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.
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.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Number of Participants With Disease Control.
Secondary Outcome
Number of Participants With Objective Response.
Condition
Mesothelioma
Intervention
Vinorelbine
Study Arms / Comparison Groups
1
Description: Vinorelbine
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
25
Start Date
December 2007
Completion Date
January 2010
Primary Completion Date
January 2010
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.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Clinical Sciences & Operations, ,
Location Countries
Germany
Location Countries
Germany
Administrative Informations
NCT ID
NCT00597116
Organization ID
D4200C00075
Secondary IDs
EUDRACT Number 2007-003633-16
Responsible Party
Sponsor
Study Sponsor
Genzyme, a Sanofi Company
Study Sponsor
Clinical Sciences & Operations, Study Director, Sanofi
Verification Date
August 2016