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
18 Years
N/A
Both
Tumors
Trial Information
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
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
Proportion of Patients Requiring Temporary (>1 Day) or Permanent Withdrawal of AZD2171 Prior to Progression and Within 12 Weeks of First Dose of AZD2171
Outcome Time Frame:
12 week treatment period
Safety Issue:
No
Principal Investigator
Jane Robertson, MD
Investigator Role:
Study Director
Investigator Affiliation:
AstraZeneca
Authority:
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Study ID:
D8480C00038
NCT ID:
NCT00264004
Start Date:
November 2005
Completion Date:
April 2011
Related Keywords:
- Tumors
- Advanced Solid Tumours
- phase II
- Hypertension
- RECENTIN
- Hypertension
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