Study to Investigate the Management of Hypertension and Efficacy of AZD2171 in Patients With Advanced Solid Tumours - Full Text View

Purpose

The purpose of this study is to determine whether doses of 30 mg and 45 mg AZD2171 can be well tolerated without significant drug withdrawal when accompanied by a suitable hypertension management strategy or dose reduction.

Condition	Intervention	Phase
Tumors	Drug: AZD2171	Phase II

MedlinePlus related topics:

Cancer High Blood Pressure

ChemIDplus related topics:

Cediranib

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Factorial Assignment, Safety/Efficacy Study

Official Title:	A Phase II, Randomised, Factorial, Double-Blind Study to Investigate the Management of AZD2171-Induced Hypertension and Efficacy of AZD2171 at Doses of 30 mg and 45 mg in Patients With Advanced Solid Tumours

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

The primary objective of the study is to identify an optimal treatment strategy for AZD2171, consisting of a dose of AZD2171 and a hypertension management strategy that maximises patient drug exposure [ Time Frame: Assessed at each visit for 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To estimate the activity of AZD2171 monotherapy using objective response rate (consisting of complete response and partial response) and stable disease rate based on RECIST [ Time Frame: Assessed at each visit for 12 weeks ] [ Designated as safety issue: No ]

Enrollment:	119
Study Start Date:	November 2005
Estimated Study Completion Date:	May 2008

Arms	Assigned Interventions
1: Experimental 30 mg AZD2171	Drug: AZD2171 30 mg & 45 mg oral tablet
2: Experimental 45 mg AZD2171	Drug: AZD2171 30 mg & 45 mg oral tablet

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Histological or cytological confirmation of advanced solid tumour, which is refractory to standard therapies or for which no standard therapy exists and for which there is a rationale for the therapeutic use of a vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor.

Exclusion Criteria:

Prior treatment with a VEGF inhibitor
Poorly controlled hypertension

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00264004

Locations


Germany
	Research Site
	FREIBURG, Germany
	Research Site
	HAMBURG, Germany

Netherlands
	Research Site
	AMSTERDAM, Netherlands
	Research Site
	NIJMEGEN, Netherlands
	Research Site
	UTRECHT, Netherlands

United Kingdom
	Research Site
	Surrey, United Kingdom

Sponsors and Collaborators

AstraZeneca

Investigators


Study Director:	AstraZeneca AZD2171 Medical Science Director, MD	AstraZeneca

More Information

AstraZeneca Information - Outside of the US This link exits the ClinicalTrials.gov site

Study ID Numbers:	D8480C00038, EUDRACT Number 2005-003442-33
First Received:	December 9, 2005
Last Updated:	December 15, 2007
ClinicalTrials.gov Identifier:	NCT00264004
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by AstraZeneca:

Advanced Solid Tumours

phase II

Hypertension

RECENTIN

Study placed in the following topic categories:

Vascular Diseases

Hypertension

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 10, 2008

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00264004