Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2026-01-08 @ 11:54 AM
Study NCT ID:
NCT02712567
Status:
NO_LONGER_AVAILABLE
Last Update Posted:
2016-10-13
First Post:
2016-03-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SARC021C: A Continuation Study of TH-CR-406/SARC021
Sponsor:
Sarcoma Alliance for Research through Collaboration
Organization:
Study Overview
Official Title:
A Continuation Study of TH-CR-406/SARC021 for the Remaining Subjects Enrolled in TH-CR-406/SARC021 in the US
Status:
NO_LONGER_AVAILABLE
Status Verified Date:
2016-10
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:
SARC021C is a nonrandomized, open-label, multicenter, continuation study designed to provide access to TH-302 for patients currently receiving and benefiting from single agent TH-302 therapy as part of the Phase III TH-CR-406/SARC021 study.
Detailed Description:
The goal of this study is to provide continuation therapy with TH-302 to patients with soft tissue sarcomas who obtained response or stabilization of disease with prior treatment on TH-CR-406/SARC021 protocol. After written informed consent has been obtained and eligibility has been established, patients will receive the study drug as part of the continuation study. Patients will receive treatment on study as long as they have clinical benefit and do not experience unacceptable toxicity.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: