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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00259064




Registration number
NCT00259064
Ethics application status
Date submitted
25/11/2005
Date registered
29/11/2005
Date last updated
2/06/2016

Titles & IDs
Public title
Iressa v BSC (Best Supportive Care) in First Line NSCLC
Scientific title
A Phase II Multicentre Randomised, Parallel Group, Double-Blind, Placebo-Controlled Study of ZD1839 (IRESSATM) (250MG Tablet) Plus Best Supportive Care (BSC) Versus Placebo Plus BSC in Chemotherapy-Naive Patients With Advanced (Stage IIIB or IV) Non-Small Cell Lung Cancer (NSCLC) and Poor Performance Status
Secondary ID [1] 0 0
D7913C00711
Secondary ID [2] 0 0
1839IL/0711
Universal Trial Number (UTN)
Trial acronym
INSTEP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
NSCLC 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Non small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experimental: Gefitinib - ZD1839 + BSC (best supportive care)

Placebo comparator: Placebo - Placebo + BSC (best supportive care)
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To compare Iressa v best supportive care in terms of progression free survival
Timepoint [1] 0 0
Progression-free survival
Secondary outcome [1] 0 0
To compare Iressa v best supportive care in terms of objective tumour response rate
Timepoint [1] 0 0
Overall objective tumour response rate (CR and PR) according to the RECIST criteria
Secondary outcome [2] 0 0
To compare Iressa v best supportive care in terms of overall survival
Timepoint [2] 0 0
Time to death
Secondary outcome [3] 0 0
To compare Iressa v best supportive care in terms of quality of life
Timepoint [3] 0 0
Improvement in patient-reported functionality as measured by trial outcome index, comprised of the physical and functional well being sections and LCS of FACT-L and quality of life measured by the FACT-L total score
Secondary outcome [4] 0 0
To compare Iressa v best supportive care in terms of tolerability
Timepoint [4] 0 0
Adverse event profile (type, frequency and severity of adverse events); laboratory parameters and vital signs

Eligibility
Key inclusion criteria
* Histologically or cytologically confirmed NSCLC
* NSCLC - locally advanced (Stage IIIB) or metastatic (stage IV) disease, not amenable to curative surgery or radiotherapy
* Not suitable for chemotherapy
* WHO Performance status 2 or 3
Minimum age
18 Years
Maximum age
130 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Newly diagnosed CNS mets
* Less than 4 weeks since completion of radiotherapy or persistence of any radiotherapy related toxicity
* Other co-existing malignancies
* 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?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
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
1/09/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2016
Sample size
Target
Accrual to date
Final
216
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Bedford Park
Recruitment hospital [2] 0 0
Research Site - Chermside
Recruitment hospital [3] 0 0
Research Site - Concord
Recruitment hospital [4] 0 0
Research Site - Melbourne
Recruitment hospital [5] 0 0
Research Site - Newcastle
Recruitment hospital [6] 0 0
Research Site - Prahran
Recruitment hospital [7] 0 0
Research Site - Randwick
Recruitment postcode(s) [1] 0 0
- Bedford Park
Recruitment postcode(s) [2] 0 0
- Chermside
Recruitment postcode(s) [3] 0 0
- Concord
Recruitment postcode(s) [4] 0 0
- Melbourne
Recruitment postcode(s) [5] 0 0
- Newcastle
Recruitment postcode(s) [6] 0 0
- Prahran
Recruitment postcode(s) [7] 0 0
- Randwick
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Alberta
Country [2] 0 0
Canada
State/province [2] 0 0
British Columbia
Country [3] 0 0
Canada
State/province [3] 0 0
Manitoba
Country [4] 0 0
Canada
State/province [4] 0 0
New Brunswick
Country [5] 0 0
Canada
State/province [5] 0 0
Nova Scotia
Country [6] 0 0
Canada
State/province [6] 0 0
Ontario
Country [7] 0 0
Czech Republic
State/province [7] 0 0
Nova Ves pod Plesi
Country [8] 0 0
Netherlands
State/province [8] 0 0
Amsterdam
Country [9] 0 0
Netherlands
State/province [9] 0 0
Den Bosch
Country [10] 0 0
Netherlands
State/province [10] 0 0
Den Haag
Country [11] 0 0
Netherlands
State/province [11] 0 0
Eindhoven
Country [12] 0 0
Netherlands
State/province [12] 0 0
Zutphen
Country [13] 0 0
United Kingdom
State/province [13] 0 0
Abergavenny
Country [14] 0 0
United Kingdom
State/province [14] 0 0
Birmingham
Country [15] 0 0
United Kingdom
State/province [15] 0 0
Cardiff
Country [16] 0 0
United Kingdom
State/province [16] 0 0
Leeds
Country [17] 0 0
United Kingdom
State/province [17] 0 0
Wolverhampton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of the study is to determine if the addition of Iressa to Best Supportive Care treatment will increase the progression free survival of chemo-naïve, poor performance status patients, with stage IIIB or IV NSCLC.
Trial website
https://clinicaltrials.gov/study/NCT00259064
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
AstraZeneca Iressa Medical Science Director, MD
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/study/NCT00259064