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

NCT02712567 | Unknown

• 1 other identifier: SARC021C
• Study Type: expanded_access
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Soft Tissue Sarcoma

Interventions

Th-302 DRUG

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

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sarcoma Alliance for Research through Collaboration: lead
• Threshold Pharmaceuticals: collaborator

MeSH Terms

Conditions

Sarcoma

Interventions

TH 302

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Study Design

• Study Type: expanded access
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2016
• First Posted: March 18, 2016
• Last Updated: October 13, 2016

Record last verified: 2016-10