NCI #8986) A Randomized, Double-Blind, Placebo-Controlled Phase II study of ARQ 197 (tivantinib) in Men with Asymptomatic or Minimally Symptomatic Metastatic Castrate Resistant Prostate Cancer.

Title NCI #8986) A Randomized, Double-Blind, Placebo-Controlled Phase II study of ARQ 197 (tivantinib) in Men with Asymptomatic or Minimally Symptomatic Metastatic Castrate Resistant Prostate Cancer.
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Principal Investigator Roberto Pili, MD
Study Number 208411
Phase2
Summary Patients will be randomized in a 2:1 ratio to receive either ARQ 197 or placebo.  Treatment will continue for 3 cycles or until disease progression determined by the Prostate Cancer Clinical Trials Working Group (PGWG2).  At the time of disease progression the blind will be broken and patients on the placebo arm will be given the choice to receive ARQ 197.  Each cycle is 28 days.
Eligibility See Clinical trials.gov listing for eligibility criteria.