Exploration of Fenestration Decompression Combined With Dalafenib in the Treatment of BRAF Mutant Ameloblastoma

Launched by SHANDONG UNIVERSITY · Feb 16, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment approach for patients with a specific type of tumor called ameloblastoma, which is linked to a genetic mutation known as BRAF V600E. The study aims to combine a drug called dabrafenib with a surgical procedure to help reduce the chances of the tumor coming back, while also minimizing any changes to the patient’s appearance or function after surgery. This trial is still in the planning stages and has not started recruiting participants yet.

To be eligible for this trial, patients need to be at least 18 years old and have been diagnosed with ameloblastoma that shows the BRAF V600E mutation. There are several health requirements that need to be met, such as certain blood test results and the ability to swallow medications. Additionally, participants will be asked to sign a consent form and commit to following the study guidelines. If you or a loved one is considering participating, you can expect to receive close monitoring during the treatment process and potentially gain access to a new, innovative therapy that could help manage this condition more effectively.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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.
• • 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.
• Exclusion Criteria:
• • 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.
• • 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.