A Phase I/II, Multicentre Clinical Study Of ZD1839 (Iressa™) In Combination With Capecitabine (Xeloda™) In Subjects With Advanced Colorectal Carcinoma After Failure Of First-Line Chemotherapy

NCT00242788 Phase 1/Phase 2 COMPLETED

The primary objective of the Phase I part of the study is to determine the recommended dose of capecitabine to be administered in combination with ZD1839 250 mg orally once daily in subjects with advanced or metastatic colorectal cancer by assessing DLTs. The primary objective of the Phase II part of the study is to estimate the objective response rate (complete response \[CR\] and partial response \[PR\]) at study closure for ZD1839 administered in combination with capecitabine in subjects with advanced or metastatic colorectal cancer using the Response Evaluation Criteria in Solid Tumours (RECIST).

Details

Lead sponsor	AstraZeneca
Phase	Phase 1/Phase 2
Status	COMPLETED
Enrolment	40
Start date	2004-02
Completion	2005-11

Conditions

• Colorectal Cancer

Interventions

• Gefitinib and capecitabine

Primary outcomes

• Objective tumour response (CR and PR) at study closure based on the RECIST

Countries

Spain