Colorectal Cancer Clinical Trial
Official title:
A Phase 3 Open-Label, Randomized, Multicenter Study of Imprime PGG® in Combination With Cetuximab (Erbitux®) in Subjects With Recurrent or Progressive KRAS Wild Type Colorectal Cancer
Study BT-CL-PGG-CRC1031 is a Phase 3, open-label, randomized, multi-center study. Qualified subjects, who have KRAS wild type (WT) colorectal cancer will be randomized in a 2:1 ratio to treatment with either Imprime PGG and cetuximab or cetuximab alone. Subjects will be dosed until progression or discontinuation for some other reason. Efficacy will be assessed via Response Evaluation Criteria in Early Tumors 1.1 (RECIST 1.1); computed tomography (CT) scans will be conducted every 6 weeks. Safety, pharmacokinetics (PK), quality of life, and biomarker parameters will also be assessed.
Study BT-CL-PGG-CRC1031 is a Phase 3, open-label, randomized, multi-center study. Qualified
subjects, who have KRAS WT colorectal cancer will be randomized in a 2:1 ratio to either:
Arm 1: Imprime PGG and cetuximab or Arm 2: Cetuximab
Approximately 795 subjects will be randomized into the study. Dosing will occur in 6-week
cycles. Imprime PGG will be dosed at 4 mg/kg and will be administered weekly in each cycle
(Weeks 1-6/Days 1, 8, 15, 22, 29, and 36) preceding the administration of cetuximab (Arm 1
only). The initial cetuximab dose (both arms) will be 400 mg/m2 on Cycle 1/Day 1 and
subsequent doses will be 250 mg/m2 administered weekly in each cycle (Weeks 1-6/Days 1, 8,
15, 22, 29, and 36).
Subjects will be dosed until progressive disease (PD) per RECIST 1.1 or discontinuation of
study drug for other reasons; e.g., safety. Following completion of the treatment period of
the study, subjects will be monitored for survival until death or loss to follow-up. Tumor
measurements and determination of tumor responses will be evaluated according to RECIST 1.1.
Safety, PK, quality of life, and biomarker parameters will also be assessed.
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