This is a Phase II, open-label, non-randomized, multi-center study of oral Dabrafenib in combination with oral Trametinib in subjects with solid tumors with BRAF V600E mutation or clinically actionable BRAF gene alterations.
Dabrafenib and trametinib combination treatment can offer a therapeutic option for patients with solid cancers harboring specific gene mutations, for whom there are no alternative treatments. Patients with BRAF V600 mutated advanced solid tumor (excluding BRAF V600E/K mutated malignant melanoma, BRAF V600E mutated non-small cell lung cancer, and BRAF V600E mutated colorectal cancer) or patients with other BRAF gene alterations that are regarded to be druggable by the KOSMOS MTB. This study is designed to determine the disease control rate (DCR) of oral Dabrafenib in combination with oral Trametinib in subjects with BRAF V600E or clinically actionable BRAF mutated cancers. Only subjects with histologically confirmed advanced disease and no available standard treatment options will be eligible for enrollment. Subjects will undergo screening assessments within 30 days prior to the start of treatment to determine their eligibility for enrollment in the study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Dabrafenib is a 150 mg twice daily capsule administered orally on a continuous basis
Trametinib is a 2 mg once daily tablet administered orally on a continuous basis.
Seoul St. Mary's Hospital, The Catholic University of Korea
Seoul, South Korea
RECRUITINGDisease Control Rate (DCR)
Disease control Rate (DCR) is defined as the proportion of subjects with objective evidence of complete response (CR), partial response (PR), or stable disease (SD).
Time frame: From study treatment start date until first documented complete response, partial response or stable disease, assessed up to 36 months
Overall Survival (OS)
Overall Survival (OS) is defined as the time from first dose until death due to any cause.
Time frame: From study treatment start date until date of of death from any cause, assessed up to 36 months
Progression Free Survival (PFS)
Progression Free Survival (PFS) is defined as the interval between the first dose of study treatment and earlier date of first radiologically documented progression or death due to any cause.
Time frame: From study treatment start date until date of radiographic progression or date of death from any cause, whichever comes first, assessed up to 36 months
Objective Response Rate (ORR)
Overall Response Rate (ORR) is defined as the percentage of participants with a confirmed overall response by investigator assessment as defined by the pre-specified response criteria.
Time frame: From study treatment start date until first documented complete response or partial response, assessed up to 36 months
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