A Study of LY573636-Sodium in the Treatment of Patients With Metastatic Soft Tissue Sarcoma
Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
Details and patient eligibility
About
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.
Full description
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).
Enrollment
Sex
Ages
Volunteers
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)
Trial design
Primary purpose
Allocation
Interventional model
Masking
101 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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