Using selinexor as maintenance therapy for advanced endometrial cancer after initial treatment
A Phase 3, Randomized, Placebo-Controlled, Double-Blind, Multicenter Trial of Selinexor in Maintenance Therapy After Systemic Therapy for Patients With p53 Wild-Type, Advanced or Recurrent Endometrial Carcinoma
PHASE3 · Karyopharm Therapeutics Inc · NCT05611931
This study is testing if the drug selinexor can help people with advanced endometrial cancer stay healthier for longer after their initial treatment.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 276 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Karyopharm Therapeutics Inc (industry) |
| Drugs / interventions | chemotherapy |
| Locations | 217 sites (Birmingham, Alabama and 216 other locations) |
| Trial ID | NCT05611931 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness and safety of selinexor as a maintenance therapy for patients with advanced or recurrent endometrial carcinoma who have a p53 wild-type status. Participants must have achieved a partial or complete response after at least 12 weeks of platinum-based chemotherapy. The study will enroll 220 participants, who will be randomly assigned to receive either selinexor or a matching placebo. The goal is to determine if selinexor can prolong the benefits of initial treatment.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with histologically confirmed p53 wild-type advanced or recurrent endometrial carcinoma who have responded to prior platinum-based therapy.
Not a fit: Patients with p53 mutant endometrial carcinoma or those who have not achieved a response to prior therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new maintenance option for patients with advanced endometrial cancer, potentially improving their outcomes.
How similar studies have performed: Previous studies have shown promise with similar maintenance therapies in other cancers, but this specific approach with selinexor is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Birmingham, Alabama and 216 other locations
- The University of Alabama at Birmingham — Birmingham, Alabama, United States (RECRUITING)
- Honor Health — Phoenix, Arizona, United States (RECRUITING)
- University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States (RECRUITING)
- UC DAVIS — Davis, California, United States (RECRUITING)
- City of Hope National Medical Center — Duarte, California, United States (RECRUITING)
- Chao Family Comprehensive Cancer Center and Ambulatory Care — Irvine, California, United States (WITHDRAWN)
- City of Hope at Irvine Lennar — Irvine, California, United States (RECRUITING)
- Cancer and Blood Specialty Clinic — Los Alamitos, California, United States (RECRUITING)
- UCLA - Women's Health Clinical Research Unit — Los Angeles, California, United States (RECRUITING)
- Long Beach Memorial Medical Center — Los Angeles, California, United States (RECRUITING)
- UC Irvine — Orange, California, United States (WITHDRAWN)
- Stanford University — Palo Alto, California, United States (RECRUITING)
- California Pacific Medical Center — San Francisco, California, United States (RECRUITING)
- Highlands Ranch Hospital — Highlands Ranch, Colorado, United States (WITHDRAWN)
- University of Colorado Cancer Center — Highlands Ranch, Colorado, United States (WITHDRAWN)
- Broward Health Medical Center — Fort Lauderdale, Florida, United States (RECRUITING)
- Mount Sinai Comprehensive Cancer Center — Miami Beach, Florida, United States (RECRUITING)
- Advent Health — Orlando, Florida, United States (RECRUITING)
- Grady Hospital — Atlanta, Georgia, United States (RECRUITING)
- Emory University — Atlanta, Georgia, United States (RECRUITING)
- Georgia Cancer Center at Augusta University — Augusta, Georgia, United States (RECRUITING)
- Northeast Georgia Medical Center — Gainesville, Georgia, United States (RECRUITING)
- Illinois Cancer Specialists — Arlington Heights, Illinois, United States (RECRUITING)
- NorthShore University Health System — Evanston, Illinois, United States (RECRUITING)
- Northwest Cancer Center — Dyer, Indiana, United States (RECRUITING)
- Goshen Health — Goshen, Indiana, United States (RECRUITING)
- St Vincent Hospital — Indianapolis, Indiana, United States (RECRUITING)
- Memorial Hospital of South Bend — South Bend, Indiana, United States (RECRUITING)
- University of Iowa — Iowa City, Iowa, United States (RECRUITING)
- Our Lady of the Lake Hospital, Inc. — Baton Rouge, Louisiana, United States (RECRUITING)
- LSU Health Sciences Center New Orleans — New Orleans, Louisiana, United States (RECRUITING)
- Trials365, LLC — Shreveport, Louisiana, United States (RECRUITING)
- Tufts Medical Center — Boston, Massachusetts, United States (RECRUITING)
- Karmanos Cancer Institute — Detroit, Michigan, United States (RECRUITING)
- USON - Minnesota Oncology Hematology — Minneapolis, Minnesota, United States (RECRUITING)
- University of Minnesota — Minneapolis, Minnesota, United States (RECRUITING)
- St. Dominic's Gynecologic Oncology — Jackson, Mississippi, United States (RECRUITING)
- Midwest Ventures Group HCA MId America Division — Kansas City, Missouri, United States (RECRUITING)
- Washington University School of Medicine — St Louis, Missouri, United States (WITHDRAWN)
- Intermountain Health St. Vincent Regional Hospital — Billings, Montana, United States (RECRUITING)
- Women's Cancer Center of Nevada — Las Vegas, Nevada, United States (RECRUITING)
- Center Of Hope — Reno, Nevada, United States (RECRUITING)
- Hackensack Meridian Health Jersey Shore University Medical Center — Neptune City, New Jersey, United States (RECRUITING)
- Women's Cancer Care Associates, LLC — Albany, New York, United States (RECRUITING)
- NYU Langone Hospital-Long Island — Mineola, New York, United States (RECRUITING)
- Northwell Health - Zuckerberg Cancer Center — New Hyde Park, New York, United States (RECRUITING)
- Mount Sinai Chelsea — New York, New York, United States (WITHDRAWN)
- Perlmutter Cancer Center at NYU Langone Health — New York, New York, United States (RECRUITING)
- Mount Sinai — New York, New York, United States (WITHDRAWN)
- Lenox Hill Hospital — New York, New York, United States (RECRUITING)
+167 more sites — see ClinicalTrials.gov for the full list.
Study contacts
- Study coordinator: Karyopharm Medical Information
- Email: clinicaltrials@karyopharm.com
- Phone: (888) 209-9326
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Endometrial Cancer, Selinexor, KPT-330, Advanced or Recurrent Endometrial Carcinoma, XPORT-EC, ENGOT-EN20, GOG-3083, XPORT-EC-042