Evalutation study treatment Tivantinib and Cetuximab in combination for patients with locally advanced or metastatic colonrectal cancer

A single-Arm Phase II Study of Tivantinib (ARQ 197) plus Cetuximab in EGFR inhibitor-resistant MET high subjects with locally advanced or metastatic colorectal cancer with wild-type KRAS

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-005578-79-IT

Enrollment

Registered

2012-12-21

Start date

2013-02-09

Completion date

Unknown

Last updated

2019-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with advanced or metastatic wild type CRAS, MET high, CRC who have progressed on a previous EGFR inibitor based regimen MedDRA version: 14.1 Level: HLGT Classification code 10017990 Term: Malignant and unspecified neoplasms gastrointestinal NEC System Organ Class: 10017947 - Gastrointestinal disorders

Interventions

Product Name: TIVANTINIB Product Code: NA Pharmaceutical Form: Tablet INN or Proposed INN: TIVANTINIB CAS Number: 1000873-98-2 Concentration unit: mg milligram(s) Concentration type: equal Concentrati

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: subjet with surgically unresectablelocally advanced or metastatic disease who have recive at least one prior line of systematic therapies for advanced or metastatic disease, radiological evidence, subjets must have radiologicaly documented disease progression before arrolment subjects must express the wild type form of gene KRAS fresh tumor biopsy tissue available for molecular sequencing and biomarker eor expression age = > 18 years Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 12 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 28

Exclusion criteria

Exclusion criteria: history of malignancy other then CRC unless there is an exception that the malignancy has been cured and no tumor- specific treatment for the malignancy has been administered within the 3 weeks prior to the initiation, history of cardiac diseade defined as class II-IV per NYHA classification, any condition that is unstable that could jeopardize the safety of the subject

Design outcomes

Primary

Measure	Time frame
Main Objective: to determine objective response rate (orr) of cetuximab plus tivantinib in patients with Kras wild type CRC that is resistant to EGFR antibody treatment and shows over expression of MET;Secondary Objective: to estimate progression-free survival (PFS) robability in the ITT population to estimate overall survival(OS)probability in the ITT population;Primary end point(s): ORR objective response rating;Timepoint(s) of evaluation of this end point: 4 cicles of therapy	—

Measure

Time frame

Main Objective: to determine objective response rate (orr) of cetuximab plus tivantinib in patients with Kras wild type CRC that is resistant to EGFR antibody treatment and shows over expression of MET;Secondary Objective: to estimate progression-free survival (PFS) robability in the ITT population to estimate overall survival(OS)probability in the ITT population;Primary end point(s): ORR objective response rating;Timepoint(s) of evaluation of this end point: 4 cicles of therapy

—

Secondary

Measure	Time frame
Secondary end point(s): to estimate proression free survival probability in the ITT population;Timepoint(s) of evaluation of this end point: 12 months	—

Countries

Italy

Contacts

Public Contactdirezione ricerca clinica

SOLARIS

regulatory@solaris-italy.com0276115147

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026