EUCTR2017-004519-38-ESActive, not recruitingPhase 1
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 enrollmentStarted: April 9, 2018Last updated:
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 85
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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 <2.5 x ULN; or in case of liver metastasis ALT and AST <5 x ULN
- •- Renal function, calculated as creatinine clearance or 24-hour creatinine clearance = 50 mL/min
- •- Magnesium > 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
- •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.
Investigators
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