Ongoing, recruitingPhase I and Phase II (Integrated)- OtherInterventional

Phase 1b/2 study of liposomal annamycin (l-annamycin) in patients with previously treated metastatic soft-tissue sarcomas (ANNA-SARC)

This research study is investigating a new medication, liposomal annamycin, for people with advanced soft-tissue sarcomas. These are rare cancers that start in soft tissues like muscle or fat. The patients in this study will have already tried other treatments that didn't work. The study has two main parts. The first part will help doctors find the safest and most effective dose of this new drug. The second part will then look at how many patients see their cancer stop growing for at least three months after taking the medication. Researchers will also be checking the overall response to the treatment, how long people live, and whether surgery becomes an option for some patients.

At a glance

Status

Ongoing, recruiting

Phase

Phase I and Phase II (Integrated)- Other

Sponsor

Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy

Enrolment target

Start

11 Jan 2025

METASTATIC SOFT-TISSUE SARCOMAS AFTER FAILURE ON AT LEAST ONE SYSTEMIC THERAPY

What is this study about?

This study is about a new medicine called liposomal annamycin (often shortened to l-annamycin) that is being tested for people who have a type of cancer called metastatic soft-tissue sarcoma. 'Metastatic' means the cancer has spread from where it started to other parts of the body. 'Soft-tissue sarcomas' are rare cancers that can begin in different soft tissues, such as muscles, fat, blood vessels, or nerves anywhere in the body. The patients taking part in this study will have already tried at least one other treatment for their cancer that didn't work as well as hoped.

The study has two main goals. The first part, called Phase 1b, is about finding the best and safest dose of l-annamycin for patients. Once that dose is found, the second part, Phase 2, will look at how well the new medicine works. Specifically, it will measure how many patients find that their cancer stops growing for at least three months after starting the treatment. Doctors will also be looking at other important things, like how much the tumours shrink, how long patients live, and if the treatment makes it possible for some patients to have surgery.

The main reason for doing this study is to see if l-annamycin could be a new and effective treatment option for people with advanced soft-tissue sarcomas when other treatments haven't been successful. Finding new ways to treat these cancers is essential to improve patients' lives and outcomes.

Key takeaways

This study is testing a new drug for advanced soft-tissue sarcomas.
It's for people whose cancer has spread and hasn't responded to previous treatments.
The study aims to find the right dose and see how well the treatment stops cancer growth.
Participation involves regular hospital visits for assessments and treatment.
You will be closely monitored for both benefits and side effects.
You can stop participating at any time.

Who may be eligible?

To be considered for this study, you must be at least 18 years old. Both men and women are welcome to take part.

Crucially, you would need to have been diagnosed with metastatic soft-tissue sarcoma, meaning your cancer has spread. You must also have already received and not responded well to at least one previous treatment for your cancer.

There will be other specific medical checks to make sure this study is safe and suitable 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?
Do you have metastatic soft-tissue sarcoma (cancer that has spread)?
Have you already tried at least one other cancer treatment that didn't work as hoped?
Are you able to attend regular hospital appointments for treatment and check-ups?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive the study medicine, liposomal annamycin. The study is split into two phases. In the first phase, if you are among the first patients, doctors will carefully adjust the dose to find the most effective and safest amount. In the second phase, you will receive the dose that was determined in the first phase.

You will need to attend regular clinic visits for examinations, blood tests, and scans (like CT or MRI scans) to check how you are responding to the treatment and to monitor for any side effects. These scans will help determine if the cancer is shrinking, staying the same, or growing. You'll also be asked about your general well-being and any symptoms you might have. The total duration of your participation will depend on how you respond to the treatment and the study's follow-up schedule.

Potential risks and benefits

Taking part in any clinical trial has potential benefits and risks. A potential benefit of this study is that you might receive a new treatment that could help control your cancer when other treatments haven't worked. Your health will also be closely monitored by a dedicated medical team. However, there are potential risks, and the new medicine might cause side effects, some of which could be serious. The treatment may also not work for you, or your cancer could continue to grow. You will be given a full explanation of all known side effects before you decide to join. Remember, taking part in this study is entirely voluntary, and you are free to withdraw at any time without giving a reason, and your medical care will not be affected.

Locations (1)

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

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Unverified
Poland

Common questions

What is a soft-tissue sarcoma?

It's a rare type of cancer that starts in soft tissues of the body, like muscles, fat, blood vessels, or connective tissues.

What does 'metastatic' mean?

It means the cancer has spread from where it first started to other parts of your body.

What is liposomal annamycin?

It's a new medicine being tested in this study to see if it can treat advanced soft-tissue sarcomas.

What does 'Phase 1b/2 study' mean?

It means the study is in two main parts: first, finding the right dose of the new drug (Phase 1b), and then checking how well it works (Phase 2).

Will I get this new medicine if I join?

Yes, if you meet all the study requirements, you would receive the new medicine being tested.