Study of LY3023414 for the Treatment of Recurrent or Persistent Endometrial Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02549989|
Recruitment Status : Active, not recruiting
First Posted : September 15, 2015
Last Update Posted : June 17, 2020
|Condition or disease||Intervention/treatment||Phase|
|Endometrial Cancer Recurrent Endometrial Cancer||Drug: LY3023414||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||31 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Single-Arm, Open-Label, Phase II Study of LY3023414 for the Treatment of Recurrent or Persistent Endometrial Cancer|
|Actual Study Start Date :||September 2015|
|Estimated Primary Completion Date :||September 2021|
|Estimated Study Completion Date :||September 2021|
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.
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) [ Time Frame: ≥12 weeks from the start of treatment ]defined as the percentage of patients with complete response (CR) + partial response (PR) + stable disease (SD) ≥12 weeks from the start of treatment.
- overall response rate [ Time Frame: 1 year ]determined by RECIST 1.1.
- progression free survival (PFS) [ Time Frame: 1 year ]defined as the duration of time from start of treatment to time of recurrence, progression, or death due to any cause, whichever occurs first.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02549989
|United States, New Jersey|
|Memorial Sloan Kettering at Basking Ridge|
|Basking Ridge, New Jersey, United States, 07920|
|Memorial Sloan Kettering Monmouth|
|Middletown, New Jersey, United States, 07748|
|United States, New York|
|Memorial Sloan Kettering Commack|
|Commack, New York, United States, 11725|
|Memorial Sloan Kettering Westchester|
|Harrison, New York, United States, 10604|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10065|
|Memorial Sloan Kettering Nassau|
|Uniondale, New York, United States, 11553|
|Principal Investigator:||Vicky Makker, MD||Memorial Sloan Kettering Cancer Center|