|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
19 October 2017 |
|
Main ID: |
NCT00264004 |
|
Date of registration:
|
09/12/2005 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Study to Investigate the Management of Hypertension and Efficacy of AZD2171 in Patients With Advanced Solid Tumours
|
|
Scientific 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 |
|
Date of first enrolment:
|
November 2005 |
|
Target sample size:
|
119 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT00264004 |
|
Study type:
|
Interventional |
|
Study design:
|
|
|
Phase:
|
Phase 2
|
|
|
Countries of recruitment
|
|
Germany
|
Netherlands
|
United Kingdom
| | | | | |
|
Contacts
|
|
Name:
|
Jane Robertson, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
AstraZeneca |
| | |
|
Key inclusion & exclusion criteria
|
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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Tumors
|
|
Intervention(s)
|
|
Drug: AZD2171
|
|
Primary Outcome(s)
|
|
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
[Time Frame: 12 week treatment period]
|
|
Secondary Outcome(s)
|
|
Best Percentage Change in Tumour Size
[Time Frame: Randomisation until end of treatment period]
|
|
Objective Response Rate
[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]
|
|
Secondary ID(s)
|
|
D8480C00038
|
|
EUDRACT Number 2005-003442-33
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|