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Sponsored by: |
AstraZeneca |
---|---|
Information provided by: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00242788 |
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).
Condition | Intervention | Phase |
---|---|---|
Colorectal Cancer |
Drug: Gefitinib and capecitabine |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
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 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Spain | |
Research Site | |
Santander, Spain | |
Research Site | |
Malaga, Spain | |
Research Site | |
Madrid, Spain | |
Research Site | |
Leganes, Spain | |
Research Site | |
Gerona, Spain | |
Research Site | |
Zaragoza, Spain |
Study Director: | AstraZeneca Spain Medical Director, MD | AstraZeneca |
Study ID Numbers: | 1839IL/0505 |
Study First Received: | October 20, 2005 |
Last Updated: | April 22, 2009 |
ClinicalTrials.gov Identifier: | NCT00242788 History of Changes |
Health Authority: | Spain: Spanish Agency of Medicines |
Colorectal Cancer |
Antimetabolites Capecitabine Digestive System Neoplasms Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases |
Intestinal Neoplasms Carcinoma Digestive System Diseases Gastrointestinal Neoplasms Gefitinib Colorectal Neoplasms |
Antimetabolites Capecitabine Digestive System Neoplasms Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Gastrointestinal Diseases Colonic Diseases Intestinal Diseases |
Rectal Diseases Pharmacologic Actions Intestinal Neoplasms Neoplasms Neoplasms by Site Digestive System Diseases Therapeutic Uses Gastrointestinal Neoplasms Colorectal Neoplasms |