Mesothelioma Related Clinical Trials:
A Randomized Phase II Trial To Evaluate The Efficacy And Safety Of Vandetanib (ZD6474, ZACTIMA â„¢) Versus Vinorelbine In Patients With Inoperable Or Relapsed Malignant Mesothelioma.


    - General Info     - Purpose     - Eligibility     - Contacts & Locations     - Additional Information

Status: Recruiting
Sponsors and Collaborators: AstraZeneca
Information provided by: AstraZeneca
Government Identifier: NCT00597116

Condition: Mesothelioma
Intervention: Drug: Vinorelbine; Drug: Vandetanib

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Purpose:


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
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.

Further study details as provided by AstraZeneca:

Primary Outcome 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 ] [ Designated as safety issue: No ]

Secondary Outcome 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 ] [ Designated as safety issue: No ]
  • To further characterise the safety profile of vandetanib. Quality of life over time [ Time Frame: assessed from baseline to week 12 ] [ Designated as safety issue: No ]

Estimated Enrollment:   66
Study Start Date:   December 2007
Estimated Study Completion Date:   December 2009

Arms Assigned Interventions
1: Active Comparator
Vinorelbine
Drug: Vinorelbine
2: Experimental
Vandetanib
Drug: Vandetanib
once daily oral dose

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Eligibility:

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

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.

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Contacts and Locations:

Please refer to this study by its ClinicalTrials.gov identifier: NCT00597116

Contacts
Contact: AstraZeneca Switzerland Clinical Study Information     +0041 41 725 76 14    
Locations
Germany
Research Site     Not yet recruiting
      Heidelberg, Germany
Research Site     Not yet recruiting
      Essen, Germany
Research Site     Not yet recruiting
      Hamburg, Germany
Research Site     Not yet recruiting
      Halle-Dolau, Germany
Switzerland
Research Site     Not yet recruiting
      Zurich, Switzerland
Research Site     Recruiting
      Chur, Switzerland

Sponsors and Collaborators
AstraZeneca

Investigators
Principal Investigator:     Rolf Stahel     University of Zurich    
Study Director:     Madeleine Billeter     AstraZeneca    
Study Chair:     Verena Renggli, MSc     AstraZeneca    

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Additional Information:

Study ID Numbers:   D4200C00075, EUDRACT Number 2007-003633-16
First Received:   January 9, 2008
Last Updated:   January 16, 2008
ClinicalTrials.gov Identifier:   NCT00597116
Health Authority:   Germany: Federal Institute for Drugs and Medical Devices;   Switzerland: Swissmedic

Keywords provided by AstraZeneca:
Mesothelioma  
inoperable  
relapsed  

Study placed in the following topic categories:
Vinorelbine
Mesothelioma
Adenoma
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Mesothelioma
Antineoplastic Agents
Neoplasms, Mesothelial
Therapeutic Uses
Antineoplastic Agents, Phytogenic
Pharmacologic Actions

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