Heart and Blood Diseases

All Conditions

Hypertension

Vascular Diseases

Antineoplastic Agents

All Drugs and Chemicals

Cediranib

Protein Kinase Inhibitors

Enzyme Inhibitors

AZD2171

Jane Robertson, MD

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

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

Total actual dose received during the first 12 weeks prior to progression divided by the planned dose (planned dose: initial allocated dose multiplied by the number of days on study during the first 12 weeks prior to progression)

Number of patients with complete or partial response (CR/PR), based on RECIST

Maximum percentage reduction or minimum percentage increase in tumour size where size is the sum of the longest diameters of the target lesions. Based on the baseline scaled ratio: ratio of the post-randomisation visit tumour size divided by the baseline tumour size.

AstraZeneca

AZD2171 30 mg Anti HT

AZD2171 30 mg No Anti HT

AZD2171 45 mg Anti HT

AZD2171 45 mg No Anti HT

Total

Age Continuous

Sex: Female, Male

Gerard Lynch

Proportion of Patients Requiring Temporary (>1 Day) or Permanent Withdrawal of AZD2171 Prior to Progression and Within 12 Weeks of First Dose of AZD2171

Proportion of Planned Dose Received During First 12 Weeks of Therapy With AZD2171

Proportion of Patients Requiring Temporary (>1 Day) or Permanent Withdrawal of AZD2171 Prior to Progression and Within 6 Weeks of First Dose of AZD2171

Objective Response Rate

Best Percentage Change in Tumour Size

Overall Study

Spots Global Cancer Trial Database for Study to Investigate the Management of Hypertension and Efficacy of AZD2171 in Patients With Advanced Solid Tumours

Trial Identification

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Interventions

Study Description

Keywords

Eligibility

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