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RecruitingPHASE1INTERVENTIONAL

Study of Sacituzumab Govitecan in Participants With Advanced or Metastatic Solid Tumor and Moderate Liver Impairment

This study is investigating a new medication called sacituzumab govitecan for individuals suffering from advanced or spreading cancer, particularly those who also have moderate liver difficulties. The main goals are to determine the safest and most effective dose of this new drug. Researchers are also keen to learn more about how the body handles the medicine and any side effects it might cause. This is a very early-stage study, often called a Phase 1 trial, meaning it's one of the first times this drug is being tested in a larger group of people to understand its potential. Participants will have regular check-ups to monitor their health throughout the study.

At a glance

Status
Recruiting
Phase
PHASE1
Sponsor
Gilead Sciences
Enrolment target
30
Start
06 Apr 2021
Estimated completion
01 Dec 2026

What is this study about?

This research is looking at a new medicine called sacituzumab govitecan, which is being tested for people who have advanced cancer that has either spread or is difficult to treat. What makes this study particularly important is its focus on patients who also have some problems with their liver function. Our liver plays a crucial role in processing medicines, so it's vital to understand how new drugs behave in people whose livers might not be working perfectly.

The main aim of this study is to find the right dose of sacituzumab govitecan that is both safe and has the best chance of helping patients with advanced cancer and moderate liver issues. Researchers will also be carefully monitoring how the body absorbs, uses, and gets rid of the medicine, and looking out for any side effects. This information will help doctors in the future to correctly prescribe this treatment to more patients if it proves to be effective.

This is a 'Phase 1' study, which means it's an early step in testing a new treatment. These types of studies are essential for gathering basic safety information and figuring out the correct dose before the drug can be tested in larger groups of people. Every step of the study is carefully planned to keep participants safe and to gather reliable information about this potential new cancer treatment.

Key takeaways

  • This study is for advanced or spreading solid cancers.
  • It's testing a new drug for people who also have moderate liver problems.
  • The main goal is to find a safe and effective dose of the new treatment.
  • Your general health and blood counts need to be within certain limits to join.
  • It's a Phase 1 study, focusing on early safety and dosing information.

Who may be eligible?

To join this study, you would need to have cancer that has spread or is advanced, and doctors must be able to measure or see your cancer. Generally, you should be able to carry out your daily activities with little to no difficulty. Your blood counts (like red blood cells, white blood cells, and platelets) need to be at a healthy level without needing recent blood transfusions or special injections to boost them. Your kidney function also needs to be working well enough.

For most people taking part, your liver function would need to be within a normal range. However, this study specifically includes a group of people with moderate liver problems. If you have moderate liver problems, your liver test results would show certain changes, but you must still be able to understand and agree to take part in the study, even if you have a condition called 'hepatic encephalopathy' which can sometimes affect thinking.

There are also some reasons why you wouldn't be able to join. For example, if you have very poor veins, have recently donated a lot of blood, or have had other cancer treatments (like chemotherapy or radiation) very recently. Also, if you have another active cancer or if your cancer has spread to your brain in certain ways, you might not be able to participate. Your study doctor will go through all these details with you carefully.

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.

  1. Do I have advanced or spreading solid cancer?
  2. Do I generally feel well enough to do my daily activities?
  3. Have my doctor's tests shown I have healthy blood counts?
  4. Do I have moderate liver problems, or is my liver function normal?
  5. Have I avoided recent chemotherapy, radiation, or other cancer treatments in the last few weeks?
  6. Do I understand what it means to give my consent to join the study?
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 drug, sacituzumab govitecan, as an injection. The study team will carefully monitor your health throughout. This will involve regular visits to the clinic for check-ups, which might include blood tests, physical examinations, and scans to see how you are responding to the treatment and to check for any side effects. The exact number of visits and tests will be explained to you by the study team. You will be closely followed to ensure your safety and that the treatment is working as intended. The total length of your participation will depend on how you respond to the treatment and the study plan, but ongoing monitoring will be a key part of your involvement.

Potential risks and benefits

Like all medical treatments, taking part in this study might offer potential benefits, such as access to a new treatment that isn't widely available yet, which could help your cancer. However, there are also potential risks, including side effects from the study drug. These will be fully explained to you by the research team. You are always free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (15)

  • Pacific Shores Medical Group
    Verified postcode
    Long Beach, United States· Suspended
  • Christiana Care Health Services
    Verified postcode
    Newark, United States· Recruiting
  • University of Maryland
    Verified postcode
    Baltimore, United States· Recruiting
  • NEXT Austin
    Verified postcode
    Austin, United States· Withdrawn
  • Oncology Consultants, P.A.
    Verified postcode
    Houston, United States· Recruiting
  • The University of Texas M.D. Anderson Cancer Center
    Verified postcode
    Houston, United States· Recruiting
  • Texas Liver Institute
    Verified postcode
    San Antonio, United States· Recruiting
  • NEXT Oncology
    Verified postcode
    San Antonio, United States· Recruiting
  • Institut Bergonie Medical Oncology
    Verified postcode
    Bordeaux, France· Recruiting
  • Centre Leon Berard
    Verified postcode
    Lyon, France· Recruiting
  • Institut de Cancerologie de l'Ouest (ICO) - Saint-Herblain
    Verified postcode
    Saint-Herblain, France· Recruiting
  • Instituto Europeo di Oncologia
    Verified postcode
    Milan, Italy· Recruiting

Common questions

What kind of cancer is this study for?

This study is for people with advanced or spreading solid cancers, meaning cancers that form solid tumours in the body.

What does 'moderate liver problems' mean for this study?

It means your liver function tests show specific changes, confirming your liver isn't working as well as it should, but it's not severely damaged.

Will I get paid to be in this study?

The study does not typically offer payment, but you should discuss with the study team if any travel or other expenses will be covered.

How long will I be in the study?

The length of your participation will depend on your health and how your body responds to the treatment. The study team will explain this to you.

Will I still get my regular medical care if I join?

Yes, taking part in the study does not stop you from receiving your usual medical care alongside the study treatment.

How to find out more

Gilead Clinical Study Information Center

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

Interested in taking part?

Register your interest

Share your details and the research team for "Study of Sacituzumab Govitecan in Participants With Advanced…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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