Clinical Trials Logo

Clinical Trial Details — Status: No longer available

Administrative data

NCT number NCT02712567
Other study ID # SARC021C
Secondary ID
Status No longer available
Phase N/A
First received March 9, 2016
Last updated October 12, 2016

Study information

Verified date October 2016
Source Sarcoma Alliance for Research through Collaboration
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Expanded Access

Clinical Trial 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.


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.


Recruitment information / eligibility

Status No longer available
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender Both
Age group N/A and older
Eligibility 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.

Study Design

N/A


Related Conditions & MeSH terms


Intervention

Drug:
Th-302
300 mg/m2 IV on Days 1 and 8 of a 21-day cycle.

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Sarcoma Alliance for Research through Collaboration Threshold Pharmaceuticals
See also
  Status Clinical Trial Phase
Recruiting NCT02910895 - A Platform of Patient Derived Xenografts (PDX) and 2D/3D Cell Cultures of Soft Tissue Sarcomas (STS) N/A
Recruiting NCT05621668 - A First-In-Human Phase 1 Trial of T-Cell Membrane-Anchored Tumor Targeted Il12 (Attil12)- T-Cell Therapy in Subjects With Advanced/Metastatic Soft Tissue and Bone Sarcoma Phase 1
Active, not recruiting NCT04032964 - Dose Finding Study of L19TNF and Doxorubicin in Patients With STS Phase 1
Active, not recruiting NCT04577014 - Retifanlimab (Anti-PD-1 Antibody) With Gemcitabine and Docetaxel in Patients With Advanced Soft Tissue Sarcoma Phase 1/Phase 2
Completed NCT01650077 - Therapeutic Response of Patients With Soft Tissue Sarcoma According to CHOI Criteria
Withdrawn NCT04906876 - A Phase 2 Study of 9-ING-41Combined With Chemotherapy in Adolescents and Adults With Advanced Sarcomas Phase 2
Terminated NCT02890368 - Trial of Intratumoral Injections of TTI-621 in Subjects With Relapsed and Refractory Solid Tumors and Mycosis Fungoides Phase 1
Terminated NCT02628535 - Safety Study of MGD009 in B7-H3-expressing Tumors Phase 1
Completed NCT02204111 - Patient Directed Intervention to Improve the Quality of Life for Patients With Soft Tissue Sarcoma
Withdrawn NCT01663090 - Ferumoxytol-Enhanced MRI in Adult/Pedi Sarcomas N/A
Completed NCT01259375 - Amrubicin Chemotherapy as First Line in Metastatic or Unresectable Soft Tissue Sarcoma Phase 2
Completed NCT01440088 - A Trial of TH-302 in Combination With Doxorubicin Versus Doxorubicin Alone to Treat Patients With Locally Advanced Unresectable or Metastatic Soft Tissue Sarcoma Phase 3
Completed NCT01106872 - Bevacizumab, Chemotherapy and Valproic Acid in Advanced Sarcomas Phase 1
Recruiting NCT00753727 - Sunitinib and Radiation in Patients With Resectable Soft-tissue Sarcoma Phase 1/Phase 2
Terminated NCT00755261 - Phase II Study of Doxorubicin and Avastin® in Sarcoma. Phase 2
Completed NCT00580320 - Safety Study of Dacarbazine and Bortezomib in Melanoma and Soft Tissue Sarcoma Phase 1
Completed NCT00611078 - Environmental Pollutants and the Risk of Soft Tissue Sarcoma: A Pilot Study N/A
Completed NCT03452644 - US-Guided Biopsy in the Diagnosis of Musculoskeletal Soft-Tissue Tumors
Recruiting NCT05539677 - Biobank and Register of Patients With Agresive Tumors for Translational and Analytical Research
Terminated NCT03520959 - A Phase 3, Randomized, Double-blind, Placebo-controlled Study For Subjects With Locally-advanced Unresectable or Metastatic Synovial Sarcoma (V943-003, IMDZ-04-1702) Phase 3