Columbus (MEK162 B2301)

Officieel gesloten - nog wel patiënten in behandeling

Amphia Ziekenhuis Breda
Erasmus Medisch Centrum Rotterdam
Isala Zwolle
Leids Universitair Medisch Centrum
Maxima Medisch Centrum Eindhoven
Medisch Centrum Leeuwarden
Medisch Spectrum Twente Enschede
RadboudUMC Nijmegen
Universitair Medisch Centrum Groningen
Universitair Medisch Centrum Utrecht
VU Medisch Centrum Amsterdam
Zuyderland Medisch Centrum Heerlen

Phase lll , randomized , 3-arm, open label, multicenter study of LGX818 plus MEK162 and LGX818 monotherapy compared with vemurafenib in patients with unresectable or metastatic BRAF V600 mutant melanoma.

LGX818 (300mg QD) or LGX818 (450mg QD) + MEK 162 (45mg BID) or vemurafenib (960mg BID)

Stadium irresectable IIIc/IV

Belangrijkste in/exclusiecriteria:
In: AJCC (stage lllB, lllC or lV), presence of BRAF V600E or V600K mutation, naive patients: prior adjuvant therapy is permitted, at least one measurable lesion, ECOG status of 0 or 1. Ex: active and non-stable brain lesions, Gilbert's syndrome, uncontrolled hypertension, history of leptomeningeal metastases, impaired gastrointestinal function.


Alle melanoom trials