A Phase II Exploratory, Multicentre, Open-label, Non-comparative Study of ZD1839 (Iressa) and Radiotherapy in the Treatment of Patients With Glioblastoma Multiforme

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Glioblastoma

Treatments: Drug: Gefitinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT00238797

D7913L00088 (Other Identifier)

1839IL/0088

Details and patient eligibility

About

The purpose of the study is to determine the efficacy of gefitinib (IressaTM) in combination with radiotherapy on patients with glioblastoma multiforme.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Signed informed consent
• histologically-or cytologically-confirmed glioblastoma multiforme
• age 18 years or older

Exclusion criteria

• Have had prior radiation therapy, immunotherapy, gene therapy and/or chemotherapy for the glioblastoma
• co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ
• known severe hypersensitivity to ZD1839 or any of the excipients of this product.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)