Spots Global Cancer Trial Database for Dabrafenib Plus Trametinib in Patients With Advanced Solid Tumor Having BRAF V600E Mutation or Clinically Actionable BRAF Gene Alterations

Study Description

Brief Summary: 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.

Detailed Description: 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.

Keywords

Eligibility

Minimum Age: 19 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

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