Status:
COMPLETED
Efficacy and Safety of the Mammalian Target of Rapamycin (mTor Rapamycin) Inhibitor in Vascular Malformations
Lead Sponsor:
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Conditions:
Cardiovascular Abnormalities
Eligibility:
All Genders
Up to 70 years
Phase:
PHASE3
Brief Summary
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 investi...
Detailed Description
The complex vascular malformations induce chronical pains and organic dysfunctions causing significant morbidity and mortality. Therefore, the investigators need to establish guidelines in order to tr...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2016
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT01811667
Start Date
May 1 2012
End Date
January 1 2016
Last Update
April 14 2016
Active Locations (1)
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1
Cliniques universitaires Saint-Luc
Brussels, Brussels Capital, Belgium, 1200