Study Evaluating Gefitinib (IRESSA®) in Subjects With Solid Malignancies That Are Locally Advanced, Recurrent or Metastatic (AGUS)

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Tumors

Treatments: Drug: Gefitinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT00127829

D7913C00022

Details and patient eligibility

About

This study will determine the safety profile and maximum tolerated dose (MTD) of orally administered gefitinib on a weekly and twice weekly schedule.

Enrollment: 66 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically confirmed solid tumor refractory to conventional treatment or whom no standard of treatment exists
• Life expectancy of > 12 weeks
• World Health Organization (WHO) performance status of < 2

Exclusion criteria

• Known severe hypersensitivity to gefitinib or any of the excipients of this product
• Less than 4 weeks since completion of prior chemotherapy or radiation therapy (except nitrosoureas or mitomycin-C which must have a wash out period of 6 weeks)
• Incomplete healing from previous oncologic or other major surgery

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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66 participants in 1 patient group

1

Experimental group

Description:

Gefitinib (IRESSA®)

Treatment:

Drug: Gefitinib