An Efficacy and Safety Study With Vandetanib to Treat Inoperable or Relapsed Malignant Mesothelioma

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.

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 Investigator: AstraZeneca Industry

Overall Clinical Trial Officials and Contacts

Rolf Stahel Principal Investigator University of Zurich  

Information obtained from ClinicalTrials.gov on February 12, 2012

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