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

This study has been terminated.
(Recruitment stopped according to early stopping rule (by protocol))
Sponsor:
ClinicalTrials.gov Identifier:
NCT00597116
First Posted: January 17, 2008
Last Update Posted: October 10, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company )
  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.

Condition Intervention Phase
Mesothelioma Drug: Vinorelbine Drug: Vandetanib Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Sanofi ( Genzyme, a Sanofi Company ):

Primary Outcome Measures:
  • Number of Participants With Disease Control. [ Time Frame: Assessed at 2 months. ]
    Disease control is defined as having a complete response (CR), a partial response (PR) or stable disease (SD) according to the modified RECIST criteria for assessment of response in malignant pleural mesothelioma. CR is defined as the disappearance of all target lesions with no evidence of tumour elsewhere and PR is defined as at least a 30% reduction in the total tumour measurement. A confirmed response requires a repeat observation on two occasions 4 weeks apart. PD is defined as an increase of at least 20% in the total tumour measurement over the nadir measurement, or the appearance of one or more new lesions. Patients with SD are those who fulfill the criteria for neither PR nor PD.


Secondary Outcome Measures:
  • Number of Participants With Objective Response. [ Time Frame: Assessed at 2 months. ]
    Objective response is defined as having a complete response (CR) or a partial response (PR) according to the modified RECIST criteria for assessment of response in malignant pleural mesothelioma. CR is defined as the disappearance of all target lesions with no evidence of tumour elsewhere and PR is defined as at least a 30% reduction in the total tumour measurement. A confirmed response requires a repeat observation on two occasions 4 weeks apart.

  • Progression-free Survival (PFS) [ Time Frame: Assessed from baseline to 12 months. ]
    Time from randomization to date of documented response of progressive disease (PD) as assessed according to the modified RECIST criteria for assessment of response in malignant pleural mesothelioma. PD is defined as an increase of at least 20% in the total tumour measurement over the nadir measurement, or the appearance of one or more new lesions.

  • Overall Survival (OS) [ Time Frame: Assessed from baseline to 12 months. ]

Enrollment: 25
Study Start Date: December 2007
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Vinorelbine
Drug: Vinorelbine
Other Name: Navelbine®
Experimental: 2
Vandetanib
Drug: Vandetanib
once daily oral dose
Other Names:
  • ZD6474
  • ZACTIMA™

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00597116


Locations
Germany
Research Site
Essen, Germany
Research Site
Halle-Dolau, Germany
Research Site
Hamburg, Germany
Research Site
Heidelberg, Germany
Switzerland
Research Site
Chur, Switzerland
Research Site
Zurich, Switzerland
Sponsors and Collaborators
Genzyme, a Sanofi Company
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

Responsible Party: Genzyme, a Sanofi Company
ClinicalTrials.gov Identifier: NCT00597116     History of Changes
Other Study ID Numbers: D4200C00075
EUDRACT Number 2007-003633-16
First Submitted: January 9, 2008
First Posted: January 17, 2008
Results First Submitted: April 27, 2011
Results First Posted: October 15, 2012
Last Update Posted: October 10, 2016
Last Verified: August 2016

Keywords provided by Sanofi ( Genzyme, a Sanofi Company ):
Mesothelioma
inoperable
relapsed

Additional relevant MeSH terms:
Mesothelioma
Lung Neoplasms
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Mesothelial
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Vinorelbine
Vinblastine
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action