Randomized phase II study to evaluate the efficacy of second-line FOLFIRI + panitumumab in subjects with wild type RAS metastatic colorectal cancer who have received FOLFOX + panitumumab in first-line - BEYOND TRIA

Grupo Español Multidisciplinar en Cáncer Digestivo (GEMCAD0 sites85 target enrollmentApril 9, 2018

Overview

No summary available.

Registry

who.int

Start Date

April 9, 2018

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Grupo Español Multidisciplinar en Cáncer Digestivo (GEMCAD

•1\)Man or woman at least 18 years old
•2\)Capable of understand, sign and date an informed consent approved by an IEC
•3\)Histologically confirmed adenocarcinoma of the colon or rectum in subjects with metastatic disease
•4\)Having received a 1st line chemotherapy regimen for mCRC consisting of FOLFOX \+ panitumumab and having at least achieved stable disease ( i.e., CR, PR or SD)
•5\)Wild\-type RAS tumour status confirmed in liquid biopsies before starting second\-line treatment
•6\)At least one unidimensionally measurable lesion of at least 10 mm per RECIST criteria (version 1\.1\)
•7\)Subjects not candidates for metastasectomy
•8\)Tumour disease staging according to RECIST (version 1\.1\) by investigator up to 4 weeks prior to start of study treatment
•9\)Eastern Cooperative Oncology Group (ECOG) performance status \= 2
•10\)Adequate bone marrow function: neutrophils \=1\.5 x109/ L; platelets \=100 x109/L; haemoglobin \=9 g/dL

•1\)Diagnosis of progressive disease more than 3 months after the last panitumumab administration
•2\)First\-line PFS of less than 3 months
•3\)Subjects given less than 3 months (consecutive) of first\-line panitumumab
•4\)History of prior or concurrent central nervous system (CNS) metastases
•5\)History of another primary cancer, except: curatively treated in situ cervical cancer, or curatively resected non\-melanoma skin cancer, or other primary solid tumour curatively treated with no known active disease present and no treatment administered for \= 5 years before inclusion
•6\)Prior irinotecan therapy
•7\)Unresolved toxicities of a previous systemic treatment that, in the opinion of the investigator, cause the subject unfit for inclusion
•8\)Prior hormonal therapy, immunotherapy or approved or experimental antibody/proteins \= 30 days before inclusion (excluding panitumumab)
•9\)Any investigational agent within 30 days prior to inclusion
•10\)Evidence of previous acute hypersensitivity reaction, of any grade, to any component of the treatment