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

Saturday, March 1, 2008

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…

Date First Received: January 9, 2008

Last Updated: April 23, 2008

Verified by: AstraZeneca, April 2008

Clinical Trial Phase: Phase 2 Start Date: December 2007

Overall Status: Recruiting

Estimated Enrollment: 66

Brief Summary 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.”

Condition Keyword(s):

• Mesothelioma

Intervention(s):

• Drug: Vinorelbine
• Drug: Vandetanib

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 Outcome Measures for this Clinical Trial

Primary:

• To evaluate the efficacy of vandetanib compared with vinorelbine by estimating the Overall Disease Control Rate (DCR=CR+PR+SD) Assessed from baseline to week 12

Secondary:

• To estimate the Overall Objective Response Rate (ORR=CR+PR), Progression-Free Survival (PSF) and Overall Survival (OS). time to progression and death
• To further characterise the safety profile of vandetanib. Quality of life over time assessed from baseline to week 12

Criteria for Participation in this Clinical Trial Inclusion Criteria:

• Men or women aged 18 or over
• 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.

Clinical Trials Locations, Contact Details, and Sponsors Lead Sponsor: AstraZeneca

Research Site Heidelberg Germany

Research Site Essen Germany

Research Site Hamburg Germany

Research Site Halle-Dolau Germany

Research Site Zurich Switzerland

Research Site Chur Switzerland

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

Additional Information Information obtained from ClinicalTrials.gov on April 29, 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 Clinical Trials Authorship and Review

Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org.

Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.

Labels: ClinicalTrial

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