A Phase II, Single-Arm Study of RAD001 (Everolimus), Letrozole, and Metformin in Patients With Advanced or Recurrent Endometrial Carcinoma

Draft scope assessment: unclear. Attached because the study's own record describes recurrent disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. 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

The proportion of patients demonstrating a clinical benefit (CBR) complete response + partial response + stable disease rates) based on RECIST v1.1.

54 participants were evaluable

→

secondary · POSTED

Progression-Free Survival (PFS)

54 participants were evaluable

→

secondary · POSTED

To determine the frequency and severity of toxicities associated with RAD001, letrozole, and metformin in this cohort of patients.

59 patients who had at least one dose of treatment and had a follow up evaluation for side effects

→

secondary · POSTED

Number of Mutations Detected in Women With Endometrial Cancer

There were 9 patients who had mutational analysis on their primary tumor in addition to the research biopsy performed as part of the study.

→

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-endometrial-cancer-jemperli-9afc2dc5
nct id: NCT01797523
trial label: A Phase II, Single-Arm Study of RAD001 (Everolimus), Letrozole, and Metformin in Patients With Advanced or Recurrent Endometrial Carcinoma
applicability: unclear
applicability note: Attached because the study's own record describes recurrent disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
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: 4
harms Count: 1
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-endometrial-cancer-jemperli-9afc2dc5
nct id
NCT01797523
outcome key
om-0000
source section id
NCT01797523-om-0000
source outcome index
0
endpoint
Clinical Benefit (CBR) Complete Response + Partial Response + Stable Disease Rates) Based on RECIST v1.1.
endpoint definition
The proportion of patients demonstrating a clinical benefit (CBR) complete response + partial response + stable disease rates) based on RECIST v1.1.
time origin
93 months
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
54 participants were evaluable
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-endometrial-cancer-jemperli-9afc2dc5
nct id
NCT01797523
outcome key
om-0001
source section id
NCT01797523-om-0001
source outcome index
1
endpoint
Progression-Free Survival (PFS)
endpoint definition
Progression-Free Survival (PFS)
time origin
93 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
54 participants were evaluable
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-endometrial-cancer-jemperli-9afc2dc5
nct id
NCT01797523
outcome key
om-0002
source section id
NCT01797523-om-0002
source outcome index
2
endpoint
Percentage of Participants With Toxicities Associated With RAD001, Letrozole, and Metformin
endpoint definition
To determine the frequency and severity of toxicities associated with RAD001, letrozole, and metformin in this cohort of patients.
time origin
93 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
59 patients who had at least one dose of treatment and had a follow up evaluation for side effects
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-endometrial-cancer-jemperli-9afc2dc5
nct id
NCT01797523
outcome key
om-0003
source section id
NCT01797523-om-0003
source outcome index
3
endpoint
Number of Mutations Detected in Women With Endometrial Cancer
endpoint definition
Number of Mutations Detected in Women With Endometrial Cancer
time origin
93 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
There were 9 patients who had mutational analysis on their primary tumor in addition to the research biopsy performed as part of the study.
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-endometrial-cancer-jemperli-9afc2dc5
nct id
NCT01797523
outcome key
om-0000
arm key
OG000
arm label
Rad-Let-Met
regimen
Everolimus 10 mg PO daily + Letrozole 2.5 mg PO daily + Metformin 500 mg PO twice daily on a 4 week schedule
analyzed count
54
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01797523-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-endometrial-cancer-jemperli-9afc2dc5
nct id
NCT01797523
outcome key
om-0001
arm key
OG000
arm label
Rad-Let-Met
regimen
Everolimus 10 mg PO daily + Letrozole 2.5 mg PO daily + Metformin 500 mg PO twice daily on a 4 week schedule
analyzed count
54
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01797523-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-endometrial-cancer-jemperli-9afc2dc5
nct id
NCT01797523
outcome key
om-0002
arm key
OG000
arm label
Rad-Let-Met
regimen
Everolimus 10 mg PO daily + Letrozole 2.5 mg PO daily + Metformin 500 mg PO twice daily on a 4 week schedule
analyzed count
59
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01797523-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-endometrial-cancer-jemperli-9afc2dc5
nct id
NCT01797523
outcome key
om-0003
arm key
OG000
arm label
Rad-Let-Met
regimen
Everolimus 10 mg PO daily + Letrozole 2.5 mg PO daily + Metformin 500 mg PO twice daily on a 4 week schedule
analyzed count
62
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01797523-om-0003#groups/OG000

harms

release id
clinical-indications-draft-1
disease state id
ds-endometrial-cancer-jemperli-9afc2dc5
nct id
NCT01797523
harm key
EG000
source section id
NCT01797523-ae
event group key
EG000
event group label
Rad-Let-Met
serious affected
6
serious at risk
62
other affected
60
other at risk
62
frequency threshold
1
collection period
93 months from October 2013 until July 2021
event definition
One participant expired unrelated to the clinical trial treatment
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