Selinexor in Maintenance Therapy After Systemic Therapy for Participants With p53 Wild-Type, Advanced or Recurrent Endometrial Carcinoma
Purpose
The purpose of this study is to evaluate the efficacy and safety of selinexor as a maintenance treatment in patients with p53 wt endometrial carcinoma (EC), who have achieved a partial response (PR) or complete response (CR) (per Response Evaluation Criteria in Solid Tumors version 1.1 [RECIST v 1.1]) after completing at least 12 weeks of platinum-based therapy. A total of 276 participants will be enrolled in the study and randomized in a 1:1 ratio to maintenance therapy with either selinexor or placebo.
Condition
- Endometrial Cancer
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
Patients must meet all of the following inclusion criteria in order to be eligible to participate in this study: - Adults (Aged ≥ 18 years) - Histologically confirmed endometrial cancer (endometrioid, serous, undifferentiated, or carcinosarcoma sub-types) that is TP53 wild type by central NGSHistologically confirmed EC including endometrioid, serous, undifferentiated, and carcinosarcoma - Must have completed at least 12 weeks of platinum-based chemotherapy (with or without immune checkpoint inhibitors), with a confirmed partial or complete response according to RECIST v1.1 - Must be able to initiate C1D1 within 3-8 weeks after last platinum dose - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 - Adequate bone marrow function and organ function
Exclusion Criteria
Patients meeting any of the following exclusion criteria are not eligible to participate in this study: - Uterine sarcomas, clear cell or small cell carcinoma with neuroendocrine differentiation - Palliative radiotherapy administered within 14 days of intended C1D1 - Any gastrointestinal dysfunction that could interfere with the absorption of oral study therapy - Serious psychiatric or medical conditions that could interfere with study participation or would make study involvement unreasonably hazardous - Previous treatment with an XPO1 inhibitor - Stable disease or disease progression after platinum-based chemotherapy - Pregnancy, breastfeeding, or other legal/ethical restrictions to trial participation - Known dMMR/MSI-H EC tumors that are medically eligible to receive an immune checkpoint inhibitor
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
- Masking Description
- Double blind placebo-controlled study
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Selinexor |
Participants will receive a fixed dose of selinexor 60 milligrams (mg) oral tablets once weekly (QW) on Days 1, 8, 15, and 22 of each 28-day cycle. |
|
|
Placebo Comparator Placebo |
Participants will receive matching placebo for selinexor oral tablets QW on Days 1, 8, 15, and 22 of each 28-day cycle. |
|
Recruiting Locations
Birmingham 4049979, Alabama 4829764 35205
Little Rock 4119403, Arkansas 4099753 72205
Duarte 5344147, California 5332921 91010
Irvine 5359777, California 5332921 92618
Los Angeles 5368361, California 5332921 90095
Los Angeles 5368361, California 5332921 90806
Palo Alto 5380748, California 5332921 94304
San Francisco 5391959, California 5332921 94109
Fort Lauderdale 4155966, Florida 4155751 33316
Miami Beach 4164143, Florida 4155751 33140
Orlando 4167147, Florida 4155751 32804
Atlanta 4180439, Georgia 4197000 30303
Atlanta 4180439, Georgia 4197000 30322
Augusta 4180531, Georgia 4197000 30912
Gainesville 4196586, Georgia 4197000 30501
Arlington Heights 4883555, Illinois 4896861 60005
Evanston 4891382, Illinois 4896861 60201
Dyer 4919820, Indiana 4921868 46311
Indianapolis 4259418, Indiana 4921868 46260
South Bend 4926563, Indiana 4921868 46601
Iowa City 4862034, Iowa 4862182 52242
Baton Rouge 4315588, Louisiana 4331987 70808
New Orleans 4335045, Louisiana 4331987 70119
Shreveport 4341513, Louisiana 4331987 71133
Boston 4930956, Massachusetts 6254926 02111
Detroit 4990729, Michigan 5001836 48201
Minneapolis 5037649, Minnesota 5037779 55404
Minneapolis 5037649, Minnesota 5037779 55455
Jackson 4431410, Mississippi 4436296 39216
Kansas City 4393217, Missouri 4398678 64132
Billings 5640350, Montana 5667009 59101
Las Vegas 5506956, Nevada 5509151 89106
Reno 5511077, Nevada 5509151 89511
Albany 5106834, New York 5128638 12208
Mineola 5127134, New York 5128638 11501
New Hyde Park 5128514, New York 5128638 11042
New York 5128581, New York 5128638 10016
New York 5128581, New York 5128638 10075
Rego Park 5133640, New York 5128638 11374
Rochester 5134086, New York 5128638 14642
Charlotte 4460243, North Carolina 4482348 28209
Durham 4464368, North Carolina 4482348 27710
Cincinnati 4508722, Ohio 5165418 45219
Cleveland 5150529, Ohio 5165418 44109
Columbus 4509177, Ohio 5165418 43219
Sylvania 5173572, Ohio 5165418 43560
Oklahoma City 4544349, Oklahoma 4544379 73104
Tulsa 4553433, Oklahoma 4544379 74146
Eugene 5725846, Oregon 5744337 97401
Portland 5746545, Oregon 5744337 97213
Langhorne 5197140, Pennsylvania 6254927 19047
Pittsburgh 5206379, Pennsylvania 6254927 15224
Sioux Falls 5231851, South Dakota 5769223 57105
Knoxville 4634946, Tennessee 4662168 37920
Memphis 4641239, Tennessee 4662168 38103
Austin 4671654, Texas 4736286 78731
Dallas 4684888, Texas 4736286 75235
Dallas 4684888, Texas 4736286 75246
Dallas 4684888, Texas 4736286 75390
Houston 4699066, Texas 4736286 77030
San Antonio 4726206, Texas 4736286 78240
The Woodlands 4736476, Texas 4736286 77380
Tyler 4738214, Texas 4736286 75702
Salt Lake City 5780993, Utah 5549030 84112
Charlottesville 4752031, Virginia 6254928 22908
Madison 5261457, Wisconsin 5279468 53792
More Details
- NCT ID
- NCT05611931
- Status
- Recruiting
- Sponsor
- Karyopharm Therapeutics Inc