Not recruiting

A study to evaluate the safety and effectiveness of AZD9750 and saruparib in patients with metastatic prostate cancer

Verified siteInvestigationalNo placebo

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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 Metastatic Prostate Cancer, a type of cancer where the disease has spread from the prostate to other parts of the body. The research aims to evaluate the safety and effectiveness of the drug AZD9750, which is administered as an oral film-coated tablet. This medication may be used alone as a monotherapy or in combination with other anticancer agents, which are substances used to fight cancer cells.

The study is divided into different parts to closely monitor how the body reacts to the treatment. One part of the research looks at how the medication is processed by the body and determines the maximum tolerated dose, which is the highest amount of a drug that can be given without causing unacceptable side effects. Another part of the study examines the preliminary ability of AZD9750 to shrink tumors or reduce the levels of PSA, a protein used to track prostate cancer activity.

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
Participation in the study
The study begins with the administration of azd9750, which is provided as a film-coated tablet to be taken by mouth.
The study also involves the use of saruparib, which is provided as a tablet to be taken by mouth.
These medications may be given as a monotherapy, which means using only one drug, or in combination with other anticancer agents.
Step 2
Safety and efficacy monitoring
During the study, safety is monitored by checking for adverse events, which are any unwanted or harmful medical occurrences.
Physical assessments are performed, including monitoring of vital signs, physical examinations, and electrocardiograms (tests that record the electrical activity of the heart).
laboratory parameters, such as blood tests, are monitored to check for changes from the start of the study.
The effectiveness of the treatment is evaluated by measuring psa levels (a protein found in the blood that can indicate prostate cancer activity) to see if there is a decrease in the amount present.
The size of tumors (abnormal growths of tissue) is assessed using specific medical criteria to determine how the cancer responds to the treatment.

Who can join the trial?

10 criteria

You must be 18 years of age or older at the time you sign the form to join the study.
You must be expected to live for at least 12 weeks.
You must have a confirmed diagnosis of adenocarcinoma of the prostate, which is a type of cancer that starts in the cells of the prostate gland.
Your cancer must be metastatic, meaning it has spread from the prostate to other parts of the body, such as the bones or soft tissue (the tissues surrounding your organs and bones). This must be visible on standard medical scans.
You must have undergone castration, either through surgery or medication, to lower your hormone levels. This means your testosterone (a male sex hormone) levels must be 50 ng/dL or less.
Your cancer must have shown signs of progression, which means the disease is growing or getting worse, even while receiving androgen deprivation therapy (ADT), a common treatment that lowers hormone levels to slow cancer growth. This can be shown by rising PSA levels (a protein produced by the prostate that often increases when cancer is present) or by new cancer spots appearing on medical scans.
You must have an ECOG performance status of 0 or 1, which is a scale used by doctors to measure how well you can perform daily activities and how much the cancer affects your physical abilities.
Your bone marrow (the part inside bones that makes blood cells) and your organs (such as the liver or kidneys) must be functioning well.
You must be male as assigned at birth.
You must use contraception (methods to prevent pregnancy) in a way that follows local rules for people participating in clinical studies.

Who cannot join the trial?

18 criteria

You cannot participate if your cancer is a type of small cell carcinoma or neuroendocrine carcinoma, or if it is any type of cancer other than prostate adenocarcinoma (the most common type of prostate cancer).
You cannot participate if the cancer has spread to the brain or if there is spinal cord compression (when a tumor presses on the nerves in your spine).
You cannot participate if your heart rhythm shows a prolonged QT interval, which is a measurement of the time it takes for your heart muscle to recharge between beats.
You cannot participate if you have a family history of long QTc syndrome (a genetic heart rhythm problem) or if a close relative died suddenly and unexpectedly before age 40.
You cannot participate if you are taking any medicines that might change your heart rhythm or if you have abnormal levels of electrolytes, which are essential minerals in your blood like sodium, potassium, calcium, and magnesium.
You cannot participate if your resting heart rate is too fast (over 90 beats per minute) or too slow (under 45 beats per minute).
You cannot participate if your electrocardiogram (ECG), which is a test that records the electrical activity of your heart, shows abnormal rhythms or patterns.
You cannot participate if your left ventricular ejection fraction (LVEF) is less than 50%, which is a measurement of how much blood your heart pumps out with each beat.
You cannot participate if you have diastolic dysfunction (when the heart muscle does not relax properly between beats) or pulmonary hypertension (high blood pressure in the lungs).
You cannot participate if you have symptomatic heart failure or if you have been in the hospital for heart failure in the last 6 months.
You cannot participate if you have uncontrolled hypertension, which is high blood pressure that is consistently above 160/90 mmHg.
You cannot participate if you have had a recent heart attack, unstable chest pain, or heart surgeries like a coronary artery bypass graft in the last 6 months.
You cannot participate if you have cardiomyopathy (a disease of the heart muscle) or significant issues with your heart valves.
You cannot participate if you have a history of irregular heartbeats, known as arrhythmia, that requires treatment.
You cannot participate if you have had a stroke or a transient ischaemic attack (a temporary period of stroke-like symptoms) in the last 6 months.
You cannot participate if you have symptomatic hypotension, which means your blood pressure is too low and causing symptoms.
You cannot participate if you still have side effects from previous cancer treatments that are classified as Grade 2 or higher, which refers to moderate to severe symptoms according to a standard medical grading scale.
You cannot participate if you have previously used a type of medicine called an AR-PROTAC.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Responsive
Rotterdam, The Netherlands
Hospital Vall d’Hebron
Verified
Barcelona, Spain

Trial locations

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Investigated drugs

AZD9750
is a medication being tested to see how safe it is and how well it works to treat advanced prostate cancer, either on its own or when used together with other cancer treatments.
Saruparib
is an anticancer medication being studied in combination with other treatments to evaluate its effectiveness and safety in people with metastatic prostate cancer.

Saruparib

What is already known about the treatment

AZD9750
This medication is an experimental drug currently being studied in clinical trials and is taken as a film-coated tablet by mouth. It is classified as a PARP inhibitor, which works by blocking a specific protein that helps cancer cells repair their damaged DNA, eventually leading to the death of the cancer cells. It is being investigated primarily for its potential to treat advanced prostate cancer.
Saruparib
This is an investigational drug that is administered orally in the form of a tablet. As a PARP inhibitor, it functions by interfering with the way cancer cells fix their genetic material, making the cells more vulnerable to damage and preventing them from multiplying. While it is still under research, it is being studied for its ability to target certain types of cancer cells.

Investigated diseases

Metastatic Castration-Resistant Prostate Cancer - This condition occurs when prostate cancer cells continue to grow even when testosterone levels are very low. The cancer cells no longer respond to standard hormone therapies designed to reduce male hormones. As the disease progresses, the cancer cells may spread from the prostate to other parts of the body, such as the bones or lymph nodes. This progression is often marked by an increase in certain proteins in the blood. The cells adapt to survive in an environment with minimal hormonal stimulation.