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

Tracking Information

First Received Date ^ICMJE

January 9, 2008

Last Updated Date

October 23, 2009

Start Date ^ICMJE

December 2007

Estimated Primary Completion Date

January 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00597116 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

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

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Mesothelioma

Intervention ^ICMJE

Drug: Vinorelbine
Drug: Vandetanib

Study Arms / Comparison Groups

Active Comparator: Vinorelbine
Experimental: Vandetanib

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 ^ICMJE

Terminated

Estimated Enrollment ^ICMJE

Estimated Completion Date

January 2010

Estimated 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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany, Switzerland

Administrative Information

NCT ID ^ICMJE

NCT00597116

Responsible Party

Peter Langmuir - Medical Science Director, AstraZeneca

Study ID Numbers ^ICMJE

D4200C00075, EUDRACT Number 2007-003633-16

Study Sponsor ^ICMJE

AstraZeneca

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:	Rolf Stahel	University of Zurich
Study Director:	Madeleine Billeter	AstraZeneca
Study Chair:	Verena Renggli, MSc	AstraZeneca

Information Provided By

AstraZeneca

Verification Date

October 2009

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