Ignite Creation Date:
2024-05-05 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00081536
Status:
UNKNOWN
Last Update Posted:
2005-06-24
First Post:
2004-04-15
Brief Title:
Aroplatin and Capecitabine in Patients With Advanced Colorectal Cancer Resistant to Standard Therapies
Sponsor:
Aronex Pharmaceuticals
Organization:
Aronex Pharmaceuticals
Study Overview
Official Title:
A Phase III Study of Aroplatin and Capecitabine in Subjects With Unresectable Local Recurrence or Distant Metastases of Colorectal Cancer Refractory to 5-FULeucovorin and Irinotecan
Status:
UNKNOWN
Status Verified Date:
2004-04
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is a Phase III study In Phase I of this study the objective is to determine the maximum tolerated dose MTD of combination therapy with Aroplatin and capecitabine in subjects with unresectable local recurrence or distant metastases of colorectal cancer refractory to 5-FUleucovorin and irinotecan In Phase II the primary objective is to evaluate the response proportion and duration with Aroplatincapecitabine therapy Secondary objectives are to evaluate frequency and severity of adverse events
Detailed Description:
Phase I Primary Objective
Determine the MTD of Aroplatincapecitabine subjects with unresectable local recurrence or distant metastases of colorectal cancer refractory to 5-FULV and irinotecan
Phase II Primary Objective
Evaluate the response proportion and duration with Aroplatincapecitabine therapy
Phase II Secondary Objective
Evaluate the frequency of adverse events
Determine the MTD of Aroplatincapecitabine subjects with unresectable local recurrence or distant metastases of colorectal cancer refractory to 5-FULV and irinotecan
Phase II Primary Objective
Evaluate the response proportion and duration with Aroplatincapecitabine therapy
Phase II Secondary Objective
Evaluate the frequency of adverse events
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