AmeloblastomaPhase 3NCT06264778
Exploration of Fenestration Decompression Combined With Dalafenib in the Treatment of BRAF Mutant Ameloblastoma
A Phase 3 study testing Dabrafenib in people with Ameloblastoma, run by Shandong University.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Ameloblastoma
- What is being tested?
- Dabrafenib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2024to 31 Dec 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histology confirmed ameloblastoma.
- The patient was tested positive for BRAF V600E mutation.
- Eligible patients must have evaluable lesions within the jaw that meet RECIST criteria.
- Be 18 years or older.
- Laboratory test results:
- ANC > 1.5 x 109/L. PLT > 99 x 109/L. Hemoglobin >8 g/dL. Tbili < 1.6 × ULN. AST, ALT and alkaline phosphate < 2.6 times the upper limit of normal (ULN) . Serum creatinine ≤1.5 mg/dL, or serum creatinine >1.5 mg/dL, creatinine clearance must be ≥50ml/min.
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- PR / INR, PTT ≤ 1.3 × ULN, patients receiving anticoagulation therapy can participate in the trial if their INR is within the therapeutic range before randomization.
- Patients of childbearing potential must agree to use effective contraception for at least 6 months after treatment with dabrafenib.
- Be able to swallow and retain oral medications and must not have any clinically significant gastrointestinal abnormalities that may alter absorption, such as malabsorption syndrome or major resection of the stomach or intestines.
- The left ventricular ejection fraction is equal to or greater than normal within 1 month of enrollment.
- Voluntarily sign the informed consent form and cooperate with the treatment.
Who cannot join
- Those who have used BRAF inhibitor treatment in the past.
- Patients with invasive malignant tumors other than ameloblastoma within 3 years, excluding cancers with high cure rates, such as early cutaneous squamous cell carcinoma (T1 N0), cervical cancer, early prostate cancer, thyroid cancer, breast cancer Cancer and malignant tumors with confirmed activating RAS mutations at any time.
- Those who have had retinal vein occlusion in the past or currently.
- Those with a history of interstitial lung disease or lung inflammation.
- Those suffering from uncontrolled hypertension (systolic blood pressure > 140 mm Hg, diastolic blood pressure > 90 mm Hg, which cannot be controlled by antihypertensive treatment), heart failure or other serious medical diseases.
- Patients with previous allergic reactions caused by compounds with similar chemical or biological components to dabrafenib or trametinib.
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- Concomitantly taking strong CYP3A4 or CYP2C8 inhibitors (such as ketoconazole, nefazodone, clarithromycin, gemfibrozil) or strong inducers (such as rifampicin, phenytoin, carbamazepine, phenobarbide) appropriate).
- Those who take proton pump inhibitors, H2 receptor antagonists, and antacids at the same time.
- People with known G6PD deficiency.
- Pregnant or lactating patients. Women of childbearing potential must have a negative serum pregnancy test within 14 days of enrollment. Women of childbearing potential must agree to use effective contraception 14 days before enrollment, throughout treatment, and for 4 to 6 months after the last dose of study treatment.
- Those with electrogram QTcB > 480 ms within 14 days of enrollment.
- Patients with congestive heart failure NYHA grade III or more severe (physical activity is significantly limited).
- History of acute coronary syndrome (including myocardial infarction or unstable angina), coronary angioplasty or stent implantation within 6 months, or current clinically significant uncontrolled disease recorded by echocardiography History or evidence of arrhythmias or intracardiac defibrillators or cardiac valve morphological abnormalities (≥Grade 2). Subjects with grade 1 abnormalities (ie, mild regurgitation/stenosis) are eligible for enrollment. Subjects with moderate valve thickening were not eligible. Subjects with controlled atrial fibrillation for >30 days prior to dosing were eligible.
- Patients with previous systemic anti-cancer treatment (chemotherapy, immunotherapy, biological therapy, vaccine treatment within 3 weeks before study treatment, or chemotherapy without delayed toxicity within 2 weeks before study treatment).
- Any serious or unstable pre-existing illness, mental illness, or other condition that may affect subject safety, obtaining informed consent, or compliance with research procedures.
- History of hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. Subjects with laboratory evidence of cure of HBV and/or HCV will be admitted.
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the detailed description
Main purpose:
To verify the application value of dabrafenib, a targeted drug targeting BRAF V600E mutation, combined with fenestration decompression and tumor curettage therapy in the treatment of multicystic ameloblastoma. It is expected to provide patients with a new treatment option that improves curative effect, reduces postoperative tumor recurrence, and avoids postoperative deformity.
Secondary purpose:
Study of regional heterogeneity in BRAF V600E-mutant ameloblastoma. Provide new ideas for finding other effective treatments.
Overall research design This study is a single-center, single-arm exploratory study. It is planned to enroll 10 patients with BRAF V600E mutation-positive multicystic ameloblastoma. After signing the informed consent form, you can enter the study as a subject.
