A PHASE II / III STUDY OF TREATMENT WITH MK-0646 IN COMBINATION WITH CETUXIMAB AND IRINOTECAN FOR PATIENTS WITH METASTASIC COLORECTAL CANCER
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ABSTRACT: Interventions: Group name:Arm A Type of group;1 N° of participants:370 Intervention(s) description:Patients will be given an infusion of 10 mg / kg of MK-0646 for 60 minutes.
Group name:Arm C Type of group;2 N° of participants:370 Intervention(s) description:The MK-0646 will be replaced by saline. This saline placebo will be referred to hereinafter as placebo
Primary outcome(s): Outcome name:defined as the time from randomization to death due to any cause. Patients without, death documented at the time of the final analysis will be counted on the date of the last follow-up.
Measure:General survival
Timepoints:until the date of the last follow-up.
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Outcome name:defined as the time from randomization to the first documented evolution of the disease, as documented by an independent central laboratory, or death due to any cause, whichever occurs first.
Measure:Survival without evolution
Timepoints:to the first documented evolution of the disease, as documented by an independent central laboratory, or death due to any cause, whichever occurs first.
Study Design: This is a multicenter, double-blind, randomized, Phase II / III study of MK-0646 administered to patients with metastatic colorectal cancer who previously failed both chemotherapies based on oxaliplatin and irinotecan.
DISEASE(S): Malignant Neoplasm Of Colon
PROVIDER: 2563482 | ecrin-mdr-crc |
REPOSITORIES: ECRIN MDR
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