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

Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00264004
• Other study ID #: D8480C00038
• Secondary ID: EUDRACT Number 2
• Status: Completed
• Phase: Phase 2
• First received: December 9, 2005
• Last updated: July 26, 2012
• Start date: November 2005
• Est. completion date: April 2011

Study information

• Verified date: July 2012
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 119
• Est. completion date: April 2011
• Est. primary completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension
• Tumors

Intervention

Drug:
• AZD2171
30 mg & 45 mg oral tablet

Locations

Country	Name	City	State
Germany	Research Site	Freiburg
Germany	Research Site	Hamburg
Netherlands	Research Site	Amsterdam
Netherlands	Research Site	Nijmegen
Netherlands	Research Site	Utrecht
United Kingdom	Research Site	Surrey

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

Germany,  Netherlands,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	Objective Response Rate	Number of patients with complete or partial response (CR/PR), based on RECIST	12 week treatment period	No
Secondary	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	No

External Links

•   AstraZeneca Information - Outside of the US