Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00081549
Status:
UNKNOWN
Last Update Posted:
2005-06-24
First Post:
2004-04-15
Brief Title:
Aroplatin and Gemcitabine in Patients With Advanced Pancreatic Cancer Resistant to Standard Therapies
Sponsor:
Aronex Pharmaceuticals
Organization:
Aronex Pharmaceuticals
Study Overview
Official Title:
A Phase III Study of Aroplatin and Gemcitabine In Subjects With Unresectable Locally Advanced AndOr Metastatic Pancreatic Cancer
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 gemcitabine Gemzar in subjects with unresectable locally advanced andor metastatic pancreatic cancer In Phase II the primary objective is to evaluate survival after therapy with Aroplatin and gemcitabine at the identified MTD in subjects with unresectable locally advanced andor metastatic pancreatic cancer Secondary objectives are to evaluate the severity and quantity of adverse events and determine the proportion of non-progressors and the progression-free interval
Detailed Description:
Phase I Primary Objective
Determine the maximum tolerated dose MTD of combination therapy with Aroplatin and gemcitabine Gemzar in subjects with unresectable locally advanced andor metastatic pancreatic cancer
Phase II Primary Objective
Evaluate survival after therapy with Aroplatin and gemcitabine at the MTD in subjects with unresectable locally advanced andor metastatic pancreatic cancer
Phase II Secondary Objective
Evaluate the severity and quantity of adverse events and determine the proportion of non-progressors and the progression-free interval
Determine the maximum tolerated dose MTD of combination therapy with Aroplatin and gemcitabine Gemzar in subjects with unresectable locally advanced andor metastatic pancreatic cancer
Phase II Primary Objective
Evaluate survival after therapy with Aroplatin and gemcitabine at the MTD in subjects with unresectable locally advanced andor metastatic pancreatic cancer
Phase II Secondary Objective
Evaluate the severity and quantity of adverse events and determine the proportion of non-progressors and the progression-free interval
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