Actively Recruiting
An Exploratory Study to Evaluate the Efficacy and Safety of FCN-159 in Patients With Brain Arteriovenous Malformations
Led by Xuanwu Hospital, Beijing · Updated on 2025-04-06
10
Participants Needed
1
Research Sites
83 weeks
Total Duration
On this page
Sponsors
X
Xuanwu Hospital, Beijing
Lead Sponsor
S
Shanghai Fosun Pharmaceutical Industry Development Co., Ltd
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
An Exploratory Study to Evaluate the Efficacy and Safety of FCN-159 in Patients With Brain Arteriovenous Malformations
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 60 years
- Diagnosis of brain arteriovenous malformation confirmed by digital subtraction angiography (DSA)
- Spetzler-Martin grade IV or V
- No history of rupture of the AVM vessels
- No aneurysmal structures suitable for interventional embolization
- No major surgery within the past 3 months
- Able to swallow and retain oral medication with no significant gastrointestinal issues affecting drug absorption
- Karnofsky Performance Score of 50% or higher
- Adequate organ and bone marrow function with specific blood counts and liver, kidney, and coagulation parameters within defined limits
- Voluntary written informed consent and ability to complete follow-up visits
- For patients of reproductive potential, agreement to use effective contraception during treatment and for at least 90 days after the last dose; male patients must avoid sperm donation for at least 90 days after last dose
You will not qualify if you...
- Multiple arteriovenous malformation lesions or extracranial AVM lesions
- Diagnosed with hereditary hemorrhagic telangiectasia, CM-AVM syndrome, PTEN hamartoma tumor syndrome, or CLOVES syndrome
- Prior stereotactic radiation therapy, surgery, interventional embolization, pharmacological treatment, or participation in other BAVM clinical trials after birth
- History of ruptured bleeding from malformed vascular clusters or other brain hemorrhage causes before screening
- Malignant tumors currently or within past 3 years except certain skin or in situ cancers
- Inability to undergo MRI or DSA or contraindications to these procedures
- Poorly controlled epilepsy
- Uncontrolled or unstable hypertension despite treatment
- Dysphagia, active gastrointestinal diseases, malabsorption, or other conditions affecting drug absorption
- Prior or current retinal vein occlusion, retinal pigment epithelium detachment, glaucoma, or significant eye abnormalities
- Interstitial lung disease including significant radiation pneumonitis
- Cardiac conditions including abnormal ECG findings, heart failure, arrhythmias, coronary artery disease, low ejection fraction, or bradycardia
- Family history of sudden cardiac death before age 50 in a first-degree relative
- Active bacterial, fungal, or viral infections including hepatitis B or C, or HIV
- Pregnant or breastfeeding women
- Known allergy to FCN-159, other MEK1/2 inhibitors, or excipients
- Any other factors deemed by the investigator that could lead to forced trial discontinuation such as severe diseases, psychiatric disorders, significant lab abnormalities, or social factors affecting safety or data collection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
the Department of Neurosurgery, China International Neuroscience Institute, Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, China, No. 45, Changchun Street
Actively Recruiting
Research Team
T
Tao Hong, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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