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

Phase 2

Completed

• Conditions: Tumors
• Interventions: Drug: AZD2171

• Registration Number: NCT00264004
• Lead Sponsor: AstraZeneca

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-11
• Study First Submitted: 2005-12-09
• Study First Submitted QC: 2005-12-09
• Study First Posted: 2005-12-12
• Primary Completion: 2007-01
• Study Completion: 2011-04
• Disposition First Submitted: 2011-04-06
• Disposition First Submitted QC: 2011-04-06
• Disposition First Posted: 2011-04-12
• Status Verified: 2012-07
• Results First Submitted: 2012-07-26
• Results First Submitted QC: 2012-07-26
• Last Update Submitted: 2012-07-26
• Results First Posted: 2012-08-29
• Last Update Posted: 2012-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 119

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
1	AZD2171	30 mg AZD2171
2	AZD2171	45 mg AZD2171

Primary Outcome Measures

Name	Time	Method
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	12 week treatment period	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)

Secondary Outcome Measures

Name	Time	Method
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	12 week treatment period	Number of patients with complete or partial response (CR/PR), based on RECIST
Best Percentage Change in Tumour Size	Randomisation until end of treatment period	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.

Trial Locations

Locations (1)

Research Site; 🇬🇧 Surrey, United Kingdom