Trial Outcomes & Findings for Study of LY3023414 for the Treatment of Recurrent or Persistent Endometrial Cancer (NCT NCT02549989)
NCT ID: NCT02549989
Last Updated: 2023-02-22
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
28 participants
Primary outcome timeframe
12 weeks from baseline up to a year
Results posted on
2023-02-22
Participant Flow
Participant milestones
| Measure |
LY3023414
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
|
|---|---|
|
Overall Study
STARTED
|
28
|
|
Overall Study
COMPLETED
|
1
|
|
Overall Study
NOT COMPLETED
|
27
|
Reasons for withdrawal
| Measure |
LY3023414
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
|
|---|---|
|
Overall Study
Adverse Event
|
4
|
|
Overall Study
Death
|
1
|
|
Overall Study
Lack of Efficacy
|
19
|
|
Overall Study
Withdrawal by Subject
|
3
|
Baseline Characteristics
Study of LY3023414 for the Treatment of Recurrent or Persistent Endometrial Cancer
Baseline characteristics by cohort
| Measure |
LY3023414
n=28 Participants
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
|
|---|---|
|
Age, Continuous
|
65 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
26 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
28 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeks from baseline up to a yeardefined 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.
Outcome measures
| Measure |
LY3023414
n=25 Participants
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
|
|---|---|
|
Clinical Benefit Rate (CBR)
Participants with Clinical Benefit Rate (CR+PR+SD)
|
7 Participants
|
|
Clinical Benefit Rate (CBR)
Participants without CBR
|
18 Participants
|
PRIMARY outcome
Timeframe: 1 yeardetermined by RECIST 1.1.
Outcome measures
| Measure |
LY3023414
n=28 Participants
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
|
|---|---|
|
Overall Response Rate
|
16 percentage of participants
Interval 7.0 to 100.0
|
SECONDARY outcome
Timeframe: 1 yearDefined 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
Outcome measures
| Measure |
LY3023414
n=28 Participants
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
|
|---|---|
|
Progression Free Survival (PFS)
|
2.5 months
Interval 1.2 to 3.0
|
SECONDARY outcome
Timeframe: 1 yearTo 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.
Outcome measures
| Measure |
LY3023414
n=28 Participants
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
|
|---|---|
|
Duration of Response (DOR)
|
4.2 months
Interval 1.4 to 9.6
|
SECONDARY outcome
Timeframe: 1 yearTo 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.
Outcome measures
| Measure |
LY3023414
n=28 Participants
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
|
|---|---|
|
Number of Participants Assessed for AE's With PI3K Activated Recurrent/Persistent Endometrial Cancer
|
28 Participants
|
Adverse Events
LY3023414
Serious events: 7 serious events
Other events: 27 other events
Deaths: 16 deaths
Serious adverse events
| Measure |
LY3023414
n=28 participants at risk
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
|
|---|---|
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Investigations
Alanine aminotransferase increased
|
3.6%
1/28 • 1 year
|
|
Immune system disorders
Allergic reaction
|
3.6%
1/28 • 1 year
|
|
Investigations
Aspartate aminotransferase increased
|
3.6%
1/28 • 1 year
|
|
Investigations
Blood bilirubin increased
|
3.6%
1/28 • 1 year
|
|
Investigations
Cardiac troponin I increased
|
3.6%
1/28 • 1 year
|
|
General disorders
Chills
|
3.6%
1/28 • 1 year
|
|
Investigations
Creatinine increased
|
3.6%
1/28 • 1 year
|
|
General disorders
Death NOS
|
3.6%
1/28 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
3.6%
1/28 • 1 year
|
|
Injury, poisoning and procedural complications
Fall
|
3.6%
1/28 • 1 year
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
3.6%
1/28 • 1 year
|
|
General disorders
Fever
|
3.6%
1/28 • 1 year
|
|
Metabolism and nutrition disorders
Hypokalemia
|
3.6%
1/28 • 1 year
|
|
Metabolism and nutrition disorders
Hyponatremia
|
7.1%
2/28 • 1 year
|
|
Gastrointestinal disorders
Mucositis oral
|
3.6%
1/28 • 1 year
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
7.1%
2/28 • 1 year
|
|
Infections and infestations
Sepsis
|
3.6%
1/28 • 1 year
|
|
Infections and infestations
Urinary tract infection
|
3.6%
1/28 • 1 year
|
Other adverse events
| Measure |
LY3023414
n=28 participants at risk
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
|
|---|---|
|
Investigations
Alanine aminotransferase increased
|
60.7%
17/28 • 1 year
|
|
Investigations
Alkaline phosphatase increased
|
46.4%
13/28 • 1 year
|
|
Blood and lymphatic system disorders
Anemia
|
89.3%
25/28 • 1 year
|
|
Investigations
Aspartate aminotransferase increased
|
42.9%
12/28 • 1 year
|
|
Gastrointestinal disorders
Constipation
|
28.6%
8/28 • 1 year
|
|
Investigations
Creatinine increased
|
21.4%
6/28 • 1 year
|
|
General disorders
Fatigue
|
21.4%
6/28 • 1 year
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
85.7%
24/28 • 1 year
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
71.4%
20/28 • 1 year
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
39.3%
11/28 • 1 year
|
|
Metabolism and nutrition disorders
Hypokalemia
|
50.0%
14/28 • 1 year
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
50.0%
14/28 • 1 year
|
|
Metabolism and nutrition disorders
Hyponatremia
|
42.9%
12/28 • 1 year
|
|
Investigations
Lymphocyte count decreased
|
75.0%
21/28 • 1 year
|
|
Gastrointestinal disorders
Nausea
|
46.4%
13/28 • 1 year
|
|
Investigations
Platelet count decreased
|
57.1%
16/28 • 1 year
|
|
Investigations
White blood cell decreased
|
60.7%
17/28 • 1 year
|
Additional Information
Dr. Vicky Makker, MD
Memorial Sloan Kettering Cancer Center
Phone: 646-888-4224
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place