Ongoing, recruitingPhase II and Phase III (Integrated)Interventional

A Phase 2/3 Study of Navtemadlin as Maintenance Therapy in Subjects with TP53WT Advanced or Recurrent Endometrial Cancer Who Responded to Chemotherapy

This research trial is for women with advanced or recurrent endometrial cancer who have responded well to initial chemotherapy. The study is testing a new drug called Navtemadlin as a 'maintenance therapy'. This means it's given after the main treatment to try and keep the cancer from growing or coming back. The trial is in two main parts (Phase 2 and Phase 3). The first part helps decide the best dose of Navtemadlin. The second part compares Navtemadlin to a dummy treatment (placebo) to see if it helps women live longer without their cancer getting worse, and whether it's safe to use.

At a glance

Status

Ongoing, recruiting

Phase

Phase II and Phase III (Integrated)

Sponsor

Kartos Therapeutics Inc.

Enrolment target

140

Start

21 Jul 2023

Advanced or Recurrent Endometrial Cancer

What is this study about?

This study is about a type of cancer that starts in the lining of the womb, called endometrial cancer. It focuses on women whose cancer is advanced (meaning it has spread) or has come back after treatment. Crucially, it's for those who have already had chemotherapy and their cancer responded positively to it.

After chemotherapy, sometimes a 'maintenance therapy' is given. This isn't meant to cure the cancer, but to keep it under control for as long as possible. This study is testing a new drug, Navtemadlin, to see if it can do just that – help prevent the cancer from growing or returning after a good response to chemotherapy. The trial is run in two stages: an early stage (Phase 2) to find the safest and most effective dose, and a larger stage (Phase 3) to confirm its benefits and side effects compared to a dummy treatment (placebo).

The main things the researchers want to find out are how safe Navtemadlin is (its side effects) and if it helps women live longer without their cancer progressing. They will also look at how long people live overall, and how well their cancer responds to the treatment. Additionally, they'll check how the drug moves through the body. This information will help doctors understand if Navtemadlin could be a useful new treatment option for women with this type of endometrial cancer.

Key takeaways

Targets advanced/recurrent womb cancer.
For women who responded well to chemotherapy.
Tests Navtemadlin as a 'maintenance' drug.
Aims to see if cancer can be kept at bay longer.
Compares Navtemadlin to a dummy (placebo) treatment.
Involves regular hospital visits and monitoring.

Who may be eligible?

This study is specifically for women who are 18 years old or older. You must have advanced or recurrent endometrial cancer, meaning the cancer has spread beyond its original site or has come back after previous treatment.

Importantly, your cancer must have a specific characteristic: it should be 'TP53 wild-type'. Your doctor will be able to tell you if your cancer has this specific feature. You also need to have responded positively to previous chemotherapy treatment for your cancer, showing that the chemotherapy helped to shrink or control it.

There will be other detailed medical checks to make sure the study is a good fit for you and that it's safe for you to take part. These checks will be done by the study doctors and nurses.

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.

Am I 18 years old or older?
Do I have advanced or recurrent endometrial (womb) cancer?
Did my cancer respond positively to previous chemotherapy?
Has my doctor confirmed my cancer is 'TP53 wild-type'?
Am I able to attend regular hospital visits and tests?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll be given either the new drug, Navtemadlin, or a dummy pill (placebo). You'll also receive standard medications like Loperamide (for diarrhoea) and Ondansetron (for sickness) or their matched placebo, depending on what the study doctors decide is best for you. The study involves regular visits to the hospital or clinic where you will undergo various tests. These include blood tests, physical examinations, and scans to monitor your cancer and your general health. You will also need to report any side effects you experience.

The study is split into two phases. The first phase helps determine the best dose of Navtemadlin. The second, larger phase then compares this dose to a placebo to fully understand its effects. The total length of your participation will depend on how you respond to the treatment and the study's design, but it will involve ongoing assessments as long as you are receiving the study medication and potentially for a follow-up period afterwards.

Potential risks and benefits

Like all medical studies, there are potential benefits and risks. You might benefit if Navtemadlin helps to keep your cancer from returning or progressing for longer than standard treatment, though this is not guaranteed. However, the drug may also cause side effects, which the study team will monitor closely. You can withdraw from the study at any time, for any reason, without it affecting your usual medical care. The doctor will discuss all known risks and potential benefits with you in detail before you decide whether to participate.

Locations (15)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Lithuania
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Unverified
Estonia
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Unverified
Denmark
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Unverified
Norway
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Unverified
Hungary
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Unverified
Spain
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Unverified
Poland
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Unverified
Slovenia
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Unverified
Romania
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Unverified
Italy
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Unverified
Sweden
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Unverified
Austria

Common questions

What is endometrial cancer?

Endometrial cancer is a type of cancer that starts in the lining of the womb (uterus). This study is for women whose cancer has spread or has come back after treatment.

What does 'maintenance therapy' mean?

Maintenance therapy is a treatment given after the main cancer treatment (like chemotherapy) has finished. It's meant to help keep the cancer under control and prevent it from growing or coming back for as long as possible.

What is a 'placebo'?

A placebo is adummy pill that looks exactly like the study drug but contains no active medicine. It helps researchers compare the real drug's effects against having no active treatment.

What is the difference between Phase 2 and Phase 3?

Phase 2 studies help find the best dose and check for common side effects. Phase 3 studies are larger and compare the new drug to existing treatments or a placebo to confirm its effectiveness and safety before it can be widely used.

Will I know if I'm getting the active drug or the placebo?

No, during the study, neither you nor your study doctor will usually know if you're receiving the active drug or a placebo. This is to ensure the study results are fair and unbiased.