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

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ClinicalTrials.gov Identifier: NCT00597116
Recruitment Status : Terminated (Recruitment stopped according to early stopping rule (by protocol))
First Posted : January 17, 2008
Results First Posted : October 15, 2012
Last Update Posted : October 10, 2016
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company )

Tracking Information
First Submitted Date  ICMJE January 9, 2008
First Posted Date  ICMJE January 17, 2008
Results First Submitted Date  ICMJE April 27, 2011
Results First Posted Date  ICMJE October 15, 2012
Last Update Posted Date October 10, 2016
Study Start Date  ICMJE December 2007
Actual Primary Completion Date January 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 14, 2012)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: January 16, 2008)
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 ]
Change History Complete list of historical versions of study NCT00597116 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 14, 2012)
  • 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. ]
Original Secondary Outcome Measures  ICMJE
 (submitted: January 16, 2008)
  • 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 ]
  • To further characterise the safety profile of vandetanib. Quality of life over time [ Time Frame: assessed from baseline to week 12 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An Efficacy and Safety Study With Vandetanib to Treat Inoperable or Relapsed Malignant Mesothelioma
Official Title  ICMJE 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Mesothelioma
Intervention  ICMJE
  • Drug: Vinorelbine
    Other Name: Navelbine®
  • Drug: Vandetanib
    once daily oral dose
    Other Names:
    • ZD6474
    • ZACTIMA™
Study Arms  ICMJE
  • Active Comparator: 1
    Vinorelbine
    Intervention: Drug: Vinorelbine
  • Experimental: 2
    Vandetanib
    Intervention: Drug: Vandetanib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: September 14, 2012)
25
Original Estimated Enrollment  ICMJE
 (submitted: January 16, 2008)
66
Actual Study Completion Date  ICMJE January 2010
Actual Primary Completion Date January 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany,   Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00597116
Other Study ID Numbers  ICMJE D4200C00075
EUDRACT Number 2007-003633-16
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sanofi ( Genzyme, a Sanofi Company )
Study Sponsor  ICMJE Genzyme, a Sanofi Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Sciences & Operations Sanofi
PRS Account Sanofi
Verification Date August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP