Patients with metastatic colorectal cancer MedDRA version: 9.1 Level: LLT Classification code 10052362 Term: Metastatic colorectal cancer
Conditions
Sponsors
Amgen Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients will be eligible to participate in the study if they meet all of the criteria listed below. 1. Ethical Competent to comprehend, sign, and date an IEC-approved informed consent form. 2. Demographic Of either gender and aged 18 years or more. 3. Disease-related •Diagnosed with histologically- or cytologically-confirmed metastatic adenocarcinoma of the colon and/or rectum. •Measurable disease according to modified RECIST guidelines. All sites of disease must have been evaluated within 28 days of initiating study treatment, and diagnosed by the investigator. •Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2. •Have available paraffin-embedded tissue or unstained tumour slides from primary or metastatic tumour. 4. Laboratory -Haematologic function, as follows (within seven days prior to initiating study treatment): • Absolute neutrophil count (ANC) = 1.5 x 109/L. • Platelet count =100 x 109/L. • Haemoglobin =10 g/dL. -Renal function, as follows (within seven days prior to initiating study treatment): • Creatinine =1.5 mg/dL. -Hepatic function, as follows (within seven days prior to initiating study treatment): • Aspartate aminotransferase (AST) =3 x ULN (if liver metastases = 5 x ULN). • Alanine aminotransferase (ALT) =3 x ULN (if liver metastases = 5 x ULN). • Bilirubin = 2 x ULN. -Metabolic function, as follows (within seven days prior to initiating study treatment): • Magnesium = lower limit of normal. • Calcium = lower limit of normal. 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Any patient exhibiting any of the criteria listed below will be excluded from the study: 1. Disease Related • Central nervous system metastases (Exception: subjects who have been treated, have asymptomatic central nervous system metastases, and have been off steroids for at least 30 days before initiating study treatment are eligible). 2. Therapies • Prior systemic therapy for the treatment of metastatic colorectal carcinoma with the exception of adjuvant fluoropyrimidine-based chemotherapy given at least six months prior to initiating study treatment. • Prior anti-EGFr antibody therapy (e.g.: cetuximab) or treatment with small molecule EGFr tyrosine kinase inhibitors (e.g.: erlotinib). • Prior radiotherapy within 14 days prior to screening, and for which all signs of early radiological toxicity have not abated. 3. General • Significant cardiovascular disease including unstable angina or myocardial infarction within six months before initiating study treatment or a history of ventricular arrhythmia. • History of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial pneumonitis or pulmonary fibrosis on baseline chest CT scan. • Treatment for systemic infection within 14 days before initiating study treatment. • Active inflammatory bowel disease or other bowel disease causing chronic diarrhoea (defined as > 4 loose stools per day). • History of Gilbert’s syndrome or dihydropyrimidine deficiency. • History of any medical condition that may increase the risks associated with study participation or may interfere with the interpretation of the study results. • Known positive test for human immunodeficiency virus infection, hepatitis C virus, chronic active hepatitis B infection. • Any co-morbid disease that would increase risk of toxicity. • Any kind of disorder that compromises the ability of the subject to give written informed consent and/or comply with the study procedures. • Any investigational agent within 30 days before initiation of study treatment. • Must not have had a major surgical procedure within 28 days prior to initiation of study treatment. • Subject who is pregnant or breast-feeding. • Woman or man of childbearing potential not consenting to use adequate contraceptive precautions i.e. double barrier contraceptive methods (e.g. diaphragm plus condom) during the course of the study and for six months after the last study drug administration for women, and one month for men. • Subject unwilling or unable to comply with study requirements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To estimate the effect of KRAS mutation status (wild-type versus mutant) on objective response rate and other measures of efficacy for subjects treated with panitumumab in combination with a chemotherapy regimen of irinotecan, 5- luorouracil (5-FU) and leucovorin (FOLFIRI) as 1st-line therapy for metastatic colorectal cancer (mCRC).;Secondary Objective: To describe the safety profile of this combination therapy in the 1st- line setting including the incidence of AE’s and significant changes in laboratory parameters. Exploratory objectives: To explore measures of patient reported outcomes (PRO), healthcare resource utilisation and any integument and eye toxicity management scheme;Primary end point(s): Objective response rate (ORR): Incidence of either a confirmed complete or partial response; subjects prematurely discontinuing without a post-baseline tumour response assessment or subjects who do not meet the criteria for an objective response by the analysis data cut-off date will be considered non-responders. | — |
Countries
Austria, France, Germany, Sweden
Outcome results
None listed