|
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:
|
EUCTR |
|
Last refreshed on:
|
19 March 2012 |
|
Main ID: |
EUCTR2004-002943-28-EE |
|
Date of registration:
|
01/12/2004 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
A randomised, open -label, parallel-group, international, multicenter phase III study of oral ZD1839 (IRESSA) versus intravenous docetaxel (Taxotere) in patients with locally advanced or metastatic recurrent non small cell lung cancer who have previously received platinum based chemotherapy - INTEREST
|
|
Scientific title:
|
A randomised, open -label, parallel-group, international, multicenter phase III study of oral ZD1839 (IRESSA) versus intravenous docetaxel (Taxotere) in patients with locally advanced or metastatic recurrent non small cell lung cancer who have previously received platinum based chemotherapy - INTEREST |
|
Date of first enrolment:
|
15/11/2004 |
|
Target sample size:
|
1440 |
|
Recruitment status: |
Not Recruiting |
|
URL:
|
https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-002943-28 |
|
Study type:
|
Interventional clinical trial of medicinal product |
|
Study design:
|
Controlled: yes
Randomised: yes
Open: yes
Single blind: no
Double blind: no
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: no
Other: no
Other specify the comparator: docetaxel
|
|
Phase:
|
|
|
|
Countries of recruitment
|
|
Estonia
|
Latvia
| | | | | | |
|
Contacts
|
|
Name:
|
|
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
|
|
|
Name:
|
|
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
|
| |
|
Key inclusion & exclusion criteria
|
Inclusion criteria:
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
|
|
Health Condition(s) or Problem(s) studied
|
|
Locally advanced of metastatic recurrent non-small cell lung cancer
|
|
Intervention(s)
|
Product Name: Iressa
Product Code: ZD1839
Pharmaceutical Form: Tablet
Trade Name: Taxotere
Product Name: Docetaxel
Pharmaceutical Form: Intravenous infusion
|
|
Primary Outcome(s)
|
|
Primary end point(s):
|
Secondary Objective: 1. To compare TTP between ZD1839 and docetaxel
2. to compare progression-free rates a 4 months and 6 months between ZD1839 and docetaxel
3. to compare the overall objective tumor response rate between ZD1839 and docetaxel
4. to compare patient-reported functionally (PRF) and QoL between ZD1839 and docetaxel
5. to compare safety and tolerability of ZD1839 and docetaxel
|
|
Main Objective: To compare overall survival between ZD1839 and docetaxel
|
|
Secondary ID(s)
|
|
1839IL/0721
|
|
2004-002943-28-LV
|
|
Source(s) of Monetary Support
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|