Phase II Trial of Pimasertib Versus Dacarbazine in N-Ras Mutated Cutaneous Melanoma

PHASE2CompletedINTERVENTIONAL
Enrollment

194

Participants

Timeline

Start Date

December 5, 2012

Primary Completion Date

July 4, 2015

Study Completion Date

October 24, 2016

Conditions
N-Ras Mutated Locally Advanced or Metastasis Malignant Cutaneous Melanoma
Interventions
DRUG

Pimasertib

Subjects will receive pimasertib orally as monotherapy at a dose of 60 milligram (mg) twice daily continuously. Treatment will consist of repeated 21-day cycles which will continue until progression of the disease, unacceptable toxicity, withdrawal of informed consent, or death, whichever occurs first.

DRUG

Dacarbazine

Subjects will receive dacarbazine intravenously at dose of 1000 milligram per square meter (mg/m\^2) of body surface area every 3 weeks on Day 1 of each 21-days cycle until progression of the disease, unacceptable toxicity, withdrawal of informed consent, or death, whichever occurs first. Eligible subjects with documented tumor progression on dacarbazine will offer to switch to pimasertib treatment.

Trial Locations (101)

Unknown

Research Site, Birmingham

Research Site, Tucson

Research Site, San Francisco

Research Site, Miami Beach

Research Site, Orlando

Research Site, Maywood

Research Site, Indianapolis

Research Site, Boston

Please contact the US Medical Information in, Rockland

Research Site, St Louis

Research Site, Morristown

Research Site, New York

Research Site, Columbus

Research Site, Dallas

Research Site, Madison

Research Site, Adelaide, SA

Research Site, Albury/Wodonga

Research Site, Auchenflower

Research Site, Box Hill

Research Site, Greenslopes

Research Site, Herston

Research Site, Malvern

Research Site, North Sydney

Research Site, Prahran

Research Site, Wendouree

Research Site, Woodville South

Research site, Woolloongabba

Research Site, Brussels

Research Site, Edegem

Research Site, Bordeaux

Research Site, Brest

Research Site, Dijon

Research Site, Lille

Research Site, Lyon

Research Site, Marseille

Research Site, Montpellier

Research Site, Nantes

Research Site, Paris

Research Site, Pierre-Bénite

Research Site, Rennes

Research Site, Toulouse

Research Site, Villejuif

Research Site, Augsburg

Research Site, Berlin

Research Site, Bonn

Research Site, Buxtehude

Research Site, Cologne

Research site, Düsseldorf

Research Site, Erlangen

Research Site, Essen

Research Site, Frankfurt am Main

Research Site, Hamburg

Research Site, Hanover

Research Site, Kiel

Research Site, Leipzig

Research Site, Magdeburg

Research Site, Mainz

Research site, München

Research Site, Münster

Research Site, Plauen

Research Site, Tübingen

Research Site, Würzburg

Research Site, Jerusalem

Research Site, Ramat Gan

Research Site, Tel Aviv

Research Site, Bari

Research Site, Genova

Research Site, Meldola - FC

Research Site, Milan

Research Site, Napoli

Research Site, Padua

Research Site, Roma

Research Site, Siena

Research Site, Groningen

Research Site, Rotterdam

Research Site, Utrecht

Research Site, Christchurch

Research Site, Hamilton

Research Site, Palmerston North

Research Site, Tauranga

Research Site, Durban

Research Site, Johannesburg

Research Site, Pietermaritzburg

Research Site, Pretoria

Research Site, Badalona

Research Site, Barcelona

Research Site, L'Hospitalet de Llobregat

Research Site, Madrid

Research Site, Majadahonda

Research Site, Málaga

Research Site, Pamplona

Research Site, Seville

Research Site, Gothenburg

Research Site, Stockholm

Research Site, Basel

Research Site, Zurich

Research Site, Cambridge

Research Site, London

Research Site, Manchester

Research Site, Newcastle upon Tyne

Research Site, Southampton

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Merck KGaA, Darmstadt, Germany

INDUSTRY

lead

EMD Serono

INDUSTRY

NCT01693068 - Phase II Trial of Pimasertib Versus Dacarbazine in N-Ras Mutated Cutaneous Melanoma | Biotech Hunter | Biotech Hunter