Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00050414
Status:
COMPLETED
Last Update Posted:
2013-01-10
First Post:
2002-12-09
Brief Title:
A Study of Trabectedin in Patients With Advanced Ovarian Cancer
Sponsor:
Johnson Johnson Pharmaceutical Research Development LLC
Organization:
Johnson Johnson Pharmaceutical Research Development LLC
Study Overview
Official Title:
Phase 2 Study of Efficacy and Safety of Trabectedin in Subjects With Advanced Ovarian Cancer
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 study is to test the safety and effectiveness of an investigational chemotherapy agent in patients with advanced ovarian 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 Patients will also be required to have radiologic tumor assessments performed at multiple times throughout the study A detailed explanation can be provided by the study physician Investigator conducting this study Trabectedin at a starting dose of 058 mgm2 will be given to patients intravenously iv as a 3-hour infusion every week for 3 weeks on Days 1 8 and 15 of a 4 week cycle via a central venous catheter also referred to as a central line which is a tube ie catheter placed into a large vein All patients will receive dexamethasone 10 mg iv 30 minutes prior to each trabectedin infusion Patients may receive multiple cycles of trabectedin in the absence of disease progression
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-INT-11 | OTHER | Johnson Johnson Pharmaceutical Research Development LLC | None |