A Randomized Phase 3, Multicenter, Open-Label Study Comparing TH-302 in Combination With Doxorubicin vs. Doxorubicin Alone in Subjects With Locally Advanced Unresectable or Metastatic Soft Tissue Sarcoma
The purpose of this study is to determine whether TH-302 in combination with Doxorubicin is safe and effective in the treatment of Locally Advanced Unresectable or Metastatic Soft Tissue Sarcoma.
Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.
- drug : Doxorubicin
- drug : TH-302 in Combination with Doxorubicin
Phase: Phase 3
Ages Eligible For Study:
- Male or female ? 15 years of age - Ability to understand the purposes and risks of the study and has signed or, if appropriate, the subject's parent or legal guardian has signed a written informed consent form approved by the investigator's IRB/Ethics Committee - Pathologically confirmed diagnosis of soft tissue sarcoma of the following histopathologic types: - Synovial sarcoma - High grade fibrosarcoma - Undifferentiated sarcoma; sarcoma not otherwise specified (NOS) - Liposarcoma - Leiomyosarcoma (excluding GIST) - Angiosarcoma (excluding Kaposi's sarcoma) - Malignant peripheral nerve sheath tumor - Pleomorphic Rhabdomyosarcoma - Myxofibrosarcoma - Epithelioid sarcoma - Undifferentiated pleomorphic sarcoma/malignant fibrous histiocytoma (MFH) (including pleomorphic, giant cell, myxoid and inflammatory forms) - Locally advanced unresectable or metastatic disease with no standard curative therapy available and for whom treatment with single agent doxorubicin is considered appropriate. - Recovered from reversible toxicities of prior therapy - Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 - Life expectancy of at least 3 months - Acceptable liver, renal, hematological and cardiac function - All women of childbearing potential must have a negative serum pregnancy test and all subjects must agree to use effective means of contraception