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← Endometrial Cancer

NCT01797523 · STUDY IN CONTEXT

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

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. 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
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
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.
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
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-endometrial-cancer
    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
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-endometrial-cancer
    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
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-endometrial-cancer
    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
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-endometrial-cancer
    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
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-endometrial-cancer
    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
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-endometrial-cancer
    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
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-endometrial-cancer
    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
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-endometrial-cancer
    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
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-endometrial-cancer
    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