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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00242801




Registration number
NCT00242801
Ethics application status
Date submitted
19/10/2005
Date registered
21/10/2005
Date last updated
23/04/2009

Titles & IDs
Public title
Iressa vs Best Supportive Care - 2nd/3rd Line Survival Study
Scientific title
A Double Blind,Placebo Controlled,Parallel Group,Multicentre,Randomised,Phase Iii Survival Study Comparing ZD1839 (IRESSA™)(250mg Tablet) Plus Best Supportive Care Versus Placebo Plus Best Supportive Care In Patients With Advanced NSCLC Who Have Received One Or Two Prior Chemotherapy Regimens And Are Refractory Or Intolerant To Their Most Recent Regimen
Secondary ID [1] 0 0
ISEL
Secondary ID [2] 0 0
1839IL/0709
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
NSCLC 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Gefitinib

Treatment: Drugs: Gefitinib
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The primary objective of this study is to compare overall survival for ZD1839 plus best supportive care versus placebo plus best supportive care
Timepoint [1] 0 0
Secondary outcome [1] 0 0
· ZD1839 + BSC versus Placebo + BSC in terms of time to treatment failure
Timepoint [1] 0 0
Secondary outcome [2] 0 0
· ZD1839 + BSC versus Placebo + BSC in terms of investigator assessed overall
Timepoint [2] 0 0
Secondary outcome [3] 0 0
· objective tumour response (CR + PR)
Timepoint [3] 0 0
Secondary outcome [4] 0 0
· ZD1839 + BSC versus Placebo + BSC in terms of tolerability
Timepoint [4] 0 0
Secondary outcome [5] 0 0
· ZD1839 + BSC versus Placebo + BSC in terms of quality of life changes
Timepoint [5] 0 0

Eligibility
Key inclusion criteria
- · Life expectancy of at least 8 weeks.

- Histologically or cytologically confirmed non-small cell bronchogenic carcinoma:
adenocarcinoma (including bronchoalveolar), squamous cell carcinoma, large cell
carcinoma or mixed (adenocarcinoma and squamous) or undifferentiated carcinoma

- Not suitable for chemotherapy

- WHO Performance status 0,1, 2 or 3
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Newly diagnosed CNS mets

- Less than 1 week since completion of prior radiotherapy or persistence of any
radiotherapy related toxicity

- ALT/AST greater than 5 x upper limit of normal

- ANC less than 1.0 x 109/L or platelets less than 100 x 109/L

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2003
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2005
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Research Site - Concord
Recruitment hospital [2] 0 0
Research Site - Potts Point
Recruitment hospital [3] 0 0
Research Site - St. Leonards
Recruitment hospital [4] 0 0
Research Site - Chermside
Recruitment hospital [5] 0 0
Research Site - South Brisbane
Recruitment hospital [6] 0 0
Research Site - Ashford
Recruitment hospital [7] 0 0
Research Site - Woodville
Recruitment hospital [8] 0 0
Research Site - Melbourne
Recruitment hospital [9] 0 0
Research Site - Parkville
Recruitment hospital [10] 0 0
Research Site - Prahran
Recruitment hospital [11] 0 0
Research Site - Wodonga
Recruitment hospital [12] 0 0
Research Site - Woodville South
Recruitment postcode(s) [1] 0 0
- Concord
Recruitment postcode(s) [2] 0 0
- Potts Point
Recruitment postcode(s) [3] 0 0
- St. Leonards
Recruitment postcode(s) [4] 0 0
- Chermside
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- South Brisbane
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- Ashford
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- Woodville
Recruitment postcode(s) [8] 0 0
- Melbourne
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- Parkville
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- Prahran
Recruitment postcode(s) [11] 0 0
- Wodonga
Recruitment postcode(s) [12] 0 0
- Woodville South
Recruitment outside Australia
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Argentina
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study is being carried out to see if adding ZD1839 to other standard supportive care is
more effective than standard supportive care alone for the treatment of patients with NSCLC
whose disease has recurred after previous chemotherapy treatment.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00242801
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
AstraZeneca Oncology Medical Science Direction
Address 0 0
AstraZeneca
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00242801