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A Randomized, Double Blinded, Multi-Center Study 2 Study to Estimate the Efficacy and Evaluate the Safety and Tolerability of Sorafenib in Combination with AMG 386 or Placebo in Subjects with Metastat...

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Reference: EUCTR2007-000147-98

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

Woman and Man

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Extract

To estimate the clinical benefit as measured by progression free survival (PFS) of subjects receiving AMG 386 (either 3mg/kg or 10mg/kg IV QW) in combination with sorafenib (400mg PO BID) compared to subjects receiving sorafenib (400mg PO BID) plus placebo.

Inclusion criteria

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

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