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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02712567
Expanded Access Status : No longer available
First Posted : March 18, 2016
Last Update Posted : October 13, 2016
Sponsor:
Collaborator:
Threshold Pharmaceuticals
Information provided by (Responsible Party):
Sarcoma Alliance for Research through Collaboration

Study Description
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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.

Condition or disease Intervention/treatment
Soft Tissue Sarcoma Drug: Th-302

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.
Study Design
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Study Type : Expanded Access
  See clinical trials of the intervention/treatment in this expanded access record.
Official Title: A Continuation Study of TH-CR-406/SARC021 for the Remaining Subjects Enrolled in TH-CR-406/SARC021 in the US

Resource links provided by the National Library of Medicine


Interventions
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Intervention Details:
  • Drug: Th-302
    300 mg/m2 IV on Days 1 and 8 of a 21-day cycle.
Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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.
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Responsible Party: Sarcoma Alliance for Research through Collaboration
ClinicalTrials.gov Identifier: NCT02712567    
Other Study ID Numbers: SARC021C
First Posted: March 18, 2016    Key Record Dates
Last Update Posted: October 13, 2016
Last Verified: October 2016
Additional relevant MeSH terms:
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Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms