CI

At a glance

ClinicalIndex Comparison Record
Phase 3Recruiting· 250 target
Drug / intervention
Sirolimusdrug
Likely dose
Not stated in record
Key inclusion· 4
  • ✓Complex vascular anomalies refractory to standard care (medical treatment, surgical resection, sclerotherapy/embolization)
  • ✓Adequate medullary (bone marrow) function with hemoglobin >10 g/dL, neutrophils >1500/mm³, platelets >100,000/mm³
  • ✓Able to sign informed consent
  • ✓Women of childbearing potential must use contraception during study
Key exclusion· 7
  • ✕Impaired cardiac function or clinically significant cardiac diseases including unstable angina, arrhythmia, myocardial infarction within 6 months, congestive heart failure (NYHA III-IV), cardiomyopathy, QT prolongation or Torsades de Pointes
  • ✕GI impairment or disease significantly altering sirolimus absorption (ulcerative diseases, uncontrolled nausea/vomiting/diarrhea ≥Grade 2, malabsorption, small bowel resection)
  • ✕Known hypersensitivity to drugs or metabolites from similar classes as study treatment
  • ✕Other severe/uncontrolled medical conditions (acute/chronic pancreatitis, liver cirrhosis, active chronic hepatitis, severely impaired lung function ≤50% predicted or O2 saturation ≤88% at rest)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02638389
NCT02638389Phase 3RecruitingUpdate OverdueUpdated 40mo ago · Completion was 15mo ago
Enrollment Stalled
Long Recruiting
Update Overdue
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Phase III Multicentric Study Evaluating the Efficacy and Safety of Sirolimus in Vascular Anomalies That Are Refractory to Standard Care

Cliniques universitaires Saint-Luc- Université Catholique de Louvain·interventional·Posted Dec 23, 2015·Updated Feb 24, 2023

In Brief

A Phase 3 clinical trial evaluating Sirolimus for Vascular Malformations. Currently recruiting, targeting 250 participants across 3 sites in 3 countries.

Signals

Enrollment appears stalled

Detailed Summary

The phosphatidylinositol 3-kinase (PI3Kinase)/Protein Kinase B (AKT)/mammalian target of rapamycin (mTor) pathway plays a role on the development and the venous/lymphatic vascular organisations. The investigators want to study the efficacy and the safety of Rapamycin, an mTor inhibitor.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsVascular Malformations
CountriesBelgium, France, Germany
Collaborators--

Timeline

Phase 3Recruiting
201620172018201920202021202220232024202520262027202820292030
First PostedDec 23, 2015
Enrollment StartJan 25, 2016
Primary CompletionApr 1, 2025
Study CompletionApr 1, 2030
TodayJul 2, 2026
Enrollment to primary: 9.2 yearsPosted 10.5 years ago

Interventions

Sirolimusdrug

evaluate the efficacy and safety of sirolimus in these patients