A Study of LY573636-Sodium in the Treatment of Patients With Metastatic Soft Tissue Sarcoma

A Phase 2 Study of LY573636-Sodium Administered as Second-line or Third-line Treatment in Patients With Unresectable or Metastatic Soft Tissue Sarcoma

The primary purpose of the study is to estimate the time from the first dose of LY573636-sodium (hereafter referred to as LY573636) to the date your physician determines that your disease has progressed or worsened.

Patients will receive a 2-hour intravenous infusion of study drug (LY573636) once every 21 days or 28 days depending on their target dose. Radiological imaging scans will be performed before the first dose of study drug and then after every other treatment. Patients will be assessed for clinical progression at every visit and for response approximately every 42 days or 56 days (every other cycle).

Inclusion Criteria:

• Diagnosis of soft tissue sarcoma that is unresectable or metastatic
• Have received one or two (but no more than two) prior treatment regimens for metastatic soft tissue sarcoma, one of which must have included doxorubicin (adriamycin).
• Must have stopped all previous treatments for cancer, including chemotherapy, radiation therapy or other investigational treatments for cancer for at least 30 days

Exclusion Criteria:

• Participants with primary bone sarcoma (for example osteosarcoma, Ewing's sarcoma, chondrosarcoma), gastrointestinal stromal tumor (GIST) and Kaposi's sarcoma
• Serious pre-existing medical problems (as determined by your doctor)
• Have received more than two previous systemic treatment regimens for unresectable or metastatic soft tissue sarcoma
• Have a second primary cancer (unless cancer-free for more than 2 years)
• Active treatment with Warfarin (Coumadin)