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

Soft Tissue Sarcoma Clinical Trial

Official title:

A Continuation Study of TH-CR-406/SARC021 for the Remaining Subjects Enrolled in TH-CR-406/SARC021 in the US

Clinical Trial Details — Status: No longer available

Administrative data

• NCT number: NCT02712567
• Other study ID #: SARC021C
• Status: No longer available
• Phase: N/A
• First received: March 9, 2016
• Last updated: October 12, 2016

Study information

• Verified date: October 2016
• Source: Sarcoma Alliance for Research through Collaboration
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Expanded Access

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: No longer available
• Enrollment: 0
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

N/A

Related Conditions & MeSH terms

• Sarcoma
• Soft Tissue Sarcoma

Intervention

Drug:
• Th-302
300 mg/m2 IV on Days 1 and 8 of a 21-day cycle.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Sarcoma Alliance for Research through Collaboration	Threshold Pharmaceuticals