Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00043199
Status:
UNKNOWN
Last Update Posted:
2005-06-24
First Post:
2002-08-06
Brief Title:
A Safety and Effectiveness Study of Aroplatin in Patients With Advanced Colorectal Cancer Resistant to Standard Therapies
Sponsor:
Aronex Pharmaceuticals
Organization:
Aronex Pharmaceuticals
Study Overview
Official Title:
A Phase II Study of Aroplatin in Subjects With Recurrent Unresectable and Metastatic Colorectal Cancer Refractory to 5-Fluorouracil 5-FULeucovorin or Capecitabine 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:
To determine the rate of response and duration of reponse following therapy with Aroplatin in subjects with advanced colorectal cancer resistant to standard therapies Secondary objectives are to determine safety and tolerability of the Aroplatin therapy
Detailed Description:
Primary Objective
To determine response rate RR complete and partial responseCRPR and duration after therapy with Aroplatin Liposomal NDDP L-NDDP in subjects with locally recurrent unresectable or metastatic colorectal cancer refractory to 5-FUleucovorin or capecitabine and irinotecan
Secondary Objective
To determine safety and tolerability of the Aroplatin therapy
This is a single-arm open-label phase II study Subjects refractory to 5-FUleucovorin or capecitabine and irinotecan therapies will be enrolled Dosing will be every four weeks with individual dose escalations and adjustments for toxicity
To determine response rate RR complete and partial responseCRPR and duration after therapy with Aroplatin Liposomal NDDP L-NDDP in subjects with locally recurrent unresectable or metastatic colorectal cancer refractory to 5-FUleucovorin or capecitabine and irinotecan
Secondary Objective
To determine safety and tolerability of the Aroplatin therapy
This is a single-arm open-label phase II study Subjects refractory to 5-FUleucovorin or capecitabine and irinotecan therapies will be enrolled Dosing will be every four weeks with individual dose escalations and adjustments for toxicity
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