Cardiovascular Abnormalities Clinical Trial
— vasca-LMOfficial title:
Clinical Study on Efficacy and Safety of the mTor Rapamycin Inhibitor Found in the Complex Vascular Malformations
The phosphatidylinositol 3-kinase (PI3Kinase)/Protein Kinase B (AKT)/mammalian target of
rapamycin (mTor) pathway plays a role on the development and the lymphatic-vascular
organisations.
The investigators want to study the efficacy and the safety of Rapamycin, an mTor inhibitor.
Status | Completed |
Enrollment | 19 |
Est. completion date | January 2016 |
Est. primary completion date | January 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A to 70 Years |
Eligibility |
Inclusion Criteria: - Patients with complex vascular abnormalities to be threat by a systemic therapy - Patients must have adequate liver function (LDL-cholesterol, triglycerides,…) - Patients must have adequate organ function: neutrophils >1500/mm³, Hb > 8,0 g et platelets> 50.000/mm³ (no platelets limits for the Kasabach Merritt syndrome) - Patients must have adequate renal function(normal creatinin depending on the age), clearance > 70 ml/min/1.73m² and Urin Protein Creatinine ratio <0.3 g. - Karnofsky or Landry > 50 Exclusion Criteria: - Dental equipments or prosthesis interfering onto a radiological examen - Other uncontrolled medical condition (uncontrolled diabetes, hypertension…) - Concomitant drugs such as inhibitors/inducers of cytochrome P450 3A4 (CYP3A4) - Immunocompromised patients, including known seropositivity for HIV - Digestive problems modifying the absorption of Rapamycin (gastric tube feeding accepted) - Pregnant or nursing (lactating) women - Prior treatment with phosphatidylinositol 3-kinase (PI3K) and/or mTOR inhibitors |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Belgium | Cliniques universitaires Saint-Luc | Brussels |
Lead Sponsor | Collaborator |
---|---|
Cliniques universitaires Saint-Luc- Université Catholique de Louvain |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time of duration of the treatment.(Efficacy) | up to 12 months | No | |
Secondary | The number of adverse events observed | With Common Toxicity Criteria for Adverse Effects version 3 | up to 12 months | Yes |
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