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

• Status: No longer available
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

Details

• Lead Sponsor: Sarcoma Alliance for Research through Collaboration
• Collaborator: Threshold Pharmaceuticals

Criteria

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.