Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00050440
Status:
COMPLETED
Last Update Posted:
2013-01-08
First Post:
2002-12-09
Brief Title:
Phase 2 Study of ET-743 Trabectedin in Patients With Persistent or Recurrent Endometrial Carcinoma
Sponsor:
Johnson Johnson Pharmaceutical Research Development LLC
Organization:
Johnson Johnson Pharmaceutical Research Development LLC
Study Overview
Official Title:
A Phase 2 Study of ET-743 as Second-Line Therapy in Subjects With Persistent or Recurrent Endometrial Carcinoma
Status:
COMPLETED
Status Verified Date:
2013-01
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 is to test the safety and effectiveness of an investigational chemotherapy agent in patients with persistent or recurrent endometrial cancer
Detailed Description:
Patients will be enrolled in the study after all study-specific entry criteria are met and informed consent is obtained Patients will be required to attend regular clinic visits to receive study medication and have their status monitored They will also be required to have radiologic tumor assessments performed at multiple times throughout the study A detailed explanation can be provided by the Investigator conducting this study Trabectedin 13 mgm2 will be given every 21 days to patients intravenously iv over a 3-hour period via a central venous catheter referred to as a central line which is a tube ie catheter placed into a large vein that is used to administer medications Dexamethasone 4 mg will be given orally po the day before trabectedin and dexamethasone 20 mg will be given iv 30 minutes before trabectedin Dexamethasone 4 mg po will be given for 2 days following trabectedin administration
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 |
|---|---|---|---|
| ET743-USA-1 | OTHER | Johnson Johnson Pharmaceutical Research Development LLC | None |