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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/NCT00256711




Registration number
NCT00256711
Ethics application status
Date submitted
20/11/2005
Date registered
22/11/2005
Date last updated
23/04/2009

Titles & IDs
Public title
Phase II Iressa Versus Vinorelbine (INVITE)
Scientific title
A Randomised, Open Label, Parallel Group, Multi-Centre, Phase II Study of Progression Free Survival Comparing ZD1839 (IRESSA™) (250 MG Tablet) Versus Vinorelbine (30 MG/M2 Infusion) in Chemonaive, Elderly Patients With Locally Advanced (Stage IIIB) or Metastatic (Stage IV) NSCLC
Secondary ID [1] 0 0
INVITE
Secondary ID [2] 0 0
D791AC00001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-Small-Cell Lung Carcinoma 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
Treatment: Drugs - Gefitinib
Treatment: Drugs - Vinorelbine

Treatment: Drugs: Gefitinib


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

Outcomes
Primary outcome [1] 0 0
To compare ZD1839 and vinorelbine in terms of progression free survival
Timepoint [1] 0 0
Secondary outcome [1] 0 0
To compare ZD1839 and vinorelbine in terms of pulmonary symptom improvement weekly for 18 weeks.
Timepoint [1] 0 0
Secondary outcome [2] 0 0
To compare ZD1839 and vinorelbine in terms of quality of life 3 weekly for 18 weeks then 6 weekly.
Timepoint [2] 0 0
Secondary outcome [3] 0 0
To compare ZD1839 and vinorelbine in terms of adverse event profile continuous monitoring.
Timepoint [3] 0 0
Secondary outcome [4] 0 0
To compare ZD1839 and vinorelbine in terms of overall objective tumour response rate (complete response and partial response) 6 weekly to progression.
Timepoint [4] 0 0
Secondary outcome [5] 0 0
To compare ZD1839 and vinorelbine in terms of overall survival (time to death) continuous monitoring
Timepoint [5] 0 0

Eligibility
Key inclusion criteria
- Histologically confirmed NSCLC and willing to provide paraffin embedded tumour tissue

- NSCLC - locally advanced (Stage IIIB) or metastatic (stage IV) disease, not amenable
to curative surgery or radiotherapy chemonaïve, life expectancy of 12 weeks

- WHO Performance status <= 2
Minimum age
70 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Newly diagnosed CNS metastases

- Less than 4 weeks since completion of radiotherapy or persistence of any radiotherapy
related toxicity.

- Hypersensitivity to ZD1839 or intravenous vinorelbine

- Prior treatment with EGFR inhibitors

- Other co-existing malignancies

- ALT/AST >2.5 x ULRR

- ANC < 2.0 x 10^9/L or platelets < 100 x 10^9/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
Open (masking not used)
Who is / are masked / blinded?



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
1/07/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2006
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,WA
Recruitment hospital [1] 0 0
Research Site - St. Leonards
Recruitment hospital [2] 0 0
Research Site - Westmead
Recruitment hospital [3] 0 0
Research Site - South Brisbane
Recruitment hospital [4] 0 0
Research Site - Nedlands
Recruitment hospital [5] 0 0
Research Site - Victoria
Recruitment postcode(s) [1] 0 0
- St. Leonards
Recruitment postcode(s) [2] 0 0
- Westmead
Recruitment postcode(s) [3] 0 0
- South Brisbane
Recruitment postcode(s) [4] 0 0
- Nedlands
Recruitment postcode(s) [5] 0 0
- Victoria
Recruitment outside Australia
Country [1] 0 0
Brazil
State/province [1] 0 0
CE
Country [2] 0 0
Brazil
State/province [2] 0 0
GO
Country [3] 0 0
Brazil
State/province [3] 0 0
RJ
Country [4] 0 0
Brazil
State/province [4] 0 0
SP
Country [5] 0 0
Czech Republic
State/province [5] 0 0
CZ
Country [6] 0 0
Czech Republic
State/province [6] 0 0
Hradec Kralove
Country [7] 0 0
Czech Republic
State/province [7] 0 0
Kutná Hora
Country [8] 0 0
Czech Republic
State/province [8] 0 0
Olomouc
Country [9] 0 0
Czech Republic
State/province [9] 0 0
Ostrava - Poruba
Country [10] 0 0
Czech Republic
State/province [10] 0 0
Ostrava
Country [11] 0 0
Czech Republic
State/province [11] 0 0
Plzen
Country [12] 0 0
France
State/province [12] 0 0
Marseille Cedex 09
Country [13] 0 0
France
State/province [13] 0 0
Montpellier Cedex 5
Country [14] 0 0
France
State/province [14] 0 0
Montpellier Cedex
Country [15] 0 0
France
State/province [15] 0 0
Pierre Benite Cedex
Country [16] 0 0
France
State/province [16] 0 0
Vesoul Cedex
Country [17] 0 0
Germany
State/province [17] 0 0
Baden-Württemberg
Country [18] 0 0
Germany
State/province [18] 0 0
Bayern
Country [19] 0 0
Germany
State/province [19] 0 0
Sachsen-Anhalt
Country [20] 0 0
Germany
State/province [20] 0 0
Schleswig-Holstein
Country [21] 0 0
Germany
State/province [21] 0 0
Berlin
Country [22] 0 0
Germany
State/province [22] 0 0
Großhansdorf
Country [23] 0 0
Germany
State/province [23] 0 0
Halle
Country [24] 0 0
Germany
State/province [24] 0 0
Hamburg
Country [25] 0 0
Germany
State/province [25] 0 0
Mainz
Country [26] 0 0
Italy
State/province [26] 0 0
Ancona
Country [27] 0 0
Italy
State/province [27] 0 0
BG
Country [28] 0 0
Italy
State/province [28] 0 0
BO
Country [29] 0 0
Italy
State/province [29] 0 0
CT
Country [30] 0 0
Italy
State/province [30] 0 0
MI
Country [31] 0 0
Italy
State/province [31] 0 0
MO
Country [32] 0 0
Italy
State/province [32] 0 0
PR
Country [33] 0 0
Italy
State/province [33] 0 0
TO
Country [34] 0 0
Italy
State/province [34] 0 0
Napoli
Country [35] 0 0
Korea, Republic of
State/province [35] 0 0
Seoul
Country [36] 0 0
South Africa
State/province [36] 0 0
Cape Town
Country [37] 0 0
South Africa
State/province [37] 0 0
Durban
Country [38] 0 0
Taiwan
State/province [38] 0 0
Taichung
Country [39] 0 0
Taiwan
State/province [39] 0 0
Taipei
Country [40] 0 0
United Kingdom
State/province [40] 0 0
Cambrideshire
Country [41] 0 0
United Kingdom
State/province [41] 0 0
West Midlands
Country [42] 0 0
United Kingdom
State/province [42] 0 0
Aberdeen
Country [43] 0 0
United Kingdom
State/province [43] 0 0
Dundee
Country [44] 0 0
United Kingdom
State/province [44] 0 0
Glasgow
Country [45] 0 0
United Kingdom
State/province [45] 0 0
Nottingham
Country [46] 0 0
United Kingdom
State/province [46] 0 0
Sheffield

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

Ethics approval
Ethics application status

Summary
Brief summary
This is a randomized, open label, parallel group, multi-centre, phase II study of progression
free survival, comparing oral ZD1839 (IRESSA™) (250 mg tablet once daily) to vinorelbine 30
mg/m2 infusion on days 1 and 8 of a 21-day cycle) in chemonaïve, elderly patients with
locally advanced (stage IIIB) or metastatic (stage IV) non-small cell lung cancer.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00256711
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