A Phase III Study of Doxorubicin Alone or in Combination with TH-302 in Patients with Locally Advanced Inoperable or Metastatic Soft-Tissue Sarcoma

Protocol
11-203
Full Title
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
Phase
III
Purpose

TH-302 is an investigational drug that only becomes active in certain parts of the body — in this case, in cells with low oxygen levels. Cancer cells that are low in oxygen often do not succumb to standard chemotherapy or radiation treatment. TH-302 may be able to kill cancer cells that are low in oxygen without causing too much damage to normal cells with normal oxygen levels.

Doxorubicin is a standard chemotherapy drug used to treat soft-tissue sarcoma. In this study, researchers are comparing doxorubicin plus TH-302 with doxorubicin alone in patients with locally advanced inoperable or metastatic soft-tissue sarcoma. Patients will be randomly assigned to receive doxorubicin plus TH-302 or doxorubicin alone.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have locally advanced inoperable or metastatic soft-tissue sarcoma.
  • Patients may have had prior therapy, but no systemic therapy for advanced disease.
  • At least 4 weeks must have passed since completion of prior therapy and entry into the study.
  • Patients who previously have had ifosfamide, cyclophosphamide, or anthracyclines may not participate.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • Patients must be age 15 or older.

For more information about this study and to inquire about eligibility, please contact Dr. William Tap at 646-888-4163.

Disease(s)
Sarcomas
Sarcomas: Soft Tissue Sarcoma
Locations
Related Diseases