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

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

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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Factorial Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer High Blood Pressure

Drug Information available for: Cediranib

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Proportion of patients requiring temporary (>1 day) or permanent withdrawal of AZD2171 prior to progression and within 12 weeks of first dose of AZD2171 [ Time Frame: Assessed at each visit for 12 weeks ] [ Designated as safety issue: No ]
Proportion of planned dose received during first 12 weeks of therapy with AZD2171 [ Time Frame: range of 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Proportion of patients requiring temporary (>1 day) or permanent withdrawal of AZD2171 prior to progression and within 6 weeks of first dose of AZD2171 [ Time Frame: Assessed at each visit for 12 weeks ] [ Designated as safety issue: No ]
Objective response rate [ Time Frame: Range of 12 weeks ] [ Designated as safety issue: No ]
Best percentage change in tumour size [ Time Frame: Range of 12 weeks ] [ Designated as safety issue: No ]

Enrollment:	119
Study Start Date:	November 2005
Study Completion Date:	April 2011
Primary Completion Date:	January 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 30 mg AZD2171	Drug: AZD2171 30 mg & 45 mg oral tablet Other Names: cediranib RECENTIN™
Experimental: 2 45 mg AZD2171	Drug: AZD2171 30 mg & 45 mg oral tablet Other Names: cediranib RECENTIN™

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:

Jane Robertson, MD

AstraZeneca

More Information

No publications provided

Responsible Party:	MSD, AstraZeneca
ClinicalTrials.gov Identifier:	NCT00264004 History of Changes
Other Study ID Numbers:	D8480C00038, EUDRACT Number 2005-003442-33
Study First Received:	December 9, 2005
Last Updated:	August 24, 2011
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by AstraZeneca:

Advanced Solid Tumours
phase II
Hypertension
RECENTIN

Additional relevant MeSH terms:

Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on February 09, 2012