Clinical Study of Neoadjuvant Targeted Therapy for Ameloblastoma

Conditions

• Ameloblastoma
• BRAF V600E Mutation Positive

Eligibility Criteria

Sex

ALL

Age

18 Years - 65 Years

Healthy Volunteers

Not accepted

Interventions

• Dabrafenib — DRUG
  Dosage: 150 mg orally, twice daily (total daily dose of 300 mg) Administration: Administer at approximately 12 hours apart. Take at the same time each day. If a dose is missed and less than 6 hours remain until the next dose, skip the missed dose. Do not open, crush, or break the capsules. Usage in Combination: When used in combination with trametinib, trametinib should be taken once daily at the same time as either the morning or evening dose of dabrafenib to ensure synchronization of the treatment schedule.
• Trametinib — DRUG
  Dosage: 2 mg orally, once daily Administration: Administer at least 1 hour before or 2 hours after a meal. Take at the same time each day. If a dose is missed, it should be taken no later than 12 hours before the next scheduled dose; otherwise, skip the missed dose. Usage in Combination: When used in combination with trametinib, trametinib should be taken once daily at the same time as either the morning or evening dose of dabrafenib to ensure synchronization of the treatment schedule.

Study Details

This study aims to evaluate the tumor shrinkage effect of preoperative targeted induction therapy with dabrafenib and trametinib in patients with conventional ameloblastoma harboring the BRAF V600E mutation. The study will assess the proportion of cases where mandibular continuity cannot be preserved that can be converted to cases where mandibular continuity is preserved, as well as the proportion of cases where complete resection is initially not feasible that become resectable.

Key Dates

Start date

Jan 1, 2023

Status verified

Oct 2024

Primary completion

Dec 31, 2026

Completion

Dec 31, 2029

Study Design

Enrollment

12 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Dabrafenib and Trametinib Treatment Arm
  Dabrafenib: 150 mg twice daily, not to be taken if less than 6 hours remain to the next dose. Trametinib: 2 mg once daily, not to be taken if less than 12 hours remain to the next dose. Cycle Length: 30 days. Initial Follow-Up: After each of the first two cycles. Toxicity Management: Discontinue if intolerable toxicity occurs. Long-Term Follow-Up: Every two cycles. Criteria for Surgery: Confirmed by at least two chief physicians.

Primary Outcome Measure

Proportion of Patients Eligible for Mandibular Continuity-Preserving Surgery [ Time Frame: After completion of two 30-day cycles of therapy (approximately 2 months) ]

Central Contacts

• ZHAO Zhang
  +86 15150104115
  [email protected]