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, Alabama 35205
Little Rock, Arkansas 72205
Duarte, California 91010
Los Alamitos, California 90720
Los Angeles, California 90095
Los Angeles, California 90806
Palo Alto, California 94304
San Francisco, California 94109
Fort Lauderdale, Florida 33316
Miami Beach, Florida 33140
Atlanta, Georgia 30322
Augusta, Georgia 30912
Gainesville, Georgia 30501
Arlington Heights, Illinois 60005
Evanston, Illinois 60201
Dyer, Indiana 46311
Indianapolis, Indiana 46260
South Bend, Indiana 46601
Baton Rouge, Louisiana 70808
New Orleans, Louisiana 70119
Boston, Massachusetts 02111
Detroit, Michigan 48201
Minneapolis, Minnesota 55404
Jackson, Mississippi 39216
Kansas City, Missouri 64132
Billings, Montana 59101
Neptune City, New Jersey 07753
Albany, New York 12208
Mineola, New York 11501
New Hyde Park, New York 11042
New York, New York 10016
Rego Park, New York 11374
Rochester, New York 14642
Charlotte, North Carolina 28209
Cincinnati, Ohio 45219
Columbus, Ohio 43219
Oklahoma City, Oklahoma 73104
Tulsa, Oklahoma 74146
Portland, Oregon 97213
Langhorne, Pennsylvania 19047
Pittsburgh, Pennsylvania 15213
Pittsburgh, Pennsylvania 15224
Knoxville, Tennessee 37920
Memphis, Tennessee 38103
Austin, Texas 78731
Dallas, Texas 75235
Dallas, Texas 75246
Dallas, Texas 75390
The Woodlands, Texas 77380
Tyler, Texas 75702
Charlottesville, Virginia 22908
Seattle, Washington 98104
Madison, Wisconsin 53792
More Details
- NCT ID
- NCT05611931
- Status
- Recruiting
- Sponsor
- Karyopharm Therapeutics Inc