy of vandetanib compared with vinorelbine by estimating the Overall Disease Control Rate (DCR=CR+PR+SD)
  • Time Frame: Assessed from baseline to week 12
    Safety Issue?: No

Secondary Measures

• To estimate the Overall Objective Response Rate (ORR=CR+PR), Progression-Free Survival (PSF) and Overall Survival (OS).
  • Time Frame: time to progression and death
    Safety Issue?: No
• To further characterise the safety profile of vandetanib. Quality of life over time
  • Time Frame: assessed from baseline to week 12
    Safety Issue?: No

Inclusion Criteria:

• Diagnosed with mesothelioma
• Previously treated with only one course of chemotherapy for mesothelioma
• No previous treatment with vinorelbine
• No serious heart problems within the last 3 months

Exclusion Criteria:

• Serious abnormal laboratory values
• Severe or uncontrolled disease or condition as judged by the Investigator
• Pregnant or breast-feeding women
• Other cancers within the last 5 years
• Major surgery or radiation therapy within 4 weeks prior to starting study therapy
• Receipt of any investigational agents within 30 days prior to commencing study treatment.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: AstraZeneca

Overall Clinical Trial Officials and Contacts

Rolf Stahel Principal Investigator University of Zurich  

Overall Contact: AstraZeneca Switzerland Clinical Study Information +0041 41 725 76 14 

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00597116

Study ID Number: D4200C00075

ClinicalTrials.gov Identifier: NCT00597116

Health Authority: Germany: Federal Institute for Drugs and Medical Devices