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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...

Mise à jour : Il y a 4 ans
Référence : 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

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Extrait

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.

Critère d'inclusion

  • 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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