Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2026-01-08 @ 11:54 AM
Study NCT ID:
NCT02712567
Status:
NO_LONGER_AVAILABLE
Last Update Posted:
2016-10-13
First Post:
2016-03-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SARC021C: A Continuation Study of TH-CR-406/SARC021
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012509', 'term': 'Sarcoma'}], 'ancestors': [{'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C552526', 'term': 'TH 302'}]}}, 'protocolSection': {'designModule': {'studyType': 'EXPANDED_ACCESS', 'nPtrsToThisExpAccNctId': 1}, 'statusModule': {'overallStatus': 'NO_LONGER_AVAILABLE', 'statusVerifiedDate': '2016-10', 'lastUpdateSubmitDate': '2016-10-12', 'studyFirstSubmitDate': '2016-03-09', 'studyFirstSubmitQcDate': '2016-03-14', 'lastUpdatePostDateStruct': {'date': '2016-10-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-03-18', 'type': 'ESTIMATED'}}, 'conditionsModule': {'conditions': ['Soft Tissue Sarcoma']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'eligibilityCriteria': "Inclusion Criteria:\n\n* 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.\n* Previously enrolled on the TH-CR-406/SARC021 protocol and benefiting from treatment.\n* Study investigator deems continued participation is appropriate based on overall health of the patient.\n\nExclusion Criteria:\n\n* Any of the criteria for study discontinuation are met.\n* 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.\n* Unwillingness or inability to comply with the study protocol for any reason."}, 'identificationModule': {'nctId': 'NCT02712567', 'briefTitle': 'SARC021C: A Continuation Study of TH-CR-406/SARC021', 'organization': {'class': 'OTHER', 'fullName': 'Sarcoma Alliance for Research through Collaboration'}, 'officialTitle': 'A Continuation Study of TH-CR-406/SARC021 for the Remaining Subjects Enrolled in TH-CR-406/SARC021 in the US', 'orgStudyIdInfo': {'id': 'SARC021C'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Th-302', 'type': 'DRUG', 'description': '300 mg/m2 IV on Days 1 and 8 of a 21-day cycle.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sarcoma Alliance for Research through Collaboration', 'class': 'OTHER'}, 'collaborators': [{'name': 'Threshold Pharmaceuticals', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}