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Clinical Trials in China / NCT07072403
Active, not recruiting Phase 1/2

Trametinib Treatment for Complicated Vascular Anomalies

NCT07072403 · tracked via the Priya Life Science China tracker
Sponsor
West China Hospital
Phase
Phase 1/2
Started
2025-07-07
Last updated
2025-07-22

Condition(s) studied

Vascular Anomalies

Investigational drug(s) / intervention(s)

Trametinib tablet →

Trametinib tablet: Drug is supplied in 0.5 mg and 2 mg tablets

Study summary

Complicated vascular anomalies have diverse etiologies and variable clinical manifestations, and no standardized treatment protocol has been established. Since most patients present with diffuse lesions that are difficult to resect surgically, identifying effective therapeutic strategies is of critical importance. This study aims to evaluate the safety and efficacy of systemic trametinib therapy in patients with complicated vascular anomalies.

Eligibility

Sex
ALL
Min age
1 Year
Max age
Healthy volunteers
No
Inclusion Criteria: * -Presenting a complicated vascular anomalies vascular anomalies with the following characteristics: 1. Male and female; 2. Between 1 and 18 years of age; 3. Complicated vascular anomalies vascular anomalies diagnosis was confirmed by local investigators and by consensus of our multidisciplinary vascular anomaly group at the West China Hospital of Sichuan University based on: Biopsy; Compatible MRI findings; History and clinical features. Exclusion Criteria: 1. Patients have allergy or contraindication to MEK inhibitor 2. Exposure to chemotherapy, embolization, corticosteroids, propranolol, sclerotherapy or any other investigational agents within 1 weeks before enrolment on study; 3. Patients had a history of a major surgery within 2 weeks before enrollment; 4. Any known evidence of significant local or systemic uncontrolled infection, defined as receiving intravenous antibiotics at the time of enrollment; 5. Impairment of gastrointestinal function or chronic gastrointestinal disease that may significantly alter the absorption of trametinib. 6. Concurrent severe and/or uncontrolled medical diseases that could compromise participation in the study (e.g. uncontrolled diabetes, uncontrolled hypertension, severe malnutrition, chronic liver or renal disease, active upper gastrointestinal tract ulceration). 7. Patients with inadequate liver function: Total bilirubin higher than or equal to 1.5 × the upper limit of the normal (ULN) for age and alanine aminotransferase and aspartate aminotransferase higher than or equal to 2.5 × the ULN for age. 8. Patients with inadequate renal function: 0-5 years of age maximum serum creatinine (mg/dL) of 0.8; 6-10 years of age maximum serum creatinine (mg/dL) of 1.0; 11-14 years of age maximum serum creatinine (mg/dL) of 1.2; 9. Adequate bone marrow function: Absolute neutrophil count lower than 1 × 109/L; 10. History of a malignancy within 5 years; 11. HIV infection or known immunodeficiency; 12. Patients with an inability to participate in or follow-up during the study treatment and assessment plan; 13. Inability to give informed consent.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
West China Hospital of Sichuan University Chengdu Sichuan

More West China Hospital trials in China

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07072403 on ClinicalTrials.gov ↗ ← All trials in China