Phase 1/1b Study of Rilotumumab in Japanese Subjects With Advanced Solid Tumors or Advanced or Metastatic Gastric or GEJ

PHASE1CompletedINTERVENTIONAL
Enrollment

21

Participants

Timeline

Start Date

November 30, 2012

Primary Completion Date

August 31, 2013

Study Completion Date

March 31, 2015

Conditions
Part 1- Advanced Solid TumorsPart 2- Advanced or Metastatic Gastric CancerPart 2- Advanced or Metastatic GEJ
Interventions
DRUG

Rilotumumab

Rilotumumab is a fully human monoclonal antibody immunoglobulin G, type 2 (IgG2) against human hepatocyte growth factor/scatter (HGF/SF) that blocks binding of HGF/SF to its receptor MET, inhibiting HGF/MET-driven activities in cells.

DRUG

Rilotumumab

Drug: Rilotumumab Rilotumumab is a fully human monoclonal antibody immunoglobulin G, type 2 (IgG2) against human hepatocyte growth factor/scatter (HGF/SF) that blocks binding of HGF/SF to its receptor MET, inhibiting HGF/MET-driven activities in cells. Drug: Cisplatin A platinum containing chemo-therapy compound that reacts in vivo, binding to and causing crosslinking of DNA, which ultimately triggers apoptosis (programmed cell death). Drug: Capecitabine A chemo-therapy prodrug, that is enzymatically converted to 5-fluorouracil in the tumor, where it inhibits DNA synthesis and slows growth of tumor tissue.

Trial Locations (7)

464-8681

Research Site, Nagoya

277-8577

Research Site, Kashiwa-shi

791-0280

Research Site, Matsuyama

060-8648

Research Site, Sapporo

216-8511

Research Site, Kawasaki-shi

362-0806

Research Site, Kitaadachi-gun

411-8777

Research Site, Suntou-gun

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Amgen

INDUSTRY