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Selinexor in Maintenance Therapy After Systemic Therapy for Participants With p53 Wild-Type, Advanced or Recurrent Endometrial Carcinoma

Endometrial Cancer

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.

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Conditions de participation

  • Sexe:

    ALL
  • Âges admissibles:

    18 and up

Critères de participation

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

Lieu de l'étude

Cross Cancer Institute
Cross Cancer Institute
Edmonton, Alberta
Canada

Contactez l'équipe d'étude

Primary Contact

Jennifer Rauw

[email protected]
Centre Hospitalier de l'Université de Montréal
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec
Canada

Contactez l'équipe d'étude

Primary Contact

Bonny Choy

[email protected]
514-890-8000 x24672
Princess Margaret
Princess Margaret
Toronto, Ontario
Canada

Contactez l'équipe d'étude

Primary Contact

Lila Shapiro

[email protected]
416-946-4501
Hospital Maisonneuve-Rosemont
Hospital Maisonneuve-Rosemont
Montreal, Quebec
Canada

Contactez l'équipe d'étude

Primary Contact

Suzanne Fortin

[email protected]
Nova Scotia Health / QEII Health Sciences Centre / Atlantic Clinical Cancer Research Unit
Nova Scotia Health / QEII Health Sciences Centre / Atlantic Clinical Cancer Research Unit
Halifax, Nova Scotia
Canada

Contactez l'équipe d'étude

Primary Contact

Alison Avery

[email protected]
902-473-7351
McGill University Health Centre (MUHC)
McGill University Health Centre (MUHC)
Montreal, Quebec
Canada

Contactez l'équipe d'étude

Primary Contact

Nathalie Nguyen-Phuong-Nam

[email protected]
Tom Baker Cancer Centre
Tom Baker Cancer Centre
Calgary, Alberta
Canada

Contactez l'équipe d'étude

Primary Contact

Prafull Ghatage

[email protected]
Sunnybrook Research Institute
Sunnybrook Research Institute
Toronto, Ontario
Canada

Contactez l'équipe d'étude

Primary Contact

Nithla Mohanathas

[email protected]
416-480-5000
Étude parrainée par
Karyopharm Therapeutics Inc
Participants recherchés
Plus d'informations
ID de l'étude: NCT05611931