The is a double-blind, randomized phase 3 study of 90Y-clivatuzumab tetraxetan with low-dose gemcitabine, versus placebo and low-dose gemcitabine in metastatic pancreatic cancer patients who have progressed on at least 2 prior therapies for metastatic cancer (1 of which was a gemcitabine-containing regimen).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
334
Arm A: gemcitabine 200 mg/m2 administered weekly x 4 and IMMU-107 administered weekly x 3 for multiple cycles
placebo weekly x 3 and gemcitabine 200 mg/m2 weekly x 4 for multiple cycles
Gemcitabine, 200 mg/m2, given weekly x 4 in both arms
overall survival
Time frame: 24 months
Overall survival
Time frame: 3, 6 and 12 months
Objective tumor response
Time frame: 24 months
Progression free survival
Time frame: 24 months
Clinical benefit
quality of life will be assessed over 24 months using the FACT-hepatopancreatic form
Time frame: 24 months
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Banner MD Anderson
Gilbert, Arizona, United States
City of Hope National Medical Center
Duarte, California, United States
Pacific Shores Medical Group
Long Beach, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
Whittingham Cancer Center
Norwalk, Connecticut, United States
Michael and Dianne Bienes Comprehensive Cancer Center - Holy Cross Hospital
Fort Lauderdale, Florida, United States
Baptist Cancer Institute
Jacksonville, Florida, United States
Cancer Specialists of North Florida
Jacksonville, Florida, United States
Mountain States Tumor Institute at St. Luke's Regional Medical Center
Boise, Idaho, United States
Illinois Cancer Specialists
Arlington Heights, Illinois, United States
...and 54 more locations