A Phase I Study of ZD1839 and Palliative Thoracic Radiotherapy in Patients With Non-small-cell Lung Cancer

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Non-small-cell Lung Cancer

Treatments: Procedure: palliative thoracic radiotherapy; Drug: Gefitinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT00255489

1839IL/0524

Details and patient eligibility

About

The purpose of this study is to characterize the safety profile of ZD1839 in combination with Palliative thoracic Radiotherapy in patients with non-small cell lung cancer

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)