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NCT00635973 Clinical Trial

Open-Label Extension of Other SZ1839 (Iressa) Trials

Cancer Clinical Trial

Official title:
Multi-Centre, Open-Label Extension Trial of Treatment With ZD1839 (Iressa) in Patients Who Have Been Treated in Other ZD1839 Clinical Trials and May Benefit From Continued Monotherapy ZD 1839.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00635973
Other study ID # 1839IL/0026
Secondary ID D7913C00026
Status Completed
Phase Phase 3
First received March 7, 2008
Last updated April 21, 2009
Start date February 2000
Est. completion date October 2003

Study information
Verified date April 2009
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationAustralia: Department of Health and Ageing Therapeutic Goods AdministrationGermany: Federal Institute for Drugs and Medical DevicesSpain: Spanish Agency of MedicinesFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)United Kingdom: Medicines and Healthcare Products Regulatory AgencyItaly: Ministry of HealthJapan: Pharmaceuticals and Medical Devices AgencyNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)South Africa: Department of Health
Study type Interventional

Clinical Trial Summary

A trial to assess patients who have been treated with Iressa in a previous clinical trial and may benefit from continued treatment with Iressa.

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date October 2003
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Received treatment in a previous Iressa clinical trial

- Provided Informed Consent to participate in the trial

- 30 days or less since completing the previous Iressa trial.

Exclusion Criteria:

- Radiotherapy completed more than 14 days before starting treatment in this trial

- Incomplete healing from prior surgery

- Withdrawal from previous Iressa trial due to unacceptable toxicity to major organs

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Gefitinib (Iressa)
Iressa

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
AstraZeneca

Outcome
Type Measure Description Time frame Safety issue
Primary Adverse Events Every 28 days
Secondary Progression Free Survival Every 28 days
Secondary Survival Every 28 days
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