Trial Information

Summary: A Randomized, Double Blinded, Multi-Center Phase 2 Study to Estimate the Efficacy and Evaluate the Safety and Tolerability of Sorafenib in Combiniation with AMG 386 or Placebo in Subjects with Metastatic Clear Cell Carcinoma of the Kidney

You have been asked to participate in this research study because you have advanced or metastatic (spread to other organs) cancer of the kidney(s). The purpose of this study is to compare the effectiveness of the investigational drug AMG 386 plus sorafenib to sorafenib plus placebo (drug that looks identical to AMG 386 but that contains no active drug) at slowing the progression of kidney cancer. The harmful effects of AMG 386 will also be studied. Information will be collected on subjects’ functional status (ability to carry out daily activities), symptoms, quality of life, changes in the size of the tumor and laboratory findings to help researchers evaluate the safety and effectiveness of AMG 386. A series of blood samples will be drawn for pharmacokinetic (PK) testing that shows how the body processes AMG 386 over time. Additional research tests will be done to increase understanding of kidney tumors and how they are affected by AMG 386. Your treatment on this study is expected to last for as long as your cancer is not growing and you are not having any unmanageable side effects. After your treatment is complete, your medical condition will be followed for up to 4 years after you are enrolled in this study.

Patient Inclusion/Exclusion Criteria:

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

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Trial listings updated: June 2, 2008 at 2:51:55 PM