Sponsor study identifier
interventional
10
0 countries
N/A
Study Start
March 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
November 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
This pilot clinical trial plans to carry out dabrafenib adjuvant therapy combined with lesion curettage after fenestrated decompressive surgery for BRAF mutation-positive multicystic ameloblastoma to explore the effectiveness of this therapy in preventing tumor recurrence, reducing or even avoiding postoperative deformity and dysfunction. effect. Based on this, we plan to launch a prospective clinical study of dabrafenib in the treatment of BRAF V600E ameloblastoma, verify the feasibility of drug treatment or drug-assisted treatment of ameloblastoma, and provide patients with a safer Effective new treatment options will benefit more patients.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 8, 2024
Actual (reported)February 20, 2024
Actual (reported)March 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
November 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
objective response rate
It is defined as the proportion of patients whose tumor volume has been reduced by 40% between treatment after fenestration decompression and before curettage, that is, the sum of the proportions of complete response (CR) and partial response (PR).
2 months after fenestration decompression
Relapse-free survival
2 years after tumor curettage
This study is a single-arm study that does not involve randomization or blinding, nor does it establish a parallel control group and uses external control.
Generic name: Dabrafenib mesylate capsules Dosage form: capsule Specifications: 50mg, calculated as C23H20F3N5O2S2 Usage: Orally The dose of dabrafenib is 150 mg twice daily (equivalent to a total daily dose of 300 mg), taken at least 1 hour before or 2 hours after a meal. If you miss a dose and it is less than 6 hours before the next dose, you should not take it. Patients who undergo fenestrated decompression will be administered the drug for 8 weeks, with curettage performed between weeks 8 and 9. Patients undergoing curettage will continue to take dabrafenib preoperatively until a few hours before surgery, but ideally, patients will take dabrafenib within 12 hours before surgery.
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Qing Li
Shandong University School of Stomatology
First Submitted
February 8, 2024
First Posted
February 20, 2024
Study Start
March 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Contact the study team to confirm eligibility.
Primary Completion
November 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
February 20, 2024
Record last verified: 2024-02
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Source: ClinicalTrials.gov.
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