Back to resultsAn Efficacy and Safety Study With Vandetanib to Treat Inoperable or Relapsed Malignant Mesothelioma
Primary Purpose
Mesothelioma
Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Vinorelbine
Vandetanib
Sponsored by
About this trial
This is an interventional treatment trial for Mesothelioma focused on measuring Mesothelioma, inoperable, relapsed
Eligibility 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.
Sites / Locations
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
1
2
Arm Description
Vinorelbine
Vandetanib
Outcomes
Primary Outcome Measures
Number of Participants With Disease Control.
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.
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 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)
Full Information
NCT ID
NCT00597116
First Posted
January 9, 2008
Last Updated
August 29, 2016
Sponsor
Genzyme, a Sanofi Company
1. Study Identification
Unique Protocol Identification Number
NCT00597116
Brief Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Terminated
Why Stopped
Recruitment stopped according to early stopping rule (by protocol)
Study Start Date
December 2007 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
January 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genzyme, a Sanofi Company
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mesothelioma
Keywords
Mesothelioma, inoperable, relapsed
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Vinorelbine
Arm Title
2
Arm Type
Experimental
Arm Description
Vandetanib
Intervention Type
Drug
Intervention Name(s)
Vinorelbine
Other Intervention Name(s)
Navelbine®
Intervention Type
Drug
Intervention Name(s)
Vandetanib
Other Intervention Name(s)
ZD6474, ZACTIMA™
Intervention Description
once daily oral dose
Primary Outcome Measure Information:
Title
Number of Participants With Disease Control.
Description
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.
Time Frame
Assessed at 2 months.
Secondary Outcome Measure Information:
Title
Number of Participants With Objective Response.
Description
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.
Time Frame
Assessed at 2 months.
Title
Progression-free Survival (PFS)
Description
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.
Time Frame
Assessed from baseline to 12 months.
Title
Overall Survival (OS)
Time Frame
Assessed from baseline to 12 months.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Essen
Country
Germany
Facility Name
Research Site
City
Halle-Dolau
Country
Germany
Facility Name
Research Site
City
Hamburg
Country
Germany
Facility Name
Research Site
City
Heidelberg
Country
Germany
Facility Name
Research Site
City
Chur
Country
Switzerland
Facility Name
Research Site
City
Zurich
Country
Switzerland
12. IPD Sharing Statement
Learn more about this trial
An Efficacy and Safety Study With Vandetanib to Treat Inoperable or Relapsed Malignant Mesothelioma
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