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Multicentre, Open Label, Extension Study of Treatment With Gefitinib(IRESSA™) for Patients Completing Other Gefitinib Clinical Studies Who May Benefit From Gefitinib Treatment


Phase 3
N/A
N/A
Open (Enrolling)
Both
Non Small Cell Lung Cancer (NSCLC)

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Trial Information

Multicentre, Open Label, Extension Study of Treatment With Gefitinib(IRESSA™) for Patients Completing Other Gefitinib Clinical Studies Who May Benefit From Gefitinib Treatment


Inclusion Criteria:



- Patients who have completed preceding gefitinib therapy from either the 1839IL/0709
(250mg dosing) study or 1839IL/0710 (250mg dosing) study and in the opinion of the
investigator may benefit from further gefitinib treatment.

- No more than 14 days lapse in gefitinib treatment between the patient completing the
preceding gefitinib clinical study and beginning of this study except when agreed by
the AstraZeneca physician.

Exclusion Criteria:

- Any evidence of clinically active interstitial lung disease (patients with
chronic,stable, radiographic changes who are asymptomatic need not be excluded).

- In the opinion of the investigator, any evidence of severe or uncontrolled systemic
disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal
disease).

- Withdrawal, at any time, from the preceding gefitinib study.

- Concomitant use of phenytoin, carbamazepine, rifampicin, barbiturates, or St John's
Wort

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

There are no outcome variables in this programme. No formal analysis or statistical analysis will be performed on any data obtained. Serious adverse event data will be collected for regulatory reporting purposes only.

Outcome Time Frame:

Study medication will continue until the patient shows disease progression, disease related symptomatic progression, withdraws consent or experiences toxicity leading to withdrawal ofstudy treatment.

Safety Issue:

No

Principal Investigator

Alison Armour

Investigator Role:

Study Director

Investigator Affiliation:

AstraZeneca

Authority:

Austria: Ethikkommission

Study ID:

D791AC00008

NCT ID:

NCT00683306

Start Date:

January 2005

Completion Date:

June 2013

Related Keywords:

  • Non Small Cell Lung Cancer (NSCLC)
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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