Back to resultsSARC021C: A Continuation Study of TH-CR-406/SARC021
Primary Purpose
Soft Tissue Sarcoma
Status
No longer available
Phase
Locations
Study Type
Expanded Access
Intervention
Th-302
Sponsored by
About this trial
This is an expanded access trial for Soft Tissue Sarcoma
Eligibility 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.
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT02712567
First Posted
March 9, 2016
Last Updated
October 12, 2016
Sponsor
Sarcoma Alliance for Research through Collaboration
Collaborators
Threshold Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT02712567
Brief Title
SARC021C: A Continuation Study of TH-CR-406/SARC021
Official Title
A Continuation Study of TH-CR-406/SARC021 for the Remaining Subjects Enrolled in TH-CR-406/SARC021 in the US
Study Type
Expanded Access
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
No longer available
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sarcoma Alliance for Research through Collaboration
Collaborators
Threshold Pharmaceuticals
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Soft Tissue Sarcoma
7. Study Design
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Th-302
Intervention Description
300 mg/m2 IV on Days 1 and 8 of a 21-day cycle.
10. Eligibility
Sex
All
Eligibility 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.
12. IPD Sharing Statement
Learn more about this trial
SARC021C: A Continuation Study of TH-CR-406/SARC021
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