131
Participants
Start Date
January 26, 2010
Primary Completion Date
October 12, 2012
Study Completion Date
February 20, 2015
Tivantinib
ARQ 197 is supplied as a 120-mg capsule, administered twice daily at the dose determined in the Phase 1 portion of the study. Administered until disease progression, unacceptable toxicity or other discontinuation criteria is met.
Placebo
Placebo to match ARQ 197, administered twice daily. Administered until disease progression, unacceptable toxicity or other discontinuation criteria is met.
Cetuximab
Cetuximab 500 mg/ m\^2 intravenous infusion over 120 minutes at the first cycle, then over 60-minutes at subsequent cycles. Administered on Day 1 and Day 15 of each 28 day cycle. Administered until disease progression, unacceptable toxicity or other discontinuation criteria is met.
Irinotecan
60 minutes after cetuximab, Irinotecan 180 mg/m\^2 intravenous infusion over 30 - 90 minutes. Administered on Day 1 and Day 15 of each 28 day cycle. Administered until disease progression, unacceptable toxicity or other discontinuation criteria is met.
Lake Success
Marseille
Buffalo
Milan
Baltimore
Hagerstown
Treviglio
Leer
Columbia
Charleston
Orlando
Boynton Beach
Fort Myers
Reggio Emilia
Canton
Cincinnati
Lille
Centralia
Bayonne
Omaha
Mannheim
Metairie
Oklahoma City
Houston
Fort Collins
München
Encinitas
Riverside
Fountain Valley
Seattle
Moscow
Saint Petersburg
Kursk
Pyatigorsk
Nashville
Samara
Chelyabinsk
Beverly Hills
Norwich
Halle
Lead Sponsor
Daiichi Sankyo
INDUSTRY