drugset / Trial / NCT01892527

Study of Tivantinib (ARQ 197) Plus Cetuximab in EGFR Inhibitor-Resistant MET High Subjects

NCT01892527

Phase 2 Completed 43 enrolled Armando Santoro, MD
NaSingle-groupOpen-labelTreatment

Summary

This is a single-arm, Simon 2-stage, phase 2 clinical study conducted in subjects with advanced or metastatic colorectal cancer who have previously received ≥ 1 prior line of systemic therapies and are resistant to EGFR inhibitor (cetuximab or panitumumab). This trial will be conducted to determine objective response rate (ORR), progression-free survival (PFS) and overall-survival (OS) of cetuximab plus tivantinib in patients with wild-type KRAS CRC that is resistant to anti-EGFR antibody treatment (cetuximab or panitumumab) and shows overexpression of cMET.

Timeline

Start
2013-03
Primary completion
2016-05
Completion
2017-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Cetuximab Monoclonal antibody 500 mg/m2 Intravenous
Subject Tivantinib Small molecule 360 mg Oral

Indications