A PHASE 3, MULTICENTER, RANDOMIZED, OPEN-LABEL TRIAL TO EVALUATE THE SURVIVAL BENEFIT OF PANITUMUMAB AND BEST SUPPORTIVE CARE, COMPARED TO BEST SUPPORTIVE CARE ALONE, IN SUBJECTS WITH CHEMOREFRACTORY WILD-TYPE KRAS METASTATIC COLORECTAL CANCER

ABSTRACT: 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 250 DEATHS ARE OBSERVED, WHICHEVER IS LATER. THEREFORE, THE STUDY DURATION WILL BE APPROXIMATELY 54 MONTHS. SUBJECTS WILL BE STRATIFIED ACCORDING TO GEOGRAPHIC REGION (EUROPE VS. ASIA VS. REST OF THE WORLD) AND EASTERN COOPERATIVE ONCOLOGY GROUP (ECOG) PERFORMANCE STATUS (0 OR 1 VS. 2) AND RANDOMIZED (1:1 RATIO) TO RECEIVE EITHER PANITUMUMAB (ADMINISTERED INTRAVENOUSLY 6 mg/kg EVERY 14 DAYS) PLUS BSC OR BSC AS DETERMINED BY INSTITUTIONAL STANDARDS. CROSS-OVER FROM THE BSC ARM TO THE PANITUMUMAB PLUS BSC ARM IS NOT PERMITTED ON STUDY. RADIOGRAPHIC TUMOR ASSESSMENTS AND INVESTIGATOR´S ASSESSMENT OF RESPONSE USING RECIST VERSION 1.1 (EISENHAUER ET AL, 2009, APENDIX G), WILL BE PERFORMED AT WEEK 4 (+1 WEEK), WEEK 8 (± 1 WEEK) AND THEN EVERY 8 WEEKS (± 1 WEEK), UNTIL DISEASE PROGRESSION (RADIOGRAPHIC OR CLINICAL PROGRESSION) (SEE APPENDIX 7). SUBJECTS WIL BE TREATED UNTIL DISEASE PROGRESSION, WITHDRAWAL OF CONSENT, DEATH, INTOLERANCE OF STUDY DRUG (FOR THOSE ON THE PANITUMUMAB PLUS BSC ARM), AND WILL BE FOLLOWED FOR SURVIVAL UNTIL WITHDRAWAL OF CONSENT, DEATH, OR THE END OF THE LONG-TERM FOLLOW-UP PERIOD (SEE SECTION 7.1.5.1). Study Design: THIS IS AN OPEN-LABEL, MULTICENTER, RANDOMIZED PHASE 3 STUDY WITH A PLANNED ENROLLMENT OF APPROXIMATELY 350 PATIENTS.

PROVIDER: 2563336 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR