Active not recruitingPHASE1INTERVENTIONAL

Study of E7386 in Participants With Selected Advanced Neoplasms

This study is an early-stage clinical trial looking into a new medicine called E7386. It's for people who have advanced or recurring cancers for which standard treatments are no longer working. The main goals are to carefully check the safety of E7386 when taken by mouth and to understand what side effects might happen. Researchers will also be looking for the highest dose of E7386 that patients can comfortably take without too many side effects. This crucial information will help decide the best dose for larger, future studies. Taking part would mean trying a new treatment that is still in the early stages of being tested.

At a glance

Status

Active not recruiting

Phase

PHASE1

Sponsor

Eisai Inc.

Enrolment target

Start

27 Jul 2017

Estimated completion

31 Mar 2027

Advanced Neoplasms

What is this study about?

This clinical trial is about a new potential medicine called E7386. It's designed for people who have specific types of advanced cancers that have either come back after treatment or spread, and where standard treatment options are limited. Think of it as an early step in testing a new treatment – the main focus in this first stage (called Phase 1) is to understand how safe the medicine is and what the possible side effects are.

The researchers will start with a very small dose and gradually increase it in different groups of people. This careful approach helps them find the highest dose that can be given without causing too many uncomfortable or serious side effects. This dose is then usually recommended for further testing in larger studies.

Finding the right dose and understanding the safety of E7386 is really important. It helps doctors and scientists decide if this new medicine has enough promise to continue being studied and potentially help more people in the future. While this study won't confirm if E7386 can cure cancer, it is a vital step in the development of new treatments.

Key takeaways

This is an early-stage study (Phase 1) of a new medicine, E7386, for advanced cancers.
The main aims are to check safety, side effects, and find the right dose of E7386.
It's for specific types of advanced or recurring cancers with limited standard treatments.
You would take the medicine by mouth and have regular check-ups and scans.
Your participation helps future cancer research, but direct benefit for you isn't guaranteed.
You can stop participating at any time.

Who may be eligible?

To join this study, participants must be at least 18 years old. You'll need to be generally well enough to take part in a study like this, meaning you can mostly look after yourself. Doctors will also check that your body's organs, like your kidneys, are working well enough.

The study is for people with certain advanced cancers that cannot be removed by surgery, have come back since your last treatment, or need ongoing treatment. You would be considered if there are no other standard treatments available for your cancer type. Examples include specific advanced forms of desmoid tumours, thyroid cancer, endometrial cancer, melanoma, colorectal cancer, liver cancer, pancreatic cancer, prostate cancer, ovarian cancer, and head and neck cancer. In particular, some people with liver cancer who have a specific genetic change (called a CTNNB1 mutation) might be eligible. Doctors would check your exact cancer type and history to see if it fits.

To help the researchers understand how the medicine works, you would need to have a cancer area that doctors can measure clearly on scans. Sometimes, they might also need to take small samples (biopsies) from your tumour.

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 an advanced or recurring cancer for which standard treatments are not working or available?
Are you generally well enough to go about your daily activities?
Do your doctors think your kidneys and other body functions are okay for a study?
Do you have a cancer area that can be measured on a scan?
Are you willing to have regular hospital visits, blood tests, and scans?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive the study medicine, E7386, by mouth. The exact schedule for taking the medicine and the number of visits to the clinic would be explained by the study team. You would have regular check-ups, which would usually involve blood tests, physical examinations, and scans (like CT or MRI) to monitor your health and how the treatment is affecting your cancer. These scans are also used to take measurements of your cancer over time. The study team would also ask you questions about any side effects you might be experiencing.

At certain points, it might be necessary to have additional small samples (biopsies) taken from your tumour. The total length of time you would be in the study would depend on how you respond to the treatment and the study plan, but you would be regularly monitored.

Potential risks and benefits

Taking part in any clinical trial involves both potential benefits and risks. You might not directly benefit from this study, as it's primarily designed to gather information about the new medicine rather than to treat your cancer effectively. However, you would be closely monitored by a dedicated medical team, and your participation could help others in the future by contributing to the development of new cancer treatments. Possible risks include experiencing side effects from the study medicine, which could be mild, moderate, or serious. The research team will explain all known side effects and monitor you very carefully for any new ones. You are always free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (10)

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

Mayo Clinic Comprehensive Caner
Verified postcode
Phoenix, United States
USC Norris Comprehensive Cancer Center
Verified postcode
Los Angeles, United States
California Liver Research Institute
Verified postcode
Pasadena, United States
Mayo Clinic Comprehensive Cancer
Verified postcode
Jacksonville, United States
Mayo Clinic Comprehensive Caner
Verified postcode
Rochester, United States
The Beatson West of Scotland Cancer Centre
Verified postcode
Glasgow, United Kingdom
The Christie NHS Foundation Trust
Verified postcode
Manchester, United Kingdom
Royal Marsden Hospital NHS Foundation Trust
Verified postcode
Sutton, United Kingdom
Royal Free London NHS Foundation Trust, Royal Free Hospital
Verified postcode
London, United Kingdom
Imperial College Healthcare NHS Trust
Verified postcode
London, United Kingdom

Common questions

What is E7386?

E7386 is a new medicine being tested in this study. It's not yet approved and is in the early stages of research for treating certain advanced cancers.

Why is this study being done?

The main reason is to find out if E7386 is safe, what side effects it might cause, and to work out the best dose to use in future studies.

Will I definitely get better if I join this study?

Not necessarily. This is an early phase study, meaning its main goal is to understand the medicine's safety, not to cure cancer. Any benefit would be a welcome secondary outcome.

What kind of cancers are included?

It's for specific advanced or recurring cancers where standard treatments aren't available, such as certain desmoid tumours, liver cancer, and some others, as determined by the study doctors.

Can I leave the study at any time?

Yes, you are free to leave the study at any point, for any reason, and it will not affect your regular medical care.