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A Double Blind,Placebo Controlled,Parallel Group,Multicentre,Randomised,Phase Iii Survival Study Comparing ZD1839 (IRESSA™)(250mg Tablet) Plus Best Supportive Care Versus Placebo Plus Best Supportive Care In Patients With Advanced NSCLC Who Have Received One Or Two Prior Chemotherapy Regimens And Are Refractory Or Intolerant To Their Most Recent Regimen


Phase 3
18 Years
N/A
Not Enrolling
Both
NSCLC

Thank you

Trial Information

A Double Blind,Placebo Controlled,Parallel Group,Multicentre,Randomised,Phase Iii Survival Study Comparing ZD1839 (IRESSA™)(250mg Tablet) Plus Best Supportive Care Versus Placebo Plus Best Supportive Care In Patients With Advanced NSCLC Who Have Received One Or Two Prior Chemotherapy Regimens And Are Refractory Or Intolerant To Their Most Recent Regimen


Inclusion Criteria:



- · Life expectancy of at least 8 weeks.

- Histologically or cytologically confirmed non-small cell bronchogenic carcinoma:
adenocarcinoma (including bronchoalveolar), squamous cell carcinoma, large cell
carcinoma or mixed (adenocarcinoma and squamous) or undifferentiated carcinoma

- Not suitable for chemotherapy

- WHO Performance status 0,1, 2 or 3

Exclusion Criteria:

- Newly diagnosed CNS mets

- Less than 1 week since completion of prior radiotherapy or persistence of any
radiotherapy related toxicity

- 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Outcome Measure:

The primary objective of this study is to compare overall survival for ZD1839 plus best supportive care versus placebo plus best supportive care

Principal Investigator

AstraZeneca Oncology Medical Science Direction

Investigator Role:

Study Director

Investigator Affiliation:

AstraZeneca

Authority:

United States: Food and Drug Administration

Study ID:

1839IL/0709

NCT ID:

NCT00242801

Start Date:

July 2003

Completion Date:

April 2005

Related Keywords:

  • NSCLC

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