Ignite Creation Date:
2024-05-05 @ 5:23 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00446836
Status:
COMPLETED
Last Update Posted:
2016-03-17
First Post:
2007-03-12
Brief Title:
Efficacy and Safety Study of Xyotax to Treat Prostate Cancer
Sponsor:
The Methodist Hospital Research Institute
Organization:
The Methodist Hospital Research Institute
Study Overview
Official Title:
Phase II Study of Xyotax in Advanced Hormone Refractory Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2016-03
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 determine whether Xyotax a conjugate of the taxane drug paclitaxel is effective in the treatment of prostate cancer that is no longer responsive to hormone therapy
Detailed Description:
Prostate cancer is the second leading cause of cancer death in American men Hormonal ablation in the form of medical or surgical castration is the cornerstone of management for metastatic prostate cancer however treatment options for a patient in whom androgen ablation fails are limited Docetaxel and paclitaxel taxanes that are cell cycle specific play a major role in advanced hormone-refractory prostate cancer treatment In preclinical studies Xyotax a conjugate of paclitaxel with enhanced permeability and retention in tumor tissue has an improved therapeutic profile with both decreased systemic drug-related toxicities and enhanced efficacy Xyotax as a single agent has been studied in a broad variety of syngeneic and xenogeneic tumor models Recognizing that taxanes are active in prostate cancer and preclinical data reports activity with Xyotax in docetaxel and paclitaxel resistant cell lines there is significant rationale to develop this agent in prostate cancer Thus a phase II study is needed to evaluate the antitumor activity in two subsets of hormone refractory prostate cancer patients those with no prior systemic and those with one prior systemic therapy
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| PCa-X-02 | OTHER | Principal Investigator | None |