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CLINICAL TRIAL TO DETERMINE THE EFFICACY AND SAFETY OF RAPAMYCIN IN ANGIOMYOLIPOMAS IN PATIENTS WITH TUBEROUS SCLEROSIS


Phase 4
10 Years
N/A
Not Enrolling
Both
Angiomyolipoma

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Trial Information

CLINICAL TRIAL TO DETERMINE THE EFFICACY AND SAFETY OF RAPAMYCIN IN ANGIOMYOLIPOMAS IN PATIENTS WITH TUBEROUS SCLEROSIS


Inclusion Criteria:



Diagnosis of tuberousclerosis Angiomyolipoma >2cm age>10 years

Exclusion Criteria:

Creatinine >4 No recent AML bleeding No hepatic abnormalities (liver tests 2fold)
Hematocrit<27% Thrombocytopenia (<100.000/mm3) Leukopenia (<3000/mm3) Ischemic cardiopathy
Recent surgery (2 months prior to enrollment) Pregnancy Serum cholesterol over 7.8 mmol/l
or hypertriglyceridemia fasten(>4.6 mmol/l) non controlled with drugs malignancy in the
previous 2 years allergy to macrolides

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Angiomyolipoma volume

Outcome Description:

Measured by MRI

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Roser Torra, MD,PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fundacio Puigvert, Barcelona

Authority:

Spain: Spanish agency of medicine and health care products

Study ID:

EudraCT 2007-005978-30

NCT ID:

NCT01217125

Start Date:

October 2008

Completion Date:

May 2011

Related Keywords:

  • Angiomyolipoma
  • tuberousclerosis, angiomyolipoma, rapamycin
  • Sclerosis
  • Tuberous Sclerosis
  • Angiomyolipoma

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