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.

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, 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 Outcomes: 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 in the first 12 weeks of treatment.

Secondary Outcomes: 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, during the first 12 weeks of therapy

Expected Total Enrollment:  120

Study start: November 2005

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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:

Exclusion Criteria:

• Prior treatment with a VEGF inhibitor
• Poorly controlled hypertension

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier NCT00264004

AstraZeneca Clinical Study Information http://www.astrazeneca.com/node/emailtriage.aspx

United Kingdom
Research Site, Sutton, United Kingdom; Recruiting

Study chairs or principal investigators

AstraZeneca AZD2171 Medical Science Director, MD, Study Director, AstraZeneca

More Information

Study ID Numbers: D8480C00038; EUDRACT Number 2005-003442-33
Last Updated: January 31, 2006
Record first received: December 9, 2005
ClinicalTrials.gov Identifier: NCT00264004
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
ClinicalTrials.gov processed this record on 2006-07-24