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A Phase I Study of ZD1839 (Iressa) and Palliative Thoracic Radiotherapy in Patients With Non-small Cell Lung Cancer


Phase 1
18 Years
N/A
Not Enrolling
Both
Non-small-cell Lung Cancer

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Trial Information

A Phase I Study of ZD1839 (Iressa) and Palliative Thoracic Radiotherapy in Patients With Non-small Cell Lung Cancer


Inclusion Criteria:



- Provision of written informed consent

- Patients requiring low dose palliative thoracic irradiation to a field size of less
than or equal to 150cm2

- Histologically or cytologically conformed non-small cell lung cancer

- Aged 18 or over

Exclusion Criteria:

- Previous thoracic radiotherapy

- Any condition that may pre-dispose the patient to suffer an individual drug-relaged
DLT (dose limiting toxicity) event

- Known hypersensitivity to any component of study medication

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To characterize the safety profile of ZD 1839 in these patients

Principal Investigator

AstraZeneca Iressa Medical Sciences Director, MD

Investigator Role:

Study Director

Investigator Affiliation:

AstraZeneca

Authority:

United Kingdom: Department of Health

Study ID:

1839IL/0524

NCT ID:

NCT00255489

Start Date:

May 2004

Completion Date:

June 2006

Related Keywords:

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

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