Study on Selinexor as Maintenance Therapy for Advanced or Recurrent Endometrial Cancer with P53 Wild-Type
Sponsor: Karyopharm Therapeutics Inc
ClinicalTrials ID:NCT05611931
This clinical trial is testing the effectiveness and safety of the drug selinexor as a maintenance treatment for patients with advanced or recurrent endometrial cancer who have responded well to initial chemotherapy. The study involves 220 participants who will receive either selinexor or a placebo after completing at least 12 weeks of platinum-based chemotherapy.
Patient Parameters
| Parameter | Options |
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Program Overview
The aim of this study is to evaluate how well selinexor works as a maintenance treatment for patients with advanced or recurrent endometrial cancer that is P53 wild-type. Participants who have shown a partial or complete response to at least 12 weeks of platinum-based chemotherapy will be randomly assigned to receive either selinexor or a placebo. The study will include 220 participants to assess the drug's effectiveness and safety.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Have a confirmed diagnosis of endometrial cancer, including specific types like endometrioid, serous, undifferentiated, and carcinosarcoma.
- Have P53 wild-type status confirmed by specific genetic testing.
- Completed at least 12 weeks of platinum-based chemotherapy and achieved a partial or complete response.
- Have not received adjuvant or neoadjuvant therapy for Stage I-III disease.
- Have a good performance status, meaning they are fully active or have some restrictions but can still perform light work.
- Have adequate bone marrow and organ function based on recent lab tests.
- Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during the study and for 90 days after the last dose.
- Must be able to start the study drug 3 to 8 weeks after finishing chemotherapy.
- Must sign an informed consent form agreeing to participate in the study.
Exclusion Criteria
- Have certain types of uterine cancer, like clear cell or small cell carcinoma with neuroendocrine differentiation.
- Have received a blood or platelet transfusion within 2 weeks before starting the study.
- Are on high-dose steroid therapy.
- Have not recovered from major surgery within 28 days before starting the study.
- Have significant side effects from previous cancer treatments that have not improved.
- Have had recent palliative radiotherapy for pain control.
- Have gastrointestinal issues that could affect the absorption of the study drug.
- Cannot tolerate anti-nausea medications.
- Have an active infection requiring treatment within 1 week of screening.
- Have a serious psychiatric or medical condition that could interfere with the study.
- Have previously been treated with an XPO1 inhibitor.
- Have stable disease or progression on the post-chemotherapy scan.
- Have received any other cancer treatment within 3 weeks before starting the study.
- Have had major injuries or surgery within 14 days before starting the study.
- Have another cancer that has not been disease-free for at least 3 years, except for certain non-threatening cancers.
- Have a history of allergic reactions to similar drugs.
- Have active brain metastases that are not adequately treated.
- Are pregnant or breastfeeding.
- Have any other serious illness or condition that could affect participation in the study.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| The University of Alabama at Birmingham | 35205 | Birmingham | Alabama |
| Honor Health | 85016 | Phoenix | Arizona |
| University of Arkansas for Medical Sciences | 72205 | Little Rock | Arkansas |
| City of Hope National Medical Center | 91010 | Duarte | California |
| Chao Family Comprehensive Cancer Center and Ambulatory Care | 92612 | Irvine | California |
| City of Hope at Irvine Lennar | 92618 | Irvine | California |
| Cancer and Blood Specialty Clinic | 90720 | Los Alamitos | California |
| UCLA - Women's Health Clinical Research Unit | 90095 | Los Angeles | California |
| Long Beach Memorial Medical Center | 90806 | Los Angeles | California |
| UC Irvine | 92868 | Orange | California |
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