Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00210665
Status:
NO_LONGER_AVAILABLE
Last Update Posted:
2017-10-10
First Post:
2005-09-13
Brief Title:
A Study to Provide Access to Trabectedin in Participants With Locally Advanced or Metastatic Soft Tissue Sarcoma Who Have Persistent or Recurrent Disease and Who Are Not Expected to Benefit From Currently Available Standard of Care Treatment
Sponsor:
Janssen Research Development LLC
Organization:
Janssen Research Development LLC
Study Overview
Official Title:
A Multicenter Open-Label Single-Arm Study of YONDELIS Trabectedin for Subjects With Locally Advanced or Metastatic Soft Tissue Sarcoma Who Have Relapsed or Are Refractory to Standard of Care Treatment
Status:
NO_LONGER_AVAILABLE
Status Verified Date:
2017-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to facilitate access to trabectedin for eligible previously treated patients with soft tissue sarcoma STS who cannot be expected to benefit from currently available therapeutic options but who may benefit from treatment with trabectedin The safety profile of trabectedin will be evaluated to further assess the potential risks of trabectedin treatment
Detailed Description:
This is a multicenter open-label all people know the identity of the intervention single-arm study It will consist of 2 Phases a Screening Phase up to 21 days before the first dose administration and Treatment Phase for patients meeting the continuation criteria During the Treatment Phase patients will receive a dose of 15 mgm2 trabectedin intravenous formulation administered as a 24-hour infusion on Day 1 of each suggested 21-day treatment cycle All patients will receive 20 mg dexamethasone or corticosteroid equivalent to dexamethasone Number of cycles is not specified for this study Patients may continue to receive treatment as long as they obtain an overall clinical benefit ie until there is clear evidence of disease progression or unacceptable toxicity as judged by the investigator Trabectedin is the first of a new class of antitumor agents Previous studies with trabectedin in patients who had been previously treated for soft tissue sarcoma have suggested that treatment with trabectedin resulted in tumor shrinkage disease stabilization and improved survival rates However hematologic toxicity hepatic toxicity and renal impairment were also observed in these patients The safety profile of trabectedin will be evaluated to further assess the potential risks of trabectedin treatment in patients previously treated for soft tissue sarcoma who are not expected to benefit from currently available therapeutic options for treatment of soft tissue sarcoma Safety will be monitored throughout the study
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 |
|---|---|---|---|
| ET743SAR3002 | OTHER | Janssen Research Development LLC | None |