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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:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00597116
First received: January 9, 2008
Last updated: September 14, 2012
Last verified: September 2012
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

MedlinePlus related topics: Mesothelioma
U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Number of Participants With Disease Control. [ Time Frame: Assessed at 2 months. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
AstraZeneca
Investigators
Principal Investigator: Rolf Stahel University of Zurich
Study Director: Dirk Schneider AstraZeneca
Study Chair: Erica Pellicioli, PhD AstraZeneca
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00597116     History of Changes
Other Study ID Numbers: D4200C00075, EUDRACT Number 2007-003633-16
Study First Received: January 9, 2008
Results First Received: April 27, 2011
Last Updated: September 14, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Switzerland: Swissmedic

Keywords provided by AstraZeneca:
Mesothelioma
inoperable
relapsed

Additional relevant MeSH terms:
Mesothelioma
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Mesothelial
 Vinorelbine
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013