None listed
Conditions
Interventions
THE SUBJECT ACCRUAL PERIOD IS PLANNED AL APPROXIMATELY 30 MONTHS. SUBJECTS WILL BE FOLLOWED FOR SURVIVAL FOR UP TO 24 MONTHS AFTER THE LAST SUBJECT IS RANDOMIZED IN THE STUDY OR UNTIL APPROXIMATELY
Sponsors
AMGEN INC.,
Eligibility
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. DISEASE RELATED 101. HISTOLOGICALLY OR CYTOLOGICALLY CONFIRMED DIAGNOSIS OF ADENOCARCINOMA OF THE COLON OR RECTUM. - METASTATIC DISEASE. 102. WILD TYPE (WITHOUT MUTATION IN CODONS 12 AND 13) KRAS GENE IN TUMOR TISSUE CONFIRMED BY A CENTRAL LABORATORY (REFER TO SECTION 7.2). - KRAS MUTATIONAL ANALYSIS MAY HAVE BEEN PERFORMED BY THE CENTRAL LABORATORY PRIOR TO OBTAINING CONSENT FOR STUDY. - FORMAIN-FIXED PARAFFIN-EMBEDDED TUMOR TISSUE FROM EITHER THE PRIMARY TUMOR OR A METASTATIC LESION MUST BE AVALAIBLE AND SUBMITTED TO AMGEN APPROVED CENTRAL LABORATORY FOR KRAS TESTING AND/OR OTHER BIOMARKER TESTING. 103. ECOG PERFORMANCE STATUS O, 1 OR 2 (REFER TO APPENDIX 6). 104. AT LEAST 1 MEASURABLE OR NON-MEASURABLE LESION PER RECIST VERSION 1.1. GUIDELINES LESION MUST NOT BE CHOSEN FROM A PREVIOUSLY IRRADIATED FIELD UNLESS THERE HAD BEEN DOCUMENTED TUMOR PROGRESSION IN THAT LESION PRIOR THE RANDOMIZATION. ALL SITES OF DISEASE MUST BE EVALUATED ≤ 28 DAYS PRIOR TO RANDOMIZATION.
Exclusion criteria
Exclusion criteria: 1. DISEASE RELATED 201. SYMPTOMATIC BRAIN METASTASES REQUIRING TREATMENT. 202. HISTORY OF OTHER MALIGNANCY, EXCEPT: . MALIGNANCY TREATED WITH CURATIVE INTENT AND WITH NO KNOWN ACTIVE DISEASE PRESENT FOR ≥ 5 YEARS PRIOR TO RANDOMIZATION AND FELT TO BE AT LOW RISK FOR RECURRENCE BY THE TREATING PHYSICIAN. . ADEQUATELY TREATED NON-MELANOMATOUS SKIN CANCER OR LENTIGO MALIGNA WITHOUT EVIDENCE OF DISEASE. . ADEQUATELY TREATED CERVICAL CARCINOMA IN SITU WITHOUT EVIDENCE OF DISEASE. . PROSTATIC INTRAEPITHELIAL NEOPLASIA WITHOUT EVIDENCE OF PROSTATE CANCER. 2. MEDICATIONS 203. PRIOR ANTI-EGFR ANTIBODY THERAPY (eg., PANITUMUMAB OR CETUXIMAB) OR TREATMENT WITH SMALL MOLECULE EGFR INHIBITORS (eg., GEFITINIB, ERLOTINIB, LAPATINIB). 204. ANTITUMOR THERAPY (eg., CHEMOTHERAPY, HORMONAL THERAPY, IMMUNOTHERAPY, ANTIBODY THERAPY) ≤ 21 DAYS BEFORE RANDOMIZATION. SUBJECTS MUST HAVE RECOVERED FROM ANY ACUTE TOXICITY. 205. RADIOTHERAPY ≤ 14 DAYS BEFORE RANDOMIZATION. SUBJECTS MUST HAVE RECOVERED FROM ANY ACUTE RADIOTHERAPY-RELATED TOXICITIES.
Countries
Brazil, Canada, Chile, China, Croatia, Estonia, Greece, India, Korea North, Lithuania, Malasya, Mexico, Peru, Philippines, Romania
Contacts
Public ContactGabriela Celina Loyola
IQVIA RDS Peru S.R.L
Outcome results
None listed