IRB #

IRB00008311

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

Principal Investigator

Christopher Ryan

Study Purpose

The purpose of the study is to compare the effects, good and bad, of the study drug (TH-302) in combination with doxorubicin with doxorubicin alone on you and your soft tissue sarcoma.

Medical Condition(s)

Locally advanced unresectable or metastatic soft tissue sarcoma

Eligibility Criteria

Age 15 or over diagnosed with locally advanced unresectable or metastatic soft tissue sarcoma with no prior systemic treatment. Blood work, imaging, and heart scans will be performed to determine eligibility upon consent.

Age Range

15 - 120

Healthy Volunteers Needed

No

Duration of Participation

Treatment will last for approximately 5 months. Follow up will last for up to 36 months post first dose of study treatment.

Minors Included

No

Contact

David Boody-Alter
503-418-9655
boodyalt@ohsu.edu

Sponsor

Threshold Pharmaceuticals

Recruitment End

06/01/2014

Compensation Provided

No