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A Randomised, Double-blind, Parallel-group, Dose Finding Study to Assess the Efficacy and Safety of ZD6474 in Patients With Advanced, Metastatic, or Recurrent NSCLC Who Have Failed Previous Chemotherapy Regimens, at Least One of Which Contained Platinum [Title Abbreviated]


Phase 2
20 Years
N/A
Not Enrolling
Both
Non Small Cell Lung Carcinoma

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Trial Information

A Randomised, Double-blind, Parallel-group, Dose Finding Study to Assess the Efficacy and Safety of ZD6474 in Patients With Advanced, Metastatic, or Recurrent NSCLC Who Have Failed Previous Chemotherapy Regimens, at Least One of Which Contained Platinum [Title Abbreviated]


Inclusion Criteria:



- Provision of written informed consent.

- Life expectancy of 12 weeks or longer.

Exclusion Criteria:

- Pregnancy, breast feeding or female patients wishing to become pregnant.

- Treatment with a non-approved or investigational drug within 30 days before enrolment

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

To assess the objective response rates (by RECIST) to ZD6474 100, 200 and 300 mg/day respectively

Principal Investigator

AstraZeneca Japan Medical Director, MD

Investigator Role:

Study Director

Investigator Affiliation:

AstraZeneca

Authority:

Japan: Pharmaceuticals and Medical Devices Agency

Study ID:

D4200C00039

NCT ID:

NCT00252746

Start Date:

December 2004

Completion Date:

January 2007

Related Keywords:

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

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