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Tests treatment safety and results for Primary Brain Tumor
Official title Belvarafenib for CNS Efficacy in Patients With BRAF-Altered Solid Tumors
ClinicalTrials.gov ID: NCT07688356
What this study is testing
What is Belvarafenib?
Belvarafenib is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for primary brain tumor.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a Phase 2, open-label, single-arm clinical study designed to evaluate the efficacy and safety of Belvarafenib in patients with BRAF-altered primary brain tumors (Cohort 1) and metastatic brain tumors (Cohort 2). Eligible patients are those with a confirmed BRAF alteration identified by next-generation sequencing (NGS).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 and older
You may be able to join if
- (Applicable to Both Cohorts)
- Male or female patients aged 19 years or older.
- Histologically confirmed primary brain tumor or metastatic brain tumor.
- Documented BRAF mutation, including point mutations (e.g., V600E) or BRAF fusion mutations.
- Willing and able to provide written informed consent prior to participation in the study.
You likely can't join if
- (Applicable to Both Cohorts)
- History of hypersensitivity to BRAF inhibitors or related compounds. Prior treatment with a BRAF inhibitor is permitted.
- Presence of hematologic malignancy or double primary malignancies at screening. The following second primary malignancies are permitted:
- Carcinoma in situ of the cervix successfully treated at least 1 year before enrollment;
- Papillary thyroid carcinoma treated with curative surgical resection;
- Completely resected cutaneous squamous cell carcinoma.
See the full eligibility criteria
Who can join
- (Applicable to Both Cohorts)
- Male or female patients aged 19 years or older.
- Histologically confirmed primary brain tumor or metastatic brain tumor.
- Documented BRAF mutation, including point mutations (e.g., V600E) or BRAF fusion mutations.
- Willing and able to provide written informed consent prior to participation in the study.
- Estimated life expectancy of at least 3 months.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
- Adequate organ function demonstrated by laboratory assessments performed within 14 days prior to the first dose of study treatment, meeting all of the following criteria:
- Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L
- Hemoglobin ≥ 9 g/dL
- Platelet count ≥ 100 × 10⁹/L
- PT/INR and aPTT ≤ 1.5 × upper limit of normal (ULN)
- Total bilirubin ≤ 1.5 × ULN (≤ 3 × ULN for patients with Gilbert syndrome)
- AST and ALT ≤ 2.5 × ULN (≤ 5 × ULN in patients with liver metastases)
- Alkaline phosphatase ≤ 2.5 × ULN (≤ 5 × ULN in patients with liver or bone metastases)
- Albumin ≥ 2.5 g/dL
- Amylase ≤ 1.5 × ULN
- Serum creatinine ≤ 1.5 × ULN or calculated creatinine clearance (CrCl) \> 50 mL/min using the Cockcroft-Gault formula
- Women of childbearing potential (defined as women from menarche until 1 year after menopause unless permanently sterile) and men with partners of childbearing potential must agree to use highly effective contraception...
- Hormonal contraception
- Intrauterine device (IUD) or intrauterine system (IUS)
- Vasectomy or bilateral tubal occlusion
- Complete abstinence Barrier methods (e.g., male or female condoms); if barrier methods are used alone, the use of two complementary barrier methods is recommended.
- Additional for Cohort 1 (Primary Brain Tumors) 1) Patients with BRAF-mutant primary brain tumors who meet at least one of the following conditions: \- No available or appropriate local treatment options (e.g., surgery...
- Radiographic evidence of disease recurrence or progression following standard therapy (including surgery and/or chemoradiotherapy [CCRT]), with no further suitable standard treatment available;
- Standard treatment is considered inappropriate or unavailable in the investigator's judgment.
- Additional for Cohort 2 (Metastatic Brain Tumors)
- Patients with brain metastases from BRAF-mutant solid tumors.
- Patients with radiographic evidence of disease progression after receiving the standard treatment for the primary malignancy, or whose disease is refractory to conventional therapy, regardless of prior exposure to...
