Active not recruitingPHASE3INTERVENTIONAL

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

This research study is investigating a new medicine, selinexor, to see if it can help people with advanced or recurring womb cancer (endometrial carcinoma). The study is specifically for those whose cancer has a certain genetic characteristic (p53 wild-type) and has improved after their regular chemotherapy treatment. Participants will be split into two groups: one will receive selinexor, and the other will receive a dummy pill (placebo). The main aim is to find out if selinexor helps keep the cancer from returning for longer and if it's safe to use. This is a maintenance treatment, meaning it's given after the main treatment to try and prevent cancer relapse.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Karyopharm Therapeutics Inc

Enrolment target

257

Start

18 Apr 2023

Estimated completion

01 Jan 2028

Endometrial Cancer

What is this study about?

This study is looking at a new way to treat advanced or recurring womb cancer, also known as endometrial carcinoma. After someone has had their initial chemotherapy – usually a platinum-based treatment – and their cancer has improved significantly, doctors want to see if there's a treatment that can help keep the cancer from coming back. This type of treatment is called 'maintenance therapy'.

The medicine being tested is called selinexor. Researchers want to compare selinexor with a dummy pill, known as a placebo. This helps them understand if any changes seen in patients are truly due to the selinexor or if they might happen anyway. The study focuses on a specific type of womb cancer where a gene called p53 is 'wild-type', which means it's working normally. This is important because medicines can work differently depending on a person's specific cancer characteristics.

The main goal is to find out if selinexor is effective at preventing the cancer from returning for longer, and to understand any side effects it might have. Ultimately, this research aims to find better ways to help people with womb cancer stay healthier for longer after their initial treatment.

Key takeaways

This study is for people with advanced or recurring womb cancer.
It tests a new drug called selinexor as a 'maintenance' treatment after chemotherapy.
Participants will either receive selinexor or a dummy pill (placebo).
The goal is to see if selinexor helps keep the cancer from returning and if it's safe.
Specific genetic features of your cancer (p53 wild-type) are needed to join.
Participation involves regular checks and might last an extended period.

Who may be eligible?

To join this study, you need to be an adult of 18 years or older with womb cancer (endometrial carcinoma). Your cancer specifically needs to be identified as having a 'p53 wild-type' characteristic, which the study will check for using a special test.

You must have already completed at least 12 weeks of standard chemotherapy, which included a platinum-based drug, and your cancer must have shown a good response (either partially or completely improved). You should also be generally well, meaning you're able to carry out most of your daily activities without too much difficulty, and your body's main organs should be working properly. You must be able to start the study treatment within 3 to 8 weeks after your last chemotherapy dose.

There are also some reasons you wouldn't be able to join. For example, if you have certain other types of womb cancer (like uterine sarcomas), if your cancer got worse after your last chemotherapy, or if you've already had a specific type of drug called an XPO1 inhibitor. Other reasons include being pregnant or breastfeeding, or having other serious health problems that might make taking part unsafe or difficult.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have a specific type of womb cancer (endometrial carcinoma) that is 'p53 wild-type'?
Have you finished at least 12 weeks of platinum-based chemotherapy and your cancer has responded well?
Are you generally well and able to manage most daily activities?
Are you able to start a new treatment within 3-8 weeks of your last chemotherapy?
Are you currently not pregnant or breastfeeding?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you’ll be randomly assigned to one of two groups: one receiving selinexor and the other receiving a placebo (a dummy pill that looks like selinexor but has no active medicine). This is like flipping a coin, so neither you nor your doctor can choose which group you’re in. You'll take the assigned medication regularly.

You will have regular visits to the hospital for checks. These visits will involve physical examinations, blood tests, and scans to monitor your health and how your cancer is responding. The doctors will also ask you questions about how you’re feeling and any side effects you might be experiencing. The total length of your participation will depend on how your cancer responds to the treatment.

Potential risks and benefits

Taking part in a study like this might have potential benefits. You could receive a new treatment that isn't widely available yet, which might help keep your cancer from coming back for longer. However, there's no guarantee that selinexor will work for you, and it might not be better than the placebo. Like all medicines, selinexor can have side effects, which could be mild or more serious. The study team will monitor you closely for any unwanted effects. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (204)

The University of Alabama at Birmingham
Verified postcode
Birmingham, United States
Honor Health
Verified postcode
Phoenix, United States
University of Arkansas for Medical Sciences
Verified postcode
Little Rock, United States
UC DAVIS
Verified postcode
Davis, United States
City of Hope National Medical Center
Verified postcode
Duarte, United States
City of Hope at Irvine Lennar
Verified postcode
Irvine, United States
Cancer and Blood Specialty Clinic
Verified postcode
Los Alamitos, United States
UCLA - Women's Health Clinical Research Unit
Verified postcode
Los Angeles, United States
Long Beach Memorial Medical Center
Verified postcode
Los Angeles, United States
Stanford University
Verified postcode
Palo Alto, United States
California Pacific Medical Center
Verified postcode
San Francisco, United States
Broward Health Medical Center
Verified postcode
Fort Lauderdale, United States

Common questions

What is endometrial carcinoma?

Endometrial carcinoma is a type of cancer that starts in the lining of the womb (uterus).

What does 'maintenance therapy' mean?

Maintenance therapy is treatment given after initial cancer treatment has worked well, to try and prevent the cancer from returning.

What is a 'placebo'?

A placebo is a dummy pill or treatment that looks exactly like the real medicine but contains no active drug. It helps researchers compare the new medicine's effects.

What is 'p53 wild-type'?

'p53 wild-type' refers to a normal version of a specific gene called p53, which plays a role in controlling cell growth. It helps doctors decide if certain treatments might be more effective.

Can I choose to get selinexor?

No, participants are randomly assigned to either receive selinexor or the placebo, like drawing names from a hat. This ensures the study results are fair and unbiased.