|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
19 February 2015 |
|
Main ID: |
NCT00457964 |
|
Date of registration:
|
06/04/2007 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
RAD001 Therapy of Angiomyolipomata in Patients With TS Complex and Sporadic LAM
|
|
Scientific title:
|
RAD001 Therapy of Angiomyolipomata in Patients With Tuberous Sclerosis Complex and Sporadic Lymphangioleiomyomatosis |
|
Date of first enrolment:
|
August 2005 |
|
Target sample size:
|
36 |
|
Recruitment status: |
Completed |
|
URL:
|
http://clinicaltrials.gov/show/NCT00457964 |
|
Study type:
|
Interventional |
|
Study design:
|
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
|
|
Phase:
|
Phase 1/Phase 2
|
|
|
Countries of recruitment
|
|
United States
| | | | | | | |
|
Contacts
|
|
Name:
|
John J. Bissler, M.D. |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
LaBonheur Children's Hospital |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Diagnosed with angiomyolipomas and have either Tuberous Sclerosis Complex or
lymphangioleiomyomatosis
- Angiomyolipoma one centimeter or greater in largest diameter
- Between the ages of 18 and 65 years old.
- If female, documentation of negative pregnancy test prior to enrollment and, where
applicable, use of appropriate non-estrogen containing birth control contraceptive
regimen while on study.
- Adequate renal function (creatinine < 3 mg/dl)
Exclusion Criteria:
- Pregnant or lactating women
- Continuous requirement for supplemental oxygen
- Surgery within past 2 months
- Use of an investigational drug within last 30 days.
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Lymphangioleiomyomatosis
|
|
Tuberous Sclerosis
|
|
Intervention(s)
|
|
Drug: RAD001
|
|
Primary Outcome(s)
|
|
Patients will be considered responders if their angiomyolipoma volume decreases by thirty percent or more from baseline
[Time Frame: 12 months]
|
|
Secondary ID(s)
|
|
CCHMC IRB #2008-0812(04-07-22)
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|