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A study of ACR-368 and gemcitabine for patients with endometrial cancer

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on individuals with Endometrial Cancer, which is a type of cancer that develops in the lining of the uterus. The purpose of the study is to evaluate the effectiveness of a combination therapy in treating this condition. The treatment involves the use of gemcitabine, a medication given through an intravenous infusion, which means it is delivered directly into a vein, along with an experimental drug known as ACR-368.

During the study, participants receive these medications to see how well they work against the tumor. The progress of the disease is monitored using imaging tools such as a computed tomography scan or an MRI, which are special types of pictures taken of the inside of the body. These tools help to determine if the cancer is shrinking or staying the same.

The research process

The trial runs in 2 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Administration of medication
The treatment involves receiving two medications through an intravenous infusion, which means the medicine is delivered directly into a vein.
The first medication is gemzar (gemcitabine) at a dose of 10 mg/m2 (milligrams per square meter of body surface area).
The second medication is acr-368 (prexasertib lactate monohydrate) at a dose of 105 mg/m2 (milligrams per square meter of body surface area).
Step 2
Monitoring and evaluation
The effectiveness of the treatment is monitored using ct scans or mri (imaging tests that create detailed pictures of the inside of the body) to check for changes in the endometrial cancer.
Regular checks are performed to monitor adverse events, which are side effects or unintended medical occurrences.
Clinical assessments are conducted, including laboratory tests, vital signs (such as blood pressure and heart rate), ecg (a test that records the electrical activity of the heart), and physical examinations.
Quality of life is tracked through the use of questionnaires to measure changes in physical and emotional well-being.

Who can join the trial?

14 criteria

You must be at least 18 years old.
You must have high-grade endometrial cancer, which means the cancer cells look very abnormal under a microscope and tend to grow quickly.
You must have metastatic cancer, meaning the cancer has spread to other parts of the body.
The cancer must have shown progression, which means the disease has gotten worse or spread further after your last treatment, as seen on medical images like scans.
You must have at least one measurable lesion, which is a tumor or area of cancer that is large enough to be clearly seen and measured on a scan.
You must have previously received platinum-based chemotherapy and anti-PD-(L)1 therapy (a type of immunotherapy used to help the immune system fight cancer).
You must not have received more than two previous types of systemic therapy (medicines that travel through the whole body to treat cancer).
You must have stabilized or recovered from side effects caused by previous treatments, except for hair loss, certain hormone changes, or neuropathy (nerve damage that causes tingling or numbness).
Your ECOG Performance Status must be 0 or 1, which is a scale used to measure how well you can perform daily activities; a score of 0 or 1 means you are still quite active.
You must have an estimated life expectancy of more than 3 months.
You must have adequate organ function and a healthy coagulation profile, which refers to your blood's ability to clot properly.
You must be willing to provide archival tumor samples, such as tissue blocks or slides, for study.
You must have taken moderate or strong inhibitors of CYP1A2 (a specific type of enzyme in the liver) within 14 days before the first dose of the study drug.
You must be willing and able to follow all study instructions and provide written informed consent, which is your signed agreement to participate after being fully informed.

Who cannot join the trial?

10 criteria

You cannot participate if you have brain metastases, which are areas of cancer that have spread to the brain, that cause symptoms and require a high daily dose of prednisolone (a type of steroid medicine used to reduce swelling). People with previous brain cancer may join if they have finished treatment, recovered from radiation or surgery, and have stable brain scans.
You are excluded if you have previously taken a cell cycle CHK1 inhibitor, which is a specific type of medicine designed to stop cancer cells from dividing.
You cannot join if you have mesenchymal tumors of the uterus, which are a specific type of tumor that grows in the connective tissues of the womb.
You are excluded if you have a history of ascites, which is a buildup of fluid in the abdomen, that required paracentesis or thoracentesis (medical procedures where a needle is used to drain fluid from the belly or chest) for treatment within the last 4 weeks.
You cannot participate if you have received systemic therapy (treatment that travels through the whole body, like chemotherapy) or radiation therapy within 3 weeks before the first dose of the study drug.
You are excluded if you have an uncontrolled infection of HIV, hepatitis B, or hepatitis C.
You cannot join if you have a history of coagulopathy or bleeding diathesis, which are medical conditions that prevent your blood from clotting normally and increase your risk of bleeding.
You are excluded if you have cardiovascular disease, which refers to conditions affecting the heart or blood vessels.
You cannot participate if you have had major surgery within the 4 weeks before the screening process.
You are excluded if you have had a bowel obstruction (a blockage in the intestines) caused by your cancer in the last 6 months, or if you have shown signs of an intestinal blockage, such as nausea or vomiting, in the 4 weeks before starting treatment.

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Verified sites

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Responsive
Azienda Ospedaliera Ordine Mauriziano Di Torino
Turin, Italy
Responsive
Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz
Madrid, Spain
Responsive
Istituto Europeo Di Oncologia S.r.l.
Milan, Italy

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Investigated drugs

Gemcitabine
is a type of chemotherapy medication that is given through a vein to help stop the growth of cancer cells.
ACR-368
is an experimental therapy being tested to see how well it can fight cancer cells in people with endometrial cancer.

Gemcitabine

What is already known about the treatment

Gemcitabine
This medication is administered as a liquid through an intravenous infusion directly into a vein. It is a well-established chemotherapy drug used to treat various types of cancer by interfering with the way cancer cells copy their DNA, which prevents them from growing and multiplying. Belonging to a class called antimetabolites, it works by mimicking the natural building blocks of DNA to trick and destroy rapidly dividing cells.
Prexasertib lactate monohydrate
This substance is provided in a vial and is given to patients through an intravenous infusion. It is an experimental drug currently being studied in clinical trials and is not yet widely available for general medical use. As a highly targeted therapy, it works at a molecular level by blocking specific proteins that help cancer cells survive and divide, effectively shutting down the cell's internal growth signals.

Investigated diseases

Endometrial cancer - This is a type of cancer that starts in the lining of the uterus, known as the endometrium. It typically begins when cells in this lining grow and multiply uncontrollably. As the disease develops, these abnormal cells can form a mass or tumor. The cancer may stay localized within the uterine lining or spread to nearby tissues and organs. Over time, the growth can continue to expand through the uterine wall.