Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

Sarcomas and DDR-Inhibition; a neoadjuvant phase I combined modality study - SADDRIN-1

This is an early-stage research study, called a Phase I trial, for adults diagnosed with soft tissue sarcoma that has not spread to other parts of the body. Soft tissue sarcoma is a rare type of cancer that can grow in soft tissues like muscle, fat, or blood vessels. The study is investigating a new way of treating this cancer by combining existing treatments with a new investigational drug. The main goal is to find out if this combination is safe and what the best dose of the new drug might be. Researchers also want to see if this new approach could help improve how well the treatments work. This is a crucial step in developing new potential therapies for soft tissue sarcoma.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting

Enrolment target

Start

24 Oct 2024

non-metastatic soft tissue sarcoma

What is this study about?

This study, called SADDRIN-1, is a very early stage (Phase I) clinical trial focusing on soft tissue sarcoma. Soft tissue sarcoma is a rare type of cancer that can develop in various soft parts of your body, such as muscles, fat, nerves, blood vessels, and other supporting tissues. In this study, they are looking at sarcomas that have not yet spread to other parts of the body, which doctors call 'non-metastatic'.

The researchers are testing a new treatment strategy. This involves giving patients standard treatments for soft tissue sarcoma, like chemotherapy or radiotherapy, along with a new investigational drug. This new drug works by targeting something called 'DDR-Inhibition'. You don't need to worry about the technical details of what DDR-Inhibition means; the important part is that it's a new way researchers hope to fight cancer cells.

The main purpose of this initial study is to check the safety of combining these treatments. They will carefully monitor participants to see if the new drug has any unexpected side effects when given with standard treatments. They also want to work out the best and safest dose of the new drug to use. By understanding the safety first, they can then move on to larger studies to see how effective this new combination might be in treating soft tissue sarcoma.

Key takeaways

This is an early-stage study for adults with soft tissue sarcoma that hasn't spread.
It's testing a new drug combined with standard treatments.
The main goals are to check for safety and find the best dose.
Participants will have regular visits and monitoring.
There are potential benefits and risks, which will be fully explained.
You can withdraw from the study at any time.

Who may be eligible?

This study is looking for adult patients who have been diagnosed with a type of cancer called 'soft tissue sarcoma'. It's important that this cancer has not spread to other parts of your body; doctors call this 'non-metastatic'.

To be considered, you must be 18 years old or older. The study is open to both men and women.

There will be other detailed criteria that your doctor will check to make sure the study treatment is safe and appropriate for you, but these are the main starting points.

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?
Have you been diagnosed with soft tissue sarcoma?
Has your doctor confirmed that your sarcoma has not spread to other parts of your body?
Are you able to attend regular hospital visits for treatments and check-ups?
Are you willing to consider receiving a new, investigational medication?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive medical examinations and assessments at regular intervals. This will include blood tests, scans (like MRI or CT scans), and other tests to see how you are responding to the treatment and to monitor for any side effects. You will receive the study medication (the new drug) in combination with other standard treatments for your sarcoma.

The study involves visits to the hospital or clinic for these treatments and check-ups. The exact number and frequency of visits will be explained to you in detail by the study team, as will the total duration of the treatment and follow-up period. You will be closely monitored throughout your involvement.

Potential risks and benefits

Taking part in a clinical trial can offer potential benefits, such as accessing new treatments not yet widely available and contributing to medical knowledge that could help future patients. However, there are also potential risks, including side effects from the investigational drug or the combination of treatments. It's important to remember that this is an early-stage study, so the long-term effects and full benefits are not yet known. You will be fully informed of all known risks before you decide to participate, and you have the right to withdraw from the study at any time, for any reason, without affecting your future medical care.

Locations (1)

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

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Unverified
Netherlands

Common questions

What is soft tissue sarcoma?

Soft tissue sarcoma is a rare cancer that grows in soft body parts like muscles, fat, nerves, or blood vessels.

What does 'non-metastatic' mean?

It means the cancer has not spread to other parts of your body from where it first started.

What is a Phase I study?

A Phase I study is the first step in testing a new treatment in people. Its main goal is to check for safety and find the right dose.

Will I get a new medicine?

Yes, you will receive a new investigational drug along with standard treatments for your sarcoma.

Can I stop being in the study if I want to?

Yes, you can choose to leave the study at any time, and this will not affect your medical care.