Colorectal Cancer Clinical Trial
Official title:
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
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).
n/a
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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