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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Tumors

Intervention / Treatment
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* Drug: AZD2171


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>30 mg AZD2171 | Drug: AZD2171<br>* 30 mg & 45 mg oral tablet<br>* Other names: RECENTIN™;|
| Experimental: 2<br>45 mg AZD2171 | Drug: AZD2171<br>* 30 mg & 45 mg oral tablet<br>* Other names: RECENTIN™;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Patients Requiring Temporary (>1 Day) or Permanent Withdrawal of AZD2171 Prior to Progression and Within 12 Weeks of First Dose of AZD2171 |  | 12 week treatment period | 
| Proportion of Planned Dose Received During First 12 Weeks of Therapy With AZD2171 | 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) | 12 week treatment period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Patients Requiring Temporary (>1 Day) or Permanent Withdrawal of AZD2171 Prior to Progression and Within 6 Weeks of First Dose of AZD2171 |  | First 6 weeks of 12 week treatment period | 
| Objective Response Rate | Number of patients with complete or partial response (CR/PR), based on RECIST | 12 week treatment period | 
| Best Percentage Change in Tumour Size | 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. | Randomisation until end of treatment period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Advanced Solid Tumours, phase II, Hypertension, RECENTIN