Subjects will receive the study drug dabrafenib immediately after window decompression surgery. They will take dabrafenib for at least 8 weeks. Lesion curettage will be performed within the 8th to 9th week. Preoperative imaging will check the tumor volume. zoomed out situation. Patients whose lesions are not completely curettaged may choose to resume the dose of dabrafenib they received immediately before surgery.
- Conditions
- Ameloblastoma
- Being tested
- Dabrafenib
- Keywords
- BRAF Gene Mutation, Fenestration decompression
- Medical subject headings
- Ameloblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DabrafenibDrug
Also called fenestration decompression
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.
| Study group | Role | What they receive |
|---|---|---|
| Dabrafenib | Experimental | 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. Receives: Drug: Dabrafenib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 2 months after fenestration decompression
Secondary outcomes (1)
Relapse-free survival
The time from tumor curettage to disease recurrence (local, regional or distant metastasis), whichever occurs first, is determined according to the investigator's assessment.
Measured: 2 years after tumor curettage
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start1 Mar 2024 (estimated)
- Primary completion1 Nov 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmeloblastomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Baihui Miao, Shandong University
- Investigators
- Qing Li, Principal investigator, Shandong University School of Stomatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06264778
- Sponsor's protocol ID
- 2023013
- Status last verified
- Feb 2024
- First submitted
- 8 Feb 2024
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploration of Fenestration Decompression Combined With Dalafenib in the Treatment of BRAF Mutant Ameloblastoma
- ClinicalTrials.gov ID
- NCT06264778
- Acronym / sponsor ID
- 2023013
- Conditions
- Ameloblastoma
- Keywords
- BRAF Gene Mutation, Fenestration decompression
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (estimated)
- Primary completion
- 1 Nov 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 20 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Main purpose:
To verify the application value of dabrafenib, a targeted drug targeting BRAF V600E mutation, combined with fenestration decompression and tumor curettage therapy in the treatment of multicystic ameloblastoma. It is expected to provide patients with a new treatment option that improves curative effect, reduces postoperative tumor recurrence, and avoids postoperative deformity.
Secondary purpose:
Study of regional heterogeneity in BRAF V600E-mutant ameloblastoma. Provide new ideas for finding other effective treatments.
Overall research design This study is a single-center, single-arm exploratory study. It is planned to enroll 10 patients with BRAF V600E mutation-positive multicystic ameloblastoma. After signing the informed consent form, you can enter the study as a subject.
Subjects will receive the study drug dabrafenib immediately after window decompression surgery. They will take dabrafenib for at least 8 weeks. Lesion curettage will be performed within the 8th to 9th week. Preoperative imaging will check the tumor volume. zoomed out situation. Patients whose lesions are not completely curettaged may choose to resume the dose of dabrafenib they received immediately before surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Dabrafenib | Experimental | Drug: DabrafenibThis 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Histology confirmed ameloblastoma.
- The patient was tested positive for BRAF V600E mutation.
- Eligible patients must have evaluable lesions within the jaw that meet RECIST criteria.
- Be 18 years or older.
- Laboratory test results:
Key exclusion criteria (16 listed)
- Those who have used BRAF inhibitor treatment in the past.
- Patients with invasive malignant tumors other than ameloblastoma within 3 years, excluding cancers with high cure rates, such as early cutaneous squamous cell carcinoma (T1 N0), cervical cancer, early prostate cancer, thyroid cancer, breast cancer Cancer and malignant tumors with confirmed activating RAS mutations at any time.
- Those who have had retinal vein occlusion in the past or currently.
- Those with a history of interstitial lung disease or lung inflammation.
- Those suffering from uncontrolled hypertension (systolic blood pressure > 140 mm Hg, diastolic blood pressure > 90 mm Hg, which cannot be controlled by antihypertensive treatment), heart failure or other serious medical diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DabrafenibAlso: fenestration decompressionGeneric 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. | Drug | Dabrafenib |
Primary outcome
objective response rate
Time frame: 2 months after fenestration decompression
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).
1 secondary outcome
Relapse-free survival
Time frame: 2 years after tumor curettage
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- Individual participant dataSharing planned: No
Related trials for Ameloblastoma
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Neoadjuvant Therapy With Conservative Surgery vs. Up-front Conservative Surgery for BRAF V600E-Mutated Ameloblastoma
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Clinical Study of Neoadjuvant Targeted Therapy for Ameloblastoma
Ameloblastoma, BRAF V600E Mutation Positive
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Qing Li principal investigator
Shandong University School of Stomatology
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dabrafenib in people with Ameloblastoma, run by Shandong University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Baihui Miao (+8618845727762, 18845727762@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
objective response rate (time frame: 2 months after fenestration decompression). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2024.