Study on Selinexor as Maintenance Therapy for Patients with Advanced or Recurrent Endometrial Cancer After Chemotherapy

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What is this study about?

This clinical trial is focused on studying endometrial cancer, which is a type of cancer that begins in the lining of the uterus. The study is investigating the effects of a medication called Selinexor, which is taken as a film-coated tablet. The purpose of the study is to evaluate how effective Selinexor is compared to a placebo when used as a maintenance therapy after patients have received combination chemotherapy for advanced or recurrent endometrial cancer.

Participants in the study will be randomly assigned to receive either Selinexor or a placebo. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual medication and who is receiving the placebo. This helps ensure that the results are unbiased. The treatment will be administered orally, and the maximum treatment period is four months. The study will monitor the participants’ health and any changes in their condition over time.

The main goal of the study is to assess the progression-free survival, which refers to the length of time during and after treatment that a patient lives with the disease without it getting worse. Other aspects being evaluated include the time to first and second subsequent therapies, overall survival, and the safety and tolerability of the treatment. Participants’ quality of life will also be assessed using specific questionnaires. The study aims to provide valuable information on the potential benefits of Selinexor for patients with advanced or recurrent endometrial cancer.

1 joining the trial

Upon joining the trial, you will be randomly assigned to receive either the study medication, selinexor, or a placebo. A placebo is a substance with no active medication, used to compare the effects of the actual drug.

The trial is double-blind, meaning neither you nor the researchers will know which treatment you are receiving to ensure unbiased results.

2 medication administration

You will take the assigned medication orally. The dosage and frequency will be determined by the study protocol, which will be explained to you by the study team.

The duration of the medication administration will be specified by the study team, and you will be required to follow the instructions carefully.

3 regular check-ups

Throughout the trial, you will have regular check-ups to monitor your health and the effects of the medication. These check-ups will include physical examinations and laboratory tests.

The study team will assess your progress and any side effects you may experience. It is important to report any new symptoms or concerns during these visits.

4 progress evaluation

Your progress will be evaluated using specific criteria to determine how the treatment is affecting your condition. This includes measuring progression-free survival, which is the time during and after the treatment that you live with the disease without it getting worse.

The evaluation will also consider your overall survival and quality of life, using standardized questionnaires.

5 end of trial

At the end of the trial, you will have a final assessment to evaluate the overall impact of the treatment.

The study team will discuss the results with you and provide guidance on the next steps for your care.

Who Can Join the Study?

Must be female and at least 18 years old.
Must have a confirmed diagnosis of endometrial cancer of specific types: endometrioid, serous, or undifferentiated. A type called carcinosarcoma of the uterus is also allowed.
Must have completed at least 12 weeks of a specific chemotherapy treatment (taxane-platinum combination) for advanced cancer or after the first relapse, and be in partial or complete remission. This means the cancer has either shrunk or disappeared.
Must be able to start the study drug 5 to 8 weeks after finishing the last dose of chemotherapy.
Must have an ECOG performance status of 0-1, which means being fully active or having some symptoms but still able to carry out light work.
Must have certain levels of liver, blood, and kidney function:
- Liver function: Total bilirubin up to 1.5 times the normal limit; ALT and AST up to 2.5 times the normal limit if there is no liver tumor. If there is a liver tumor, AST and ALT up to 5 times the normal limit.
- Blood function: Absolute neutrophil count (ANC) of at least 1.5 x 10⁹/L; platelet count of at least 100 x 10⁹/L; hemoglobin of at least 9.0 g/dL.
- Kidney function: Estimated creatinine clearance (CrCl) of at least 30 mL/min, which measures how well the kidneys are working.
In the opinion of the study doctor, must have a life expectancy of at least 12 weeks and be fit to receive the study treatment.
If premenopausal and able to have children, must have a negative pregnancy test before starting the study drug and agree to use effective birth control during the study and for 3 months after the last dose.
Must provide written informed consent before any study procedures, meaning you agree to participate after understanding the study details.

Who Cannot Join the Study?

