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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
119
30 mg \& 45 mg oral tablet
Research Site
Freiburg im Breisgau, Germany
Research Site
Hamburg, Germany
Research Site
Amsterdam, Netherlands
Research Site
Nijmegen, Netherlands
Research Site
Proportion of Patients Requiring Temporary (>1 Day) or Permanent Withdrawal of AZD2171 Prior to Progression and Within 12 Weeks of First Dose of AZD2171
Time frame: 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)
Time frame: 12 week treatment period
Proportion of Patients Requiring Temporary (>1 Day) or Permanent Withdrawal of AZD2171 Prior to Progression and Within 6 Weeks of First Dose of AZD2171
Time frame: First 6 weeks of 12 week treatment period
Objective Response Rate
Number of patients with complete or partial response (CR/PR), based on RECIST
Time frame: 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.
Time frame: Randomisation until end of treatment period
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Utrecht, Netherlands
Research Site
Surrey, United Kingdom