An Efficacy and Safety Study With Vandetanib to Treat Inoperable or Relapsed Malignant Mesothelioma - Full Text View

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00597116

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 II

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

Drug Information available for: Vinorelbine Vinorelbine tartrate Vandetanib

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]
To further characterise the safety profile of vandetanib. Quality of life over time [ Time Frame: assessed from baseline to week 12 ] [ Designated as safety issue: No ]

Estimated Enrollment:	66
Study Start Date:	December 2007
Estimated Study Completion Date:	January 2010
Estimated 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:	Madeleine Billeter	AstraZeneca
Study Chair:	Verena Renggli, MSc	AstraZeneca

More Information

No publications provided

Responsible Party:	Peter Langmuir - Medical Science Director, AstraZeneca
ClinicalTrials.gov Identifier:	NCT00597116 History of Changes
Other Study ID Numbers:	D4200C00075, EUDRACT Number 2007-003633-16
Study First Received:	January 9, 2008
Last Updated:	October 23, 2009
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 February 09, 2012