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Tests treatment safety and results for Brain Arteriovenous Malformations
Official title An Exploratory Study to Evaluate the Efficacy and Safety of FCN-159 in Patients With Brain Arteriovenous Malformations
ClinicalTrials.gov ID: NCT06913725
What this study is testing
What is FCN-159?
FCN-159 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for brain arteriovenous malformations.
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
- A single-center, open-label, non-randomized controlled exploratory study is conducted in the Xuanwu Hospital Capital Medical University to evaluate the efficacy and safety of FCN-159 in patients with brain arteriovenous malformations (BAVM), aiming to overcome the current clinical challenges caused by the lack of available drugs for this disease.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60
You may be able to join if
- Age ≥ 18 years and ≤ 60 years.
- Diagnosis of brain arteriovenous malformation (AVM) confirmed by DSA.
- Spetzler-Martin grade IV-V
- No history of rupture of the AVM vessels.
- No aneurysmal structures that are amenable to treatment embolization.
You likely can't join if
- Patients with multiple arteriovenous malformation lesions (excluding segmental lesions such as CAMS syndrome) or extracranial arteriovenous...
- Diagnosed with Hereditary Hemorrhagic Telangiectasia (HHT), Capillary Malformation-Arteriovenous Malformation syndrome (CM-AVM), PTEN Hamartoma Tumor...
- Patients who have received one of the following treatments after birth: a. Stereotactic radiation therapy, surgical treatment, or treatment...
- History of ruptured bleeding from malformed vascular clusters or other causes of brain hemorrhage, including subarachnoid hemorrhage, before the...
- Patients with malignant tumors currently or within the past three years, except for non-melanoma skin basal cell carcinoma, in situ breast cancer, or...
- Unable to undergo MRI scans and/or have contraindications to MRI (e.g., interference with MRI target lesion volume analysis due to prosthetics...
See the full eligibility criteria
- Age ≥ 18 years and ≤ 60 years.
- Diagnosis of brain arteriovenous malformation (AVM) confirmed by DSA.
- Spetzler-Martin grade IV-V
- No history of rupture of the AVM vessels.
- No aneurysmal structures that are amenable to treatment embolization.
- No major surgery within the past 3 months.
- Able to swallow and retain oral medication, with no significant gastrointestinal abnormalities that could affect drug absorption, such as malabsorption syndrome, bowel obstruction, or extensive gastrointestinal...
- Karnofsky Performance Score ≥ 50%
- The patient must have adequate organ and bone marrow function, and must not have received blood transfusions or used any supportive medications (such as cytokines or erythropoietin) to elevate white blood cells...
- The patient must voluntarily sign a written informed consent and be able to complete follow-up visits.
- For patients of reproductive potential: the patient must agree to use an effective contraceptive method, such as combined hormonal contraception, progestin-only contraception with ovulation suppression, intrauterine...
- Patients with multiple arteriovenous malformation lesions (excluding segmental lesions such as CAMS syndrome) or extracranial arteriovenous malformation lesions;
- Diagnosed with Hereditary Hemorrhagic Telangiectasia (HHT), Capillary Malformation-Arteriovenous Malformation syndrome (CM-AVM), PTEN Hamartoma Tumor Syndrome (PHTS), or CLOVES syndrome;
- Patients who have received one of the following treatments after birth: a. Stereotactic radiation therapy, surgical treatment, or treatment embolization for BAVM; b. Pharmacological treatment for BAVM; c. Participation...
- History of ruptured bleeding from malformed vascular clusters or other causes of brain hemorrhage, including subarachnoid hemorrhage, before the screening period;
- Patients with malignant tumors currently or within the past three years, except for non-melanoma skin basal cell carcinoma, in situ breast cancer, or in situ cervical cancer;
- Unable to undergo MRI scans and/or have contraindications to MRI (e.g., interference with MRI target lesion volume analysis due to prosthetics, braces, etc.);
- Unable to undergo DSA and/or have contraindications to DSA (e.g., contrast agent allergy, coagulopathy, etc.);
- Poorly controlled epilepsy;
- Uncontrolled, unstable hypertension: Repeated measurements showing systolic blood pressure \>140 mmHg or diastolic blood pressure \>90 mmHg with antihypertensive treatment;
- Dysphagia, active gastrointestinal diseases, malabsorption syndrome, or other conditions affecting the absorption of study drugs;
- Piror or current retinal vein occlusion (RVO), retinal pigment epithelium detachment (RPED), glaucoma, or other significant abnormalities in ophthalmologic examinations;
- Interstitial lung disease, including clinically significant radiation pneumonitis;
- Cardiac function or comorbidities that meet one of the following conditions: a. Three 12-lead ECG measurements conducted during the screening period at the study center, with an average QTcF \>470 ms calculated using...
- Family history of sudden cardiac death before the age of 50 in a first-degree relative;
- Active bacterial, fungal, or viral infections, including active hepatitis B (positive hepatitis B surface antigen and hepatitis B virus DNA \>1000 IU/ml, or meeting the study center's criteria for active hepatitis B...
- Pregnant or breastfeeding women;
- Known allergy to the study drug, other MEK1/2 inhibitors, or excipients;
- Any other factors determined by the investigator that may lead to forced discontinuation of the trial, such as severe diseases (including psychiatric disorders) requiring concomitant treatment, significant laboratory...
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
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, 18 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. 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.