Trial Information

Summary: A Pivotal Trial to Determine the Efficacy and Safety of AP23573 When Administered as Maintenance Therapy to Patients with Metastatic Soft Tissue or Bone Sarcomas

You have/your child has been asked to participate in this research study because you have/your child has sarcoma (cancer of the supportive tissue, such as bone, cartilage, fat or muscle) and have recently completed chemotherapy without any worsening of the cancer. In addition, you/your child had treatment with the first, second, or third line of therapy. The purpose of this research study is to see whether or not subjects who receive the investigational oral medication AP23573 have a longer period of disease stabilization before their disease worsens and survive longer as compared to subjects who do not receive AP23573. Additional purposes of this research study are to evaluate the side effects and effectiveness of AP23573 when compared to placebo. Blood samples and tumor tissue from a previous biopsy will be obtained to identify biological characteristics that may predict response to treatment with AP23573. Your/your child’s treatment on this study is expected to last for as long as you are/your child is not having unmanageable side effects and you/your child’s tumor is not growing. After your/your child’s treatment on this study is over, your/your child’s medical condition will continue to be followed for up to five years.

Patient Inclusion/Exclusion Criteria:

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

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Trial listings updated: December 1, 2008 at 3:15:49 PM