EPITOME-1015-I: A phase I study to investigate the safety and tolerability