Everolimus-low-dose cyclophosphamide (gesloten voor inclusie)


Protocolnummer:

Ziekenhuizen:
Amphia Ziekenhuis Breda
Franciscus Gasthuis Rotterdam & Vlietland
Haga ziekenhuis
Isala Zwolle
Medisch Centrum Haaglanden
Medisch Centrum Leeuwarden
NKI / A.v.L ziekenhuis Amsterdam
Noordwest Ziekenhuisgroep Alkmaar & Den Helder
RadboudUMC Nijmegen
Spaarne Gasthuis Hoofddorp
St. Antonius ziekenhuis Nieuwegein
VU Medisch Centrum Amsterdam

Titel:
Phase 1-2 study of everolimus and low-dose oral cyclophophamide in patients with metastatic renal cell cancer.

Behandeling:
Phase 1 part: Everolimus 10mg once daily +cyclophosphamide according to dose (25,50,100 or 150mg) BID. Phase 2 part: dose level selected in phase 1.

Stadium:

Belangrijkste in/exclusiecriteria:
In: Patients with mRCC with progressive disease, prior therapy with cytokines and/or VEGF-ligand inhibitors is permitted, Karnofsky performance score of > or = 70%, adequate renal and hepatic function, life expectancy of at least 12 weeks. Ex: Chemo, immuno or radiotherapy within 4 weeks prior to visit 1, HIV-positive, active bleeding diathesis or on oral anti-vitamin K medication, untreated CNC metastasis, active infections, prior therapy with mTOR inhibitors, uncontrolled diabetes.



Contactpersoon:
C.M. Huijts - VU Medical Center, Amsterdam

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