Patients who do not have endometrial cancer cannot participate.
Only female patients are eligible for this study.
Patients who are younger than 18 years old or older than 65 years old cannot participate.
Patients who are part of a vulnerable population (such as those unable to give consent) are not eligible.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
Hospital Universitario Y Politecnico La Fe	Valencia	Spain
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz	Mainz	Germany
Technische Universitaet Dresden	Dresden	Germany
Katholieke Universiteit te Leuven	Leuven	Belgium

Other Sites

Site Name	City	Country
IRCCS Istituto Nazionale Tumori Fondazione Pascale	Naples	Italy
Universitaetsklinikum Schleswig-Holstein AöR	Kiel	Germany
Hospital Universitario Puerta De Hierro De Majadahonda	Majadahonda	Spain
Fundacion Instituto Valenciano De Oncologia	Valencia	Spain
AZ Turnhout	Turnhout	Belgium
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur	Namur	Belgium
Fakultni Nemocnice Bulovka	Prague	Czechia
Hospital Clinico Universitario Lozano Blesa	Zaragoza	Spain
CHR Verviers	Verviers	Belgium
Azienda Ulss 3 Serenissima	Venice	Italy
Caritas Traegergesellschaft Saarbruecken mbH (CTS)	Saarbrücken	Germany
Consorci Sanitari De Terrassa	Terrassa	Spain
Hospital Universitario Infanta Sofía	San Sebastian De Los Reyes	Spain
Hospital Universitario Ramon Y Cajal	Madrid	Spain
Hospital Clinico Universitario De Valencia	Valencia	Spain
Virgen del Rocío University Hospital	Sevilla	Spain
Ospedale San Raffaele S.r.l.	Milan	Italy
Alexandra Hospital	Athens	Greece
Istituto Di Candiolo Fondazione Del Piemonte Per Loncologia IRCCS	Candiolo	Italy
Hospital Clinic De Barcelona	Barcelona	Spain
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Fakultni Nemocnice Brno	Brno	Czechia
University Clinical Hospital Virgen De La Arrixaca	Murcia	Spain
Hospital Son Llatzer	Palma	Spain
Jan Yperman Ziekenhuis	Ieper	Belgium
Vseobecna Fakultni Nemocnice V Praze	Prague	Czechia
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH	Ulm	Germany
Universitair Ziekenhuis Gent	Gent	Belgium
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
University Hospital Ostrava	Ostrava	Czechia
Djsznzlxz Kpsrdiqowmt gnzqt	Hanover	Germany
Ijcfaosm Rabdgeksg Pnk Ln Sxtugm Djm Txipuq Dqef Aitypnv Iddn Sbpuvf	Meldola	Italy
Hvmjnczi Uwuntbqeorydt Drhgzseg	Donostia / San Sebastian	Spain
Knjvfyjc dpq Udciyjcccyai Mnsjlykb Ats	Munich	Germany
Hmlbuyow Vatp dgxvdvyw	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	01.01.2018
Czechia	Not recruiting	01.01.2018
Germany	Not recruiting	01.01.2018
Greece	Not recruiting	01.01.2018
Italy	Not recruiting	01.01.2018
Spain	Not recruiting	01.01.2018

Trial locations

Investigated drugs:

Selinexor

Selinexor is a medication being studied for its potential to help patients with advanced or recurrent endometrial cancer. It is used as a maintenance therapy, which means it is given to help keep the cancer from coming back after initial treatment. Selinexor works by blocking certain proteins in cancer cells, which may help to slow down or stop the growth of the cancer. This trial is testing how effective Selinexor is in comparison to a placebo, which is a substance with no active medication, to see if it can improve outcomes for patients with this type of cancer.

Investigated diseases:

Endometrial Cancer – Endometrial cancer is a type of cancer that begins in the lining of the uterus, known as the endometrium. It typically progresses slowly, starting with abnormal cell growth in the endometrial lining. As the disease advances, these cancerous cells can invade deeper layers of the uterus and may spread to nearby organs. In some cases, the cancer can metastasize to distant parts of the body through the lymphatic system or bloodstream. Symptoms often include abnormal vaginal bleeding, pelvic pain, and changes in menstrual cycles. The progression of the disease can vary, with some cases remaining localized while others become more aggressive and widespread.

Trial ID:

2024-513167-68-00

NCT ID:

NCT03555422

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Selinexor as Maintenance Therapy for Patients with Advanced or Recurrent Endometrial Cancer After Chemotherapy

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