- At least one measurable intracranial lesion, with a maximum of five target lesions, as defined by the Response Assessment in Neuro-Oncology (RANO) criteria.
What rules you out
- (Applicable to Both Cohorts)
- History of hypersensitivity to BRAF inhibitors or related compounds. Prior treatment with a BRAF inhibitor is permitted.
- Presence of hematologic malignancy or double primary malignancies at screening. The following second primary malignancies are permitted:
- Carcinoma in situ of the cervix successfully treated at least 1 year before enrollment;
- Papillary thyroid carcinoma treated with curative surgical resection;
- Completely resected cutaneous squamous cell carcinoma.
- Any of the following: \- Receipt of an investigational medicinal product within 28 days or within five half-lives (whichever is longer) before the first dose of study treatment; \- Major surgery within 28 days before...
- Newly initiated or recently increased systemic corticosteroid therapy equivalent to ≥10 mg/day of prednisolone within 28 days before the first dose.
- Patients receiving a stable dose for at least 2 weeks or requiring continued corticosteroid treatment after surgery may be enrolled at the investigator's discretion;
- Current treatment with systemic immunosuppressive agents or anticipated need for continuous systemic immunosuppression during the study. Topical preparations, inhaled corticosteroids, ophthalmic preparations, and local...
- More than five prior systemic anticancer treatment regimens.
- Unresolved adverse events of CTCAE Grade ≥2 from previous anticancer therapy at screening, except alopecia.
- Any of the following cardiovascular conditions:
- Mean QTcF \>440 msec;
- New York Heart Association (NYHA) Class III or IV heart failure;
- Cardiac metastasis;
- Uncontrolled electrolyte abnormalities (hyponatremia, hypokalemia, hypocalcemia, or hypomagnesemia);
- Within 6 months before the first dose: unstable angina, acute coronary syndrome (including myocardial infarction), uncontrolled arrhythmia (except sinus arrhythmia or adequately controlled atrial fibrillation for at...
- Coronary angioplasty, coronary/peripheral artery bypass graft surgery, or coronary stent placement within 6 months before the first dose;
- History of congenital long QT syndrome or clinically significant CTCAE Grade ≥2 ventricular or atrial dysrhythmias.
- Any of the following ophthalmologic disorders: \- History or evidence at screening of retinal vein occlusion (RVO), central serous retinopathy (CSR), or neovascular macular degeneration; \- Intraocular pressure ≥21 mmHg...
- Current or prior interstitial lung disease (ILD), drug-induced ILD, or radiation pneumonitis requiring corticosteroid treatment.
- Uncontrolled hypertension.
- Uncontrolled infectious or neurologic disease, active infection requiring intravenous antibiotics, known human immunodeficiency virus (HIV) infection, active hepatitis B virus (HBV) infection, or active hepatitis C...
- Inability to swallow oral tablets or any gastrointestinal condition that may interfere with the administration, absorption, or metabolism of Belvarafenib, including refractory nausea or vomiting, malabsorption syndrome...
- Requirement for continuous treatment with CYP2C8 substrate medications (e.g., amodiaquine) or rifampin.
- Known or suspected substance abuse or alcohol abuse.
- Psychological, social, geographic, psychiatric, or congenital conditions that, in the investigator's judgment, would interfere with compliance with the study protocol or follow-up.
- Pregnant or breastfeeding women, or women of childbearing potential planning to become pregnant during the study.
- Any other medical condition, laboratory abnormality, or circumstance that, in the investigator's judgment, would make the participant unsuitable for study treatment.
- Additional Exclusion Criteria for Cohort 1 (Primary Brain Tumors) 1) New intracranial lesions identified within 12 weeks after prior brain radiotherapy when radiation necrosis cannot be reliably distinguished from tumor...
- Additional Exclusion Criteria for Cohort 2 (Metastatic Brain Tumors) 1) Clinically unstable disease due to uncontrolled primary malignancy. 2) Requirement for concurrent systemic anticancer therapy (e.g., chemotherapy...
The study team makes the final eligibility decision.
Where it's taking place
- Seoul, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 19 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Seoul, South Korea. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.