Ignite Creation Date:
2024-05-05 @ 12:06 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00242788
Status:
COMPLETED
Last Update Posted:
2009-04-23
First Post:
2005-10-20
Brief Title:
IRESSA In Combo With Xeloda in Advanced Colorectal Cancer Patients After 1st-Line Chemo Failure
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
A Phase III Multicentre Clinical Study Of ZD1839 Iressa In Combination With Capecitabine Xeloda In Subjects With Advanced Colorectal Carcinoma After Failure Of First-Line Chemotherapy
Status:
COMPLETED
Status Verified Date:
2009-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None