Subjects treated in first-line with panitumumab and FOLFOX and having at least achieved stable disease with wild type RAS metastatic Colorectal Cancer confirmed in liquid biopsies before starting second line treatment will be screened for this trial. Only subjects who have interrupted panitumumab for < 3 months (panitumumab continuation) will be included MedDRA version: 20.0 Level: LLT Classification code 10052362 Term: Metastatic colorectal cancer System Organ Class: 100000004864
Conditions
Interventions
Trade Name: Vectibix 20 mg/ml concentrado para solución para perfusión
Product Name: Panitumumab
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: PANITUMUMAB
CAS Number:
Sponsors
Grupo Español Multidisciplinar en Cáncer Digestivo (GEMCAD
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 11)Hepatic, renal and metabolic function as follows: - Total bilirubin count =1.5 x upper limit of normal (ULN), ALT and AST lower limit of normal (LLN) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 80 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: 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 11)History of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial pneumonitis or pulmonary fibrosis on baseline chest computerised tomography 12)Acute or subacute intestinal occlusion and/or active inflammatory bowel disease or other bowel disease that causes chronic diarrhoea (defined as grade = 2 diarrhoea according to Common Terminology Criteria for Adverse Events (CTCAE) v 4.03) 13)Significant cardiovascular disease including unstable angina or myocardial infarction within 12 months before initiating study treatment or a history of ventricular arrhythmia 14)History of Gilbert disease or known dihydropyrimidine deficiency syndrome 15)Known positive test for human immunodeficiency virus infection, hepatitis C virus, chronic active hepatitis B infection 16)Treatment for systemic infection within 14 days before the start of study treatment 17)Clinically significant peripheral sensory neuropathy 18)History of any disease that may increase the risks associated with study participation or may interfere with the interpretation of study results 19)Surgery (excluding diagnostic biopsy or placement of a central venous catheter) and/or radiotherapy within 28 days prior to inclusion in the study. 20)Pregnant or breastfeeding woman 21)Male or female of childbearing age who do not agree with taking adequate contraceptive precautions, i.e. use contraception double barrier (e.g diaphragm plus condoms) or abstinence during the course of the study and for 6 months after the last administration of study drug for women and 1 month for men 22)The subject is unwilling or unable to meet the requirements of the study 23)Psychological, geographical, familial or sociological conditions that potentially prevent compliance with the study protocol and follow-up schedule. These conditions should be discussed with the subject before inclusion in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 6-month Progression -free survival , defined as the proportion of subjects still alive and progression free at 6 months.;Secondary Objective: •Progression-free survival (PFS), from the date of randomization to progression or death. •Proportion of subjects with an objective response (complete or partial response) according to RECIST 1.1 criteria •Overall survival •Safety and tolerability. •Conversion rate of RAS/BRAF status according to liquid biopsy determinations at second-line treatment initiation and at the time of disease progression after second-line treatment;Primary end point(s): 6-month PFS(Progression-free survival) defined as the proportion of subjects still alive and progression free at 6 months.;Timepoint(s) of evaluation of this end point: Six months after inclusion of the last patient in the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •Progression-free survival (PFS), from the date of randomization to progression or death, •Proportion of subjects with an objective response (complete or partial response) according to RECIST 1.1 criteria •Overall survival (OS), defined as the time (months) from randomization to the date of death, •Conversion rate of RAS/BRAF status according to liquid biopsy determinations at second-line treatment initiation and at the time of disease progression after second-line treatment •Safety : -Incidence and severity of AEs (according to the NCI (National Cancer Institute) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03) -Changes in laboratory values -Changes in vital signs -Incidence of dose adjustments -Incidence of concomitant medication -Changes from baseline in Eastern Cooperative Oncology Group (ECOG) performance status;Timepoint(s) of evaluation of this end point: 20 months after inclusion of the last patient in the study. | — |
Countries
Spain
Contacts
Public ContactLydia Talavera (Clinical Operation)
Pivotal, S.L.
Outcome results
None listed