NCT05611931进行中（未招募）3 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 257
- 试验地点
- 422
- 主要终点
- Investigator assessed Progression Free Survival (PFS) per RECIST v1.1
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Double blind placebo-controlled study
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 NGS
- •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
排除标准
- •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
研究组 & 干预措施
Selinexor
Experimental
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.
干预措施: Selinexor (Drug)
Placebo
Placebo Comparator
Participants will receive matching placebo for selinexor oral tablets QW on Days 1, 8, 15, and 22 of each 28-day cycle.
干预措施: Matching Placebo for selinexor (Drug)
结局指标
主要结局
Investigator assessed Progression Free Survival (PFS) per RECIST v1.1
时间窗: From randomization until disease progression (PD) or death, whichever occurs first (up to 34 months)
次要结局
- Time to Second Subsequent Therapy (TSST)(From randomization until date of initiation of second therapy after discontinuation of study drug or death, whichever occurs first (up to 34 months))
- Progression-free survival after initiating a next-line treatment (PFS2)(From randomization until the next-line progression event or death due to any cause, up to 34 months)
- Progression-free Survival (PFS) as assessed by a Blinded Independent Central Review (BICR), per RECIST v1.1(From randomization until disease progression (PD) or death, whichever occurs first (up to 34 months))
- Safety and tolerability of study drug (selinexor and placebo)(From start of study drug administration up to 34 months)
- Time to First Subsequent Therapy (TFST)(From randomization until date of initiation of first therapy after discontinuation of study drug or death, whichever occurs first (up to 34 months))
- Overall Survival (OS)(Up to 34 months)
- Overall Survival (OS)(Up to 34 months)
- Safety and tolerability of study drug (selinexor and placebo)(From start of study drug administration up to 34 months)
- Time to First Subsequent Therapy (TFST)(From randomization until date of initiation of first therapy after discontinuation of study drug or death, whichever occurs first (up to 34 months))
- Time to Second Subsequent Therapy (TSST)(From randomization until date of initiation of second therapy after discontinuation of study drug or death, whichever occurs first (up to 34 months))
- Progression-free survival after initiating a next-line treatment (PFS2)(From randomization until the next-line progression event or death due to any cause, up to 34 months)
- Progression-free Survival (PFS) as assessed by a Blinded Independent Central Review (BICR), per RECIST v1.1(From randomization until disease progression (PD) or death, whichever occurs first (up to 34 months))
- EuroQol-5 Dimensions-5 Levels Quality of Life Questionnaire (EQ-5D-5L)(From baseline and at specified timepoints up to 34 months)
研究者
研究点 (422)
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相关资讯
Selinexor Maintenance Therapy Shows Sustained Benefit in TP53 Wild-Type Advanced Endometrial Cancer- Long-term follow-up from the phase 3 SIENDO trial demonstrates that selinexor maintenance therapy provides durable clinical benefit in patients with TP53 wild-type advanced or recurrent endometrial cancer.
- In the TP53 wild-type/mismatch repair-proficient subgroup, selinexor achieved a median progression-free survival of 39.5 months compared to 4.9 months with placebo.
- The treatment showed consistent improvements across multiple efficacy endpoints including time to first subsequent therapy and second progression-free survival, regardless of mismatch repair status.
- Safety profile remained manageable with nausea being the most common adverse event, occurring in 90% of selinexor-treated patients.last yearKaryopharm's Selinexor Shows Promise in Myelofibrosis, Phase 3 Data Expected in 2H 2025- Karyopharm Therapeutics anticipates top-line results from its Phase 3 SENTRY trial of selinexor plus ruxolitinib for JAKi-naïve myelofibrosis in the second half of 2025.
- The SENTRY trial updated its co-primary endpoint to absolute mean change in total symptom score (Abs-TSS) and increased the sample size to 350 patients.
- Preliminary 2024 results show total revenue of approximately $145 million, with XPOVIO net product revenue reaching $113 million for Karyopharm.last yearKaryopharm Announces FDA Discussions Regarding Selinexor's Endometrial Cancer Program- Karyopharm Therapeutics is engaging with the FDA to discuss the evolving treatment landscape in endometrial cancer and its impact on the Phase 3 XPORT-EC-042 trial.
- The XPORT-EC-042 trial is evaluating selinexor as maintenance therapy for TP53 wild-type advanced or recurrent endometrial cancer following systemic treatment.
- Karyopharm has paused discussions on its endometrial cancer program at the Piper Sandler conference, awaiting further clarity from the FDA interaction.
- An update on the endometrial cancer program will be provided by Karyopharm following the discussions with the FDA.last year