Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00060944
Status:
COMPLETED
Last Update Posted:
2014-09-08
First Post:
2003-05-16
Brief Title:
A Study to Assess Treatment With 2 Different Dosing Schedules of Trabectidin Administered to Patients With Advanced Cancer
Sponsor:
Johnson Johnson Pharmaceutical Research Development LLC
Organization:
Johnson Johnson Pharmaceutical Research Development LLC
Study Overview
Official Title:
A Randomized Multicenter Open-label Study of Yondelis ET-743 Ecteinascidin Administered by 2 Different Schedules Weekly for 3 of 4 Weeks vs q3 Weeks in Subjects With Locally Advanced or Metastatic Liposarcoma or Leiomyosarcoma Following Treatment With an Anthracycline and Ifosfamide
Status:
COMPLETED
Status Verified Date:
2014-08
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 types of advanced cancer referred to as liposarcoma or leiomyosarcoma
Detailed Description:
This is an open-label patients will know the names of the study drugs they receive randomized patients will be assigned by chance to receive 1 of 2 treatment schedules with trabectidin study designed to examine the the survival safety and pharmacokinetics blood levels trabectedin when administered to patients with 2 types of cancer Liposarcoma or Leiomyosarcoma who have received treatment with other anti-cancer therapy Anthracycline andor Ifosfamide Trabectedin also referred to as Yondelis is a drug being developed to treat patients with cancer Yondelis will be administered intravenously iv via a central catheter tube into a central vein once a week 058 mgm2 as a 3-hour infusion on Days 1 8 and 15 of each 28-day treatment cycle or once every 3 weeks 15 mgm2 administered as a 24-hour infusion on Day 1 of every 21-day treatment cycle until disease progression Patients in each arm will be pretreated with 20 mg of dexamethasone iv 30 minutes prior to each infusion
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-STS-201 | OTHER | Johnson Johnson Pharmaceutical Research and Development LLC | None |