Ignite Creation Date:
2024-05-05 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00147212
Status:
COMPLETED
Last Update Posted:
2013-01-18
First Post:
2005-09-02
Brief Title:
ET 743 Yondelis in Men With Advanced Prostate Cancer
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
A Phase II Study of Three Hour Weekly Infusion of ET 743 Yondelis in Men With Advanced Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2012-12
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 main purpose of this study is to find out what effects good or bad trabectedin ET743 has on men with advanced prostate carcinoma
Detailed Description:
Treatment with trabectedin will be given once a week for three consecutive weeks with one week of no treatment This four week period constitutes one cycle
Trabectedin is given as an infusion through a central venous catheter and is administered over 3 hours
On day 1 of each cycle a history physical exam and blood tests will be performed and trabectedin will be administered
On day 8 and day 15 of each cycle blood work will be performed and trabectedin will be administered
Patients will continue to receive trabectedin as long as there is no disease progression or unacceptable side effects
Scans CT MRI or bone or x-rays may be done while the patient is on the trial at the discretion of the physician
Trabectedin is given as an infusion through a central venous catheter and is administered over 3 hours
On day 1 of each cycle a history physical exam and blood tests will be performed and trabectedin will be administered
On day 8 and day 15 of each cycle blood work will be performed and trabectedin will be administered
Patients will continue to receive trabectedin as long as there is no disease progression or unacceptable side effects
Scans CT MRI or bone or x-rays may be done while the patient is on the trial at the discretion of the physician
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