The primary objective of this study is to compare the additive efficacy of SIM versus placebo in combination with leucovorin (folinic acid), irinotecan, and fluorouracil (FOLFIRI) as measured by improvement in progression-free survival (PFS) in participants with metastatic KRAS mutant colorectal adenocarcinoma who have progressed following a first-line oxaliplatin- and fluoropyrimidine-containing regimen.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
266
SIM administered via intravenous infusion over 30 minutes
Placebo to match SIM administered via intravenous infusion over 30 minutes
l-Leucovorin 200 mg/m\^2 or dl-leucovorin 400 mg/m\^2 administered via intravenous infusion over 2 hours
Progression Free Survival (PFS)
The PFS was defined as the time from the date of randomization to the earliest event time of: a) death regardless of cause, or b) first indication of disease progression. PFS was analyzed using Kaplan-Meier (KM) estimates.
Time frame: Randomization up to 27 months
Overall Survival (OS)
The OS is measured as time from date of randomization to death regardless of cause. The OS was analyzed using KM estimates.
Time frame: Randomization up to 33 months
Objective Response Rate (ORR)
Objective response was assessed using the Response Evaluation Criteria in Solid Tumors (RECIST) criteria (version 1.1) as Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD). The ORR was defined as the percentage of participants who achieved a CR or PR.
Time frame: Randomization up to 27 months
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Irinotecan 180 mg/m\^2 administered via intravenous infusion over 90 minutes
Fluorouracil 400 mg/m\^2 administered via intravenous bolus and 2400 mg/m\^2 via intravenous infusion over 46 hours
Clearview Cancer Institute
Huntsville, Alabama, United States
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States
Central Hematology Oncology Medical Group, Inc.
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Comprehensive Blood and Cancer Center
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Providence Saint Joseph Medical Center-Disney Family Cancer Center
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Wilshire Oncology Medical Group, Inc.
Corona, California, United States
Saint Jude Heritage Healthcare
Fullerton, California, United States
University of California San Diego Medical Center
La Jolla, California, United States
Pacific Shores Medical Group
Long Beach, California, United States
Comprehensive Hematology Oncology Centers, Inc.
Los Angeles, California, United States
...and 99 more locations