Se Jaune Park
Se Jaune Park
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.
Cancer
Dabrafenib
Trametinib
Phase 2
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 |
Estimated Enrollment : | 30 participants |
Masking : | None (Open Label) |
Primary Purpose : | Treatment |
Official Title : | A Phase II, Open-label Study of Dabrafenib Plus Trametinib in Patients With Advanced Solid Tumor Having BRAF V600E Mutation or Clinically Actionable BRAF Gene Alterations |
Actual Study Start Date : | June 20, 2023 |
Estimated Primary Completion Date : | March 2026 |
Estimated Study Completion Date : | March 2026 |
Arm | Intervention/treatment |
---|---|
Experimental: Dabrafenib + Trametinib Subjects will receive Dabrafenib 150 mg twice daily orally plus Trametinib 2 mg once daily orally on a continuous basis. A treatment cycle is 28 days in duration. Subjects will continue treatment until an unacceptable toxicity, disease progression, or death occurs. |
Drug: Dabrafenib Drug: Trametinib |
Ages Eligible for Study: | 19 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Recruiting
Seoul St. Mary's Hospital, The Catholic University of Korea
Seoul, Korea, Republic of, 06591