Trial Information

Summary: A Phase 1b/2 Study of AMG 655 in Combination with Doxorubicin for the First-Line Treatment of Locally Advanced or Metastatic, Unresectable Soft Tissue Sarcoma

You have been asked to participate in this research study because you have been diagnosed with soft tissue sarcoma (STS). This research study will be conducted in two parts. The purpose of Part 1 is to determine the highest possible dose of the investigational drug AMG 655 that can be given in combination with doxorubicin (a chemotherapy drug commonly used to treat soft tissue sarcoma) before unmanageable side effects are seen. The purpose of Part 2 is to evaluate the side effects and effectiveness of AMG 655 (at the dose determined in Part 1) plus doxorubicin as compared to doxorubicin plus a placebo (an IV solution that looks like the study drug, but has no active medication). Researchers will also be looking at the effect of treatment on progression-free survival (survival without worsening of disease), how many people respond to treatment, how much treatment is needed before response is seen, how long the response lasts, and safety of the two treatments. Blood samples will be studied to see if subjects develop antibodies to the treatment and to study the levels of AMG 655 that stay in the body over time. Tumor tissue and blood samples will be collected and studied for biomarkers (biological characteristics) that may show which STS cancers are most likely to respond to treatment with AMG 655. The second part of this study will also look at the quality of life of subjects receiving treatment on this study. Your treatment on this study is expected to last for as long as your cancer is not growing and you are not having unmanageable side effects. After your treatment on this study is over, your medical condition will continue to be followed indefinitely.

Patient Inclusion/Exclusion Criteria:

- See http://clinicaltrials.coh.org for additional information.

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Trial listings updated: September 2, 2008 at 2:16:12 PM