Trial intelligence / Profile preview

Tivantinib (ARQ 197) in Relapsed or Refractory Germ Cell Tumors

NCT01055067Phase 2

Key facts

Status: Terminated
Start: Feb 2010
Primary completion: Nov 2011
Countries: 3
Sponsor: Daiichi Sankyo Co., Ltd.
Modality: Small Molecules

Drugs: tivantinib
Conditions: germ cell tumor (GCT)

Overview

Phase 2, open-label, single-arm trial of tivantinib in germ cell tumor (GCT), sponsored by Daiichi Sankyo Co., Ltd. Primary endpoint: Objective Response Rate. Started Feb 2010; status: terminated.

Design

1 arm

Study design: Non-randomizedOpen-label

Tivantinib (ARQ 197)
Experimental arm receiving Tivantinib

Endpoints

Primary

Objective Response Rateup to 1 year 9 months

Secondary

Progression-Free Survivalup to 1 year 9 months
Overall Survivalup to 1 year 9 months
Treatment-Emergent Adverse Eventsup to 30 days after last dose

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