Dabrafenib Plus Trametinib in Patients With Advanced Solid Tumor Having BRAF V600E Mutation or Clinically Actionable BRAF Gene Alterations

Sponsor
Se Jun Park
Study ID
NCT05876806
Phase
PHASE2
Status
Unknown

Conditions

  • Cancer

Eligibility Criteria

Sex
ALL
Age
19 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dabrafenib — DRUG
    Dabrafenib is a 150 mg twice daily capsule administered orally on a continuous basis
  • Trametinib — DRUG
    Trametinib is a 2 mg once daily tablet administered orally on a continuous basis.

Study Details

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.

Key Dates

Start date
Jun 20, 2023
Status verified
Nov 2023
Primary completion
Mar 31, 2026
Completion
Mar 31, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Disease Control Rate (DCR) [ Time Frame: From study treatment start date until first documented complete response, partial response or stable disease, assessed up to 36 months ]

Central Contacts

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