Study of LY3023414 for the Treatment of Recurrent or Persistent Endometrial Cancer

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

defined as the percentage of patients with complete response (CR) + partial response (PR) + stable disease (SD) ≥12 weeks from the start of treatment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

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primary · POSTED

determined by RECIST 1.1.

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secondary · POSTED

Defined as the duration of time from start of treatment to time of recurrence, progression, or death due to any cause, whichever occurs first. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions

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secondary · POSTED

To determine the duration of response (DOR) of LY3023414 therapy, defined as the time from which measurement criteria are met for CR or PR (whichever status is recorded first) until the first date of documented disease progression.

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secondary · POSTED

To assess the safety profile and tolerability of LY3023414 therapy in patients with PI3K activated recurrent/persistent endometrial cancer using the e current version of the National Cancer Institute Common Terminology Criteria for Adverse Events, which was version 4.03.

Source null

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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-keytruda-qlex-1191efca
nct id: NCT02549989
trial label: Study of LY3023414 for the Treatment of Recurrent or Persistent Endometrial Cancer
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: 5
harms Count: 1
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-endometrial-cancer-keytruda-qlex-1191efca
nct id
NCT02549989
outcome key
om-0000
source section id
NCT02549989-om-0000
source outcome index
0
endpoint
Clinical Benefit Rate (CBR)
endpoint definition
defined as the percentage of patients with complete response (CR) + partial response (PR) + stable disease (SD) ≥12 weeks from the start of treatment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
time origin
12 weeks from baseline up to a year
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-endometrial-cancer-keytruda-qlex-1191efca
nct id
NCT02549989
outcome key
om-0001
source section id
NCT02549989-om-0001
source outcome index
1
endpoint
Overall Response Rate
endpoint definition
determined by RECIST 1.1.
time origin
1 year
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-endometrial-cancer-keytruda-qlex-1191efca
nct id
NCT02549989
outcome key
om-0002
source section id
NCT02549989-om-0002
source outcome index
2
endpoint
Progression Free Survival (PFS)
endpoint definition
Defined as the duration of time from start of treatment to time of recurrence, progression, or death due to any cause, whichever occurs first. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
time origin
1 year
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
release id
clinical-indications-draft-1
disease state id
ds-endometrial-cancer-keytruda-qlex-1191efca
nct id
NCT02549989
outcome key
om-0003
source section id
NCT02549989-om-0003
source outcome index
3
endpoint
Duration of Response (DOR)
endpoint definition
To determine the duration of response (DOR) of LY3023414 therapy, defined as the time from which measurement criteria are met for CR or PR (whichever status is recorded first) until the first date of documented disease progression.
time origin
1 year
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
release id
clinical-indications-draft-1
disease state id
ds-endometrial-cancer-keytruda-qlex-1191efca
nct id
NCT02549989
outcome key
om-0004
source section id
NCT02549989-om-0004
source outcome index
4
endpoint
Number of Participants Assessed for AE's With PI3K Activated Recurrent/Persistent Endometrial Cancer
endpoint definition
To assess the safety profile and tolerability of LY3023414 therapy in patients with PI3K activated recurrent/persistent endometrial cancer using the e current version of the National Cancer Institute Common Terminology Criteria for Adverse Events, which was version 4.03.
time origin
1 year
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-endometrial-cancer-keytruda-qlex-1191efca
nct id
NCT02549989
outcome key
om-0000
arm key
OG000
arm label
LY3023414
regimen
This is an MSKCC investigator-initiated, single-center, non-randomized, open-label, phase II study to evaluate the activity of LY3023414 dosed at the RP2D of 200 mg orally twice daily in patients with recurrent or persistent endometrial cancer. LY3023414: Enrolled patients will take LY3023414 200 mg orally twice a day. Each cycle will be 21 days in duration. Patients will receive study treatment until disease progression, intolerable toxicity, elective withdrawal from the study, study completion, or study termination
analyzed count
25
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02549989-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-endometrial-cancer-keytruda-qlex-1191efca
nct id
NCT02549989
outcome key
om-0001
arm key
OG000
arm label
LY3023414
regimen
This is an MSKCC investigator-initiated, single-center, non-randomized, open-label, phase II study to evaluate the activity of LY3023414 dosed at the RP2D of 200 mg orally twice daily in patients with recurrent or persistent endometrial cancer. LY3023414: Enrolled patients will take LY3023414 200 mg orally twice a day. Each cycle will be 21 days in duration. Patients will receive study treatment until disease progression, intolerable toxicity, elective withdrawal from the study, study completion, or study termination
analyzed count
28
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02549989-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-endometrial-cancer-keytruda-qlex-1191efca
nct id
NCT02549989
outcome key
om-0002
arm key
OG000
arm label
LY3023414
regimen
This is an MSKCC investigator-initiated, single-center, non-randomized, open-label, phase II study to evaluate the activity of LY3023414 dosed at the RP2D of 200 mg orally twice daily in patients with recurrent or persistent endometrial cancer. LY3023414: Enrolled patients will take LY3023414 200 mg orally twice a day. Each cycle will be 21 days in duration. Patients will receive study treatment until disease progression, intolerable toxicity, elective withdrawal from the study, study completion, or study termination
analyzed count
28
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02549989-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-endometrial-cancer-keytruda-qlex-1191efca
nct id
NCT02549989
outcome key
om-0003
arm key
OG000
arm label
LY3023414
regimen
This is an MSKCC investigator-initiated, single-center, non-randomized, open-label, phase II study to evaluate the activity of LY3023414 dosed at the RP2D of 200 mg orally twice daily in patients with recurrent or persistent endometrial cancer. LY3023414: Enrolled patients will take LY3023414 200 mg orally twice a day. Each cycle will be 21 days in duration. Patients will receive study treatment until disease progression, intolerable toxicity, elective withdrawal from the study, study completion, or study termination
analyzed count
28
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02549989-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-endometrial-cancer-keytruda-qlex-1191efca
nct id
NCT02549989
outcome key
om-0004
arm key
OG000
arm label
LY3023414
regimen
This is an MSKCC investigator-initiated, single-center, non-randomized, open-label, phase II study to evaluate the activity of LY3023414 dosed at the RP2D of 200 mg orally twice daily in patients with recurrent or persistent endometrial cancer. LY3023414: Enrolled patients will take LY3023414 200 mg orally twice a day. Each cycle will be 21 days in duration. Patients will receive study treatment until disease progression, intolerable toxicity, elective withdrawal from the study, study completion, or study termination
analyzed count
28
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02549989-om-0004#groups/OG000

harms

release id
clinical-indications-draft-1
disease state id
ds-endometrial-cancer-keytruda-qlex-1191efca
nct id
NCT02549989
harm key
EG000
source section id
NCT02549989-ae
event group key
EG000
event group label
LY3023414
serious affected
7
serious at risk
28
other affected
27
other at risk
28
frequency threshold
5
collection period
1 year
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