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| Name | Class |
|---|---|
| Eli Lilly and Company | INDUSTRY |
The purpose of this study is to determine the effectiveness of LY3023414 in treating the participants type of cancer and to determine the types and severity of side effects caused by treatment with LY3023414.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY3023414 | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3023414 | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Benefit Rate (CBR) | 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. | 12 weeks from baseline up to a year |
| Overall Response Rate | determined by RECIST 1.1. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) | 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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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vicky Makker, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan Kettering at Basking Ridge | Basking Ridge | New Jersey | 07920 | United States | ||
| Memorial Sloan Kettering Monmouth |
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| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Clinical Benefit Rate (CBR) | 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. | Posted | Count of Participants | Participants | 12 weeks from baseline up to a year |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Alanine aminotransferase increased | Investigations | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Alanine aminotransferase increased | Investigations | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Vicky Makker, MD | Memorial Sloan Kettering Cancer Center | 646-888-4224 | makkerv@mskcc.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 16, 2020 | Dec 9, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D016889 | Endometrial Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| C000621566 | LY3023414 |
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|
| 1 year |
| Duration of Response (DOR) | 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. | 1 year |
| Number of Participants Assessed for AE's With PI3K Activated Recurrent/Persistent Endometrial Cancer | 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. | 1 year |
| Middletown |
| New Jersey |
| 07748 |
| United States |
| Memorial Sloan Kettering Commack | Commack | New York | 11725 | United States |
| Memorial Sloan Kettering Westchester | Harrison | New York | 10604 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| Memorial Sloan Kettering Nassau | Uniondale | New York | 11553 | United States |
| Withdrawal by Subject |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
| Primary | Overall Response Rate | determined by RECIST 1.1. | Posted | Mean | 90% Confidence Interval | percentage of participants | 1 year |
|
|
|
| Secondary | Progression Free Survival (PFS) | 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 | Posted | Median | 95% Confidence Interval | months | 1 year |
|
|
|
| Secondary | Duration of Response (DOR) | 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. | Posted | Mean | 95% Confidence Interval | months | 1 year |
|
|
|
| Secondary | Number of Participants Assessed for AE's With PI3K Activated Recurrent/Persistent Endometrial Cancer | 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. | Posted | Count of Participants | Participants | 1 year |
|
|
|
| 16 |
| 28 |
| 7 |
| 28 |
| 27 |
| 28 |
| Allergic reaction | Immune system disorders | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | Systematic Assessment |
|
| Cardiac troponin I increased | Investigations | Systematic Assessment |
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| Chills | General disorders | Systematic Assessment |
|
| Creatinine increased | Investigations | Systematic Assessment |
|
| Death NOS | General disorders | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | Systematic Assessment |
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| Febrile neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
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| Fever | General disorders | Systematic Assessment |
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| Hypokalemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Hyponatremia | Metabolism and nutrition disorders | Systematic Assessment |
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| Mucositis oral | Gastrointestinal disorders | Systematic Assessment |
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| Rash maculo-papular | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Sepsis | Infections and infestations | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | Systematic Assessment |
|
| Alkaline phosphatase increased | Investigations | Systematic Assessment |
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| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
| Creatinine increased | Investigations | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
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| Hyperglycemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Hypoalbuminemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hypocalcemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Hypokalemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hypomagnesemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hyponatremia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Lymphocyte count decreased | Investigations | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Platelet count decreased | Investigations | Systematic Assessment |
|
| White blood cell decreased | Investigations | Systematic Assessment |
|
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| D009369 |
| Neoplasms |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |