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An early phase trial studying how well E7080 works in treating patients with advanced kidney cancer which has spread to other parts of the body. The first part of the trial will study the combination ...

Mise à jour : Il y a 4 ans
Référence : EUCTR2010-019484-10

An early phase trial studying how well E7080 works in treating patients with advanced kidney cancer which has spread to other parts of the body. The first part of the trial will study the combination of E7080 and everolimus. The second part will compare the treatments when given alone and when given in combination. The trial is taking place worldwide, patients know if they are receiving the study drug alone, in combination with everolimus or if they are recieving everolimus alone

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Extrait

Phase Ib: To determine the dose limiting toxicities and maximally tolerated dose and establish the recommended phase 2 (RP2) dose for E7080 incombination with everolimus in subjects with unresectable advanced or metastatic renal cell carcinoma (RCC). Phase 2: To compare the progression free survival of 1) E7080 in combination with everolimus at the RP2 dose once daily (Arm A) and 2) single agent E7080 24 mg once daily (Arm B) to single agent everolimus 10 mg once daily (Arm C) in subjects with unresectable advanced or metastatic RCC and disease progression following one prior VEGF targeted treatment.

Critère d'inclusion

  • Unresectable Advanced or Metastatic Renal Cell Carcinoma

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