(TH-CR-406/SARC021) 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

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Title (TH-CR-406/SARC021) 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
Contact KH
Principal Investigator Nikhil Khushalani, MD
Study Number 208111
Phase3
Summary

This Phase 3, multi-center, randomized, open label study is designed to evaluate the efficacy and safety of TH-302 plus doxorubicin as compared with doxorubicin alone.  TH-302 is designed to target the hypoxic regions of tumors which are generally located distant from tumor vessels.  Doxorubicin has poor tissue penetration and targets the regions of tumors that are located in proximity to the tumor vessels.  Combining doxorubicin with TH-302 may enable the targeting of both the normoxic and hypoxic regions of soft tissue sarcoma.

Eligibility

Male or female >= 18 years of age

Locally advanced unresectable or metastatic disease with no standard curative therapy available and for whom treatment with single agent doxorubicin is considered appropriate.

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 peripeheral nerve sheath tumor
  • Pleomorphic Rhabdomyosarcoma
  • Myxofibrosarcoma
  • Epithelioid sarcoma
  • Undifferentiated pleomorphic sarcoma/malignant fibrous histiocytoma (MFH) (including pleomorphic, giant cell, myxoid and inflammatory forms)

Life expectancy of at least 3 months

EXCLUSION:

Prior systemic therapy for advanced or metastatic disease (neoadjuvant therapy followed by surgical resection and adjuvant therapy permitted)

Current use of drugs with known cardiotoxicity or known interactions with doxorubicin

Low grade tumors according to standard grading systems

 

For more information about the clinical study go to Clinicaltrial.Gov