NCT00411619 · STUDY IN CONTEXT

Everolimus (RAD001) Therapy of Giant Cell Astrocytoma in Patients With Tuberous Sclerosis Complex

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

Number With Observed Adverse Side Effects

Source null

→

secondary · POSTED

Overall Reduction in SEGA Tumor Volume.

Source null

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-central-nervous-system-tumors
nct id: NCT00411619
trial label: Everolimus (RAD001) Therapy of Giant Cell Astrocytoma in Patients With Tuberous Sclerosis Complex
applicability: narrower
applicability note: Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z
provenance class: regulator-cited
discovery note: Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
outcome Count: 2
harms Count: 1
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-central-nervous-system-tumors
nct id
NCT00411619
outcome key
om-0000
source section id
NCT00411619-om-0000
source outcome index
0
endpoint
Number With Observed Adverse Side Effects
endpoint definition
Number With Observed Adverse Side Effects
time origin
During the entire study
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-central-nervous-system-tumors
nct id
NCT00411619
outcome key
om-0001
source section id
NCT00411619-om-0001
source outcome index
1
endpoint
Overall Reduction in SEGA Tumor Volume.
endpoint definition
Overall Reduction in SEGA Tumor Volume.
time origin
During the entire study
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

arms

release id
clinical-indications-draft-1
disease state id
ds-central-nervous-system-tumors
nct id
NCT00411619
outcome key
om-0000
arm key
OG000
arm label
Everolimus
regimen
This was a non-randomized, open-label, single arm study; all patients in the study received treatment with everolimus. The initial starting dose was to be 3.0 mg/m2/day taken either daily or every other day with titration to achieve target trough concentrations of 5 to 15 ng/mL, subject to tolerability. Study drug was self-administered orally (or administered by a caregiver) at the same time each day.
analyzed count
28
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00411619-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-central-nervous-system-tumors
nct id
NCT00411619
outcome key
om-0001
arm key
OG000
arm label
Everolimus
regimen
This was a non-randomized, open-label, single arm study; all patients in the study received treatment with everolimus.
analyzed count
26
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00411619-om-0001#groups/OG000

harms

release id
clinical-indications-draft-1
disease state id
ds-central-nervous-system-tumors
nct id
NCT00411619
harm key
EG000
source section id
NCT00411619-ae
event group key
EG000
event group label
Everolimus
serious affected
9
serious at risk
28
other affected
28
other at risk
28
frequency threshold
5
collection period
Adverse events were collected throughout the course of the study, which was open for seven years.
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

quality of life

setting source links

Preserved source evidence · Not medical advice