Study of Imprime PGG in Combination With Cetuximab in Subjects With Recurrent or Progressive KRAS Wild Type Colorectal Cancer
Ontology highlight
ABSTRACT: 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.
DISEASE(S): Colorectal Cancer Recurrent,Colorectal Cancer,Colorectal Neoplasms,Recurrent Or Progressive Kras Wild Type Colorectal Cancer
PROVIDER: 2103289 | ecrin-mdr-crc |
REPOSITORIES: ECRIN MDR
ACCESS DATA