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

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Tumors

Treatments: Drug: AZD2171

Study type: Interventional

Funder types: Industry

Identifiers

NCT00264004

EUDRACT Number 2005-003442-33

D8480C00038

Details and patient eligibility

About

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.

Enrollment: 119 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Quadruple Blind

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119 participants in 2 patient groups

1

Experimental group

Description:

30 mg AZD2171

Treatment:

Drug: AZD2171

2

Experimental group

Description:

45 mg AZD2171

Treatment:

Drug: AZD2171