Selinexor in Maintenance Therapy After Systemic Therapy for Participants With p53 Wild-Type, Advanced or Recurrent Endometrial Carcinoma
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
Karyopharm Therapeutics Inc
276 participants
Apr 18, 2023
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria6
- 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 Criteria8
- 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
Interventions
Dose: 60 mg (3 tablets); Dosage form: film-coated, immediate-release tablet of 20 mg each; Route of administration: oral
Dose:60 mg (3 tablets); Dosage form: film-coated, immediate-release tablet of 20 mg each; Route of administration: oral
Locations(217)
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NCT05611931