NCT06653517|RecruitingPhase 2DMC
Clinical Study of Neoadjuvant Targeted Therapy for Ameloblastoma
NETCAM
Neoadjuvant BRAFV600E-Targeted Therapy for Conventional Ameloblastoma of the Jaw:A Single-Arm Clinical Study
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Sponsor study identifier
interventional
12
1 country
1
Study Start
January 1, 2023
Actual (reported)Primary Completion
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 1, 2023
Actual (reported)October 15, 2024
Actual (reported)October 22, 2024
Actual (reported)December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 31, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Proportion of Patients Eligible for Mandibular Continuity-Preserving Surgery
The proportion of patients initially requiring mandibular segmental resection who become eligible for mandibular continuity-preserving surgery after preoperative targeted induction therapy with dabrafenib and trametinib.
After completion of two 30-day cycles of therapy (approximately 2 months)
Proportion of Non-radical Resectable Cases Becoming Resectable
The proportion of patients initially deemed non-radical resectable who become resectable after completing two cycles of preoperative targeted induction therapy with dabrafenib and trametinib.
After completion of two 30-day cycles of therapy (approximately 2 months)
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.
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.
Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200011, China
CAO Wei, PHD;MD
Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China
First Submitted
October 15, 2024
First Posted
October 22, 2024
Study Start
January 1, 2023
Actual (reported)Primary Completion
December 31, 2026
EstimatedRadiological Response
After completion of two 30-day cycles of therapy (approximately 2 months)
Pathological Response
After completion of two 30-day cycles of therapy (approximately 2 months)
Local Recurrence-Free Survival (LRFS)
3 months
Adverse Effects and Safety
Throughout the study period, up to 12 months
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.
Contact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 22, 2024
Record last verified: 2024-10
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