This is a 2-part Phase 1b study of BGB-283 (lifirafenib) and PD-0325901 (mirdametinib) combination in participants with tumors.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
91
RAF Dimer Inhibitor
MEK Inhibitor
University of California Los Angeles
Santa Monica, California, United States
MD Anderson
Houston, Texas, United States
Blacktown Cancer and Haematology Centre
Blacktown, New South Wales, Australia
The Prince of Wales Private Hospital - Specialist Medical Randwick
Randwick, New South Wales, Australia
Adverse Events and Serious Adverse Events
Incidence and severity of AEs and SAEs and graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0
Time frame: Approximately 2 years from date of the participants enrollment
The incidence of DLT events and treatment-emergent AEs (TEAEs)
Time frame: Approximately 2 years from date of the participants enrollment
Objective response rate based on Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 in participants with selected tumor types
Time frame: Approximately 2 years from date of the participants enrollment
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Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia
Linear Clinical Research
Nedlands, Western Australia, Australia