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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:	EUCTR2004-004206-25-CZ
Date of registration:	03/04/2006
Prospective Registration:	Yes
Primary sponsor:	AstraZeneca AB
Public title:	A PHASE II MULTICENTRE RANDOMISED, PARALLEL GROUP, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF ZD1839 (IRESSA TM) (250MG TABLET) PLUS BEST SUPPORTIVE CARE (BSC) VERSUS PLACEBO PLUS BSC IN CHEMOTHERAPY-NAÏVE PATIENTS WITH ADVANCED (STAGE IIIB OR IV) NON-SMALL CELL LUNG CANCER (NSCLC) AND POOR PERFORMANCE STATUS - INSTEP
Scientific title:	A PHASE II MULTICENTRE RANDOMISED, PARALLEL GROUP, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF ZD1839 (IRESSA TM) (250MG TABLET) PLUS BEST SUPPORTIVE CARE (BSC) VERSUS PLACEBO PLUS BSC IN CHEMOTHERAPY-NAÏVE PATIENTS WITH ADVANCED (STAGE IIIB OR IV) NON-SMALL CELL LUNG CANCER (NSCLC) AND POOR PERFORMANCE STATUS - INSTEP
Date of first enrolment:	17/05/2006
Target sample size:	200
Recruitment status:	Not Recruiting
URL:	https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-004206-25
Study type:	Interventional clinical trial of medicinal product
Study design:	Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: yes If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no
Phase:

Countries of recruitment
Czech Republic	Ireland

Contacts

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Key inclusion & exclusion criteria

Inclusion criteria:
1.Provision of written informed consent
2.Male or female, aged 18 years and over
3.Histologically or cytological confirmation of non-small cell lung carcinoma: adenocarcinoma (including bronchoalveolar), squamous cell carcinoma, large cell carcinoma or mixed (adenocarcinoma and squamous) or undifferentiated carcinoma. This may be from the initial diagnosis of NSCLC or subsequent biopsy. Note: sputum cytology alone is not acceptable. Cytological specimens obtained by brushing, washing or needle aspiration of a defined lesion are acceptable
4.NSCLC, locally advanced (Stage IIIB) or metastatic (stage IV) disease, not amenable to curative surgery or radiotherapy
5.Measurable disease according to RECIST criteria with at least one measurable lesion not previously irradiated, unless disease progression has been documented at that site.
6.Ability to provide plasma and urine samples for biomarker analysis
7.WHO performance status (PS) of 2 or 3
8.Not considered suitable for chemotherapy
9.No prior chemotherapy, biological or immunological therapy (including adjuvant and neoadjuvant). Prior surgery and/or localized irradiation is allowed
10.Life expectancy of at least 9 weeks

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:
1.Newly diagnosed CNS metastases that have not yet been definitively treated with surgery and/or radiation. Patients with previously diagnosed and treated CNS metastases or spinal cord compression may be considered if they have evidence of clinically stable disease (off steroids or in presence of a tailing steroid dose) for at least 4 weeks
2.Less than 4 weeks since completion of prior radiotherapy or persistence of any radiotherapy related toxicity.
3.Known severe hypersensitivity to ZD1839 or any of the excipients of this product
4.Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ
5.Any unresolved chronic toxicity greater than CTC grade 2 from previous anticancer therapy (except alopecia)
6.As judged by the investigator, any evidence of severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease)
7.Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than
5 times the upper limit of the reference range (ULRR)
8.Absolute neutrophil counts (ANC) less than 1.0 x 109/L or platelets less than
100 x 109/L
9.Serum bilirubin greater than 3 times the upper limit of the reference range (ULRR)
10.Any evidence of clinically active interstitial lung disease (patients with chronic, stable, radiographic changes who are asymptomatic need not be excluded)
11.Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the study
12.Pregnancy or breastfeeding (women of child-bearing potential). Women of childbearing potential must practice acceptable methods of birth control to prevent pregnancy
13.Concomitant use of phenytoin, carbamazepine, rifampicin, barbiturates, or St John’s Wort
14.Prior treatment with EGFR inhibitors
15.Treatment with a non-approved or investigational drug within 30 days before
Day 1 of study treatment

Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Non-Small Cell Lung Cancer

Intervention(s)

Product Name: Iressa (gefitinib)
Product Code: ZD1839
Pharmaceutical Form: Tablet
INN or Proposed INN: gefitinib
Current Sponsor code: 1839IL0711
Other descriptive name: INSTEP
Concentration unit: mg/g milligram(s)/gram
Concentration type: equal
Concentration number: 250-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)

Secondary Objective: 1. To compare ZD1839 + BSC versus placebo + BSC in terms of overall objective tumour response rate (complete response [CR] and partial response [PR])
2. To compare ZD1839 + BSC versus placebo + BSC in terms of overall survival
3. To compare ZD1839 + BSC versus placebo + BSC in terms of pulmonary symptom improvement
4. To compare ZD1839 + BSC versus placebo + BSC in terms of quality of life
5. To compare ZD1839 + BSC versus placebo + BSC in terms of tolerability

Main Objective: To compare ZD1839 + best supportive care (BSC) versus placebo + BSC in terms of progression-free survival

Primary end point(s): Progression-free survival

Secondary Outcome(s)

Secondary ID(s)

2004-004206-25-IE

1839IL/0711

Source(s) of Monetary Support

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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