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No Longer AvailableNCT02712567

SARC021C: A Continuation Study of TH-CR-406/SARC021

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
Phase
Study type
Expanded Access
Enrollment
Sponsor
Sarcoma Alliance for Research through Collaboration · Academic / Other
Sex
All
Age
Healthy volunteers

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.

Conditions

Interventions

TypeNameDescription
DRUGTh-302300 mg/m2 IV on Days 1 and 8 of a 21-day cycle.

Timeline

First posted
2016-03-18
Last updated
2016-10-13

Source: ClinicalTrials.gov record NCT02712567. Inclusion in this directory is not an endorsement.

SARC021C: A Continuation Study of TH-CR-406/SARC021 (NCT02712567) · Clinical Trials Directory