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

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

MedlinePlus related topics:

Mesothelioma

Drug Information available for:

Vinorelbine Vinorelbine tartrate Vandetanib

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

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.

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:	December 2009
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Vinorelbine	Drug: Vinorelbine
2: Experimental Vandetanib	Drug: Vandetanib once daily oral dose

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

Contacts


Contact: AstraZeneca Switzerland Clinical Study Information	+0041 41 725 76 14

Locations


Germany
	Research Site	Recruiting
	Heidelberg, Germany
	Research Site	Recruiting
	Essen, Germany
	Research Site	Recruiting
	Hamburg, Germany
	Research Site	Recruiting
	Halle-Dolau, Germany

Switzerland
	Research Site	Recruiting
	Zurich, Switzerland
	Research Site	Recruiting
	Chur, 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

Responsible Party:	AstraZeneca ( Peter Langmuir - Medical Science Director )
Study ID Numbers:	D4200C00075, EUDRACT Number 2007-003633-16
First Received:	January 9, 2008
Last Updated:	April 30, 2008
ClinicalTrials.gov Identifier:	NCT00597116
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices; Switzerland: Swissmedic

Keywords provided by AstraZeneca:

Mesothelioma

inoperable

relapsed

Study placed in the following topic categories:

Vinorelbine

Mesothelioma

Adenoma

Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Histologic Type

Antineoplastic Agents

Neoplasms, Mesothelial

Therapeutic Uses

Antineoplastic Agents, Phytogenic

Pharmacologic Actions

ClinicalTrials.gov processed this record on November 20, 2008

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