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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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00259064