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

Phase 1

Conditions: Patients with advanced or metastatic wild type CRAS, MET high, CRC who have progressed on a previous EGFR inibitor based regimen
MedDRA version: 14.1Level: HLGTClassification code 10017990Term: Malignant and unspecified neoplasms gastrointestinal NECSystem Organ Class: 10017947 - Gastrointestinal disorders
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2012-005578-79-IT

Lead Sponsor: ISTITUTO CLINICO HUMANITAS

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 40

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

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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