Ignite Creation Date:
2024-05-06 @ 12:30 AM
Last Modification Date:
2024-10-26 @ 10:51 AM
Study NCT ID:
NCT01594918
Status:
COMPLETED
Last Update Posted:
2017-07-21
First Post:
2012-05-07
Brief Title:
Phase I Cabazitaxel Mitoxantrone and Prednisone Metastatic Castration-Resistant Prostate Cancer
Sponsor:
Rahul Aggarwal
Organization:
University of California San Francisco
Study Overview
Official Title:
A Phase I Study of Cabazitaxel Mitoxantrone and Prednisone CAMP for Patients With Metastatic Castration-Resistant Prostate Cancer and no Prior Chemotherapy
Status:
COMPLETED
Status Verified Date:
2017-07
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 purpose of this study is to test the safety of cabazitaxel mitoxantrone and prednisone CAMP in combination at different dose levels and to determine the highest dose that does not cause bad side effects The investigators want to find out what effects good andor bad CAMP has on patients and their metastatic castration-resistant prostate cancer
Detailed Description:
This is a Phase I open label dose-finding multicenter clinical trial to establish the maximum tolerated dose MTD and dose limiting toxicities DLT of cabazitaxel 25 mgm2 IV q21 days in combination with mitoxantrone 4-12 mgm2 IV q21 days and prednisone 5mg orally BID in patients with metastatic CRPC who have not undergone prior chemotherapy for metastatic disease
Up to five cohorts will be enrolled to determine the MTD and DLT profile of this combination An accelerated titration design method is being used in order to minimize the number of patients exposed to subtherapeutic doses of mitoxantrone
Up to five cohorts will be enrolled to determine the MTD and DLT profile of this combination An accelerated titration design method is being used in order to minimize the number of patients exposed to subtherapeutic doses of mitoxantrone
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