E7080-G000-218


Protocolnummer:
NL60657.028.17

Ziekenhuizen:
Franciscus Gasthuis Rotterdam & Vlietland
Haaglanden Medisch Centrum
Haga ziekenhuis
Leids Universitair Medisch Centrum
Maastricht UMC+

Titel:

A Randomized, Double-blind, Phase 2 Trial to Assess Safety and Efficacy of Lenvatinib at Two Different Starting Doses (18 mg vs. 14 mg QD) in Combination with Everolimus (5 mg QD) in Renal Cell Carcinoma Following One Prior VEGF-Targeted Treatment




Behandeling:
Assessment of Safety and Efficacy of Lenvatinib at Two Different Starting Doses (18 mg vs. 14 mg QD) in Combination with Everolimus (5 mg QD) in Renal Cell Carcinoma

Stadium:

Belangrijkste in/exclusiecriteria:

Inclusion:

  • Histological or cytological confirmation of predominant clear cell RCC
  • One prior disease progression episode on or after VEGF-targeted treatment
  • At least 1 measurable target lesion according to RECIST 1.1
  • Karnofsky Performance Status (KPS) of ≥70

Exclusion:

  • More than 1 prior VEGF-targeted treatment for advanced RCC
  • Active malignancy
  • Fasting total cholesterol ˃300 mg/dL (or ˃7.75 mmol/L) and/or fasting triglycerides level ˃2.5 x ULN
  • Active infection (any infection requiring systemic treatment).

Contactpersoon:

Alle niercelcarcinoom trials