RecruitingPHASE1INTERVENTIONAL

Investigating Idetrexed and Olaparib in Patients With Ovarian Cancer

This study is investigating a new way to treat a specific type of ovarian cancer called high-grade serous ovarian cancer, especially when standard treatments haven't worked or aren't an option. Researchers are combining two drugs: Idetrexed and olaparib. Idetrexed is designed to find and attack cancer cells that have a certain protein (folate receptor) on their surface, stopping them from growing. Olaparib works by preventing cancer cells from repairing their DNA, which leads to their death. The idea is that using these two drugs together will be more effective at killing cancer cells, particularly those with the folate receptor, while being kinder to healthy cells. This is an early-stage study (Phase 1) to understand how safe the drugs are and what doses work best.

At a glance

Status

Recruiting

Phase

PHASE1

Sponsor

Institute of Cancer Research, United Kingdom

Enrolment target

Start

01 Aug 2025

Estimated completion

01 Dec 2029

High Grade Serous Ovarian Cancer

What is this study about?

This study is a Phase 1 clinical trial, which means it's one of the first times these specific drugs are being tested together in people. The main purpose is to find out if combining two anti-cancer drugs, called Idetrexed and olaparib, is safe and what the best dose is. They are focusing on a particular type of ovarian cancer known as high-grade serous ovarian cancer, especially in situations where other treatments haven't been successful or aren't suitable for the patient.

Let's break down how these drugs are thought to work. Idetrexed is designed to be a clever drug that specifically targets cancer cells. Many cancer cells have a particular protein, called a folate receptor, on their surface. Idetrexed is like a guided missile that seeks out these receptors. Once it finds them, it stops cancer cells from making new DNA, which is essential for them to grow and multiply. Without new DNA, the cancer cells can't keep reproducing.

Olaparib is the second drug in this combination. It also works by damaging cancer cells. Our bodies, including cancer cells, have ways to repair damaged DNA. Olaparib interferes with this repair process in cancer cells. So, if cancer cells can't fix their DNA, they can't survive and eventually die. The hope is that by combining Idetrexed, which damages DNA, with olaparib, which stops repair, the treatment will be much more powerful against cancer cells, especially those with the folate receptors. The aim is to kill more cancer cells while being gentler on healthy cells.

Key takeaways

This study is for high-grade serous ovarian cancer that hasn't responded to other treatments.
It combines two drugs, Idetrexed and olaparib, to attack cancer cells in new ways.
This is an early-stage study (Phase 1) focused on finding a safe and effective dose.
You'll be closely monitored with regular visits and tests.
You can leave the study at any time without affecting your future care.

Who may be eligible?

To join this study, you would need to meet certain conditions. It's for women aged 18 or older who have been diagnosed with high-grade serous ovarian cancer that has already been proven by tests. This is for patients whose cancer has not responded to usual treatments, or for whom standard treatments are not an option or have been declined.

Researchers will also check your general health. This includes having good overall physical health, as measured by a particular scale (a WHO performance status of 0-1, which means you can mostly carry out your usual activities with little to no difficulty). Your body's organs, such as your heart and lungs, need to be working well, and your blood test results must fall within certain healthy ranges. Your medical team will perform these checks. You would also need to have areas of cancer that can be measured or monitored by doctors.

There are also some reasons why you might not be able to join. For example, if you've recently had other cancer treatments like radiotherapy or chemotherapy within the last four weeks (or six weeks for some specific drugs), you wouldn't be eligible. Also, patients with new brain or lung cancer spots are not included. If you’ve been treated for brain cancer spread in the past and it’s now stable, you might be able to join. Your doctor will discuss all these details with you.

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 high-grade serous ovarian cancer?
Has your cancer not responded to usual treatments, or are those treatments not suitable for you?
Is your general health good enough to participate in a study?
Have you not had other cancer treatments like chemotherapy or radiotherapy in the last 4 (or 6) weeks?
Do your doctors think your heart and lungs are in good working order?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will first have a check-up to make sure you meet all the requirements. This will include blood tests, heart checks (ECG), lung function tests, and scans to assess your cancer. Once you're enrolled, you'll receive the two study drugs, Idetrexed and olaparib, likely as tablets or capsules, depending on the dosage form. The study has different treatment levels to find the safest and most effective dose.

You will have regular visits to the hospital for assessments, which will involve more blood tests, physical examinations, and scans to see how your body is reacting to the treatment and how the cancer is responding. These visits are important for monitoring your health and the effects of the treatment. The total duration of your participation will depend on how you respond to the treatment and the study's design, but treatments typically continue as long as they are helping and you are tolerating them well. You will also have follow-up appointments after you stop receiving the study drugs.

Potential risks and benefits

Taking part in a clinical trial like this can have potential benefits. While there's no guarantee the treatment will work for you, you'll receive a new combination of drugs that might be more effective than existing treatments for your specific type of ovarian cancer. You'll also be closely monitored by a dedicated medical team. However, there are also potential risks, as all medications can have side effects. These drugs may cause side effects that are currently unknown or more severe than expected. Your doctors will explain all known side effects and monitor you very carefully for any new ones. It’s important to remember that you can decide to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (3)

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

Addenbrooke's Hospital
Verified postcode
Cambridge, United Kingdom· Not yet recruiting
Royal Marsden Hospital - Drug Development Unit
Verified postcode
Sutton, United Kingdom· Recruiting
Velindre Cancer Centre
Verified postcode
Cardiff, United Kingdom· Not yet recruiting

Common questions

What type of cancer is this study for?

This study is for high-grade serous ovarian cancer, especially when previous treatments haven't worked or aren't an option.

What are Idetrexed and olaparib?

They are cancer drugs. Idetrexed targets specific cancer cells to stop their growth, and olaparib prevents cancer cells from repairing themselves, leading to their death.

Why combine these two drugs?

The idea is that together, they might be more powerful at killing cancer cells, especially those with certain markers, than either drug alone.

Is this a new treatment?

Yes, this is a Phase 1 study, meaning it's one of the first times these two drugs are being tested together in people to understand safety and dosing.

Will I have side effects?

All medicines can have side effects. The study team will monitor you closely and explain any known possible side effects of these drugs.

How to find out more

Alexander Cowley, Ph.D.

idol@icr.ac.uk +44 20 3437 6927 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.