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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
Phases
Unknown
Study type
Expanded Access
Source
ClinicalTrials.gov
Registry ID
NCT02712567
Enrollment
Unknown
Registered
2016-03-18
Start date
Unknown
Completion date
Unknown
Last updated
2016-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Soft Tissue Sarcoma

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.

Interventions

DRUGTh-302

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

Sponsors

Threshold Pharmaceuticals
CollaboratorINDUSTRY
Sarcoma Alliance for Research through Collaboration
Lead SponsorOTHER

Eligibility

Sex/Gender
ALL

Inclusion criteria

* Ability to understand the purposes and risks of the study and has signed a written informed consent form approved by the investigator's IRB/Ethics Committee. * Previously enrolled on the TH-CR-406/SARC021 protocol and benefiting from treatment. * Study investigator deems continued participation is appropriate based on overall health of the patient.

Exclusion criteria

* Any of the criteria for study discontinuation are met. * Concomitant disease or condition that could interfere with the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study. * Unwillingness or inability to comply with the study protocol for any reason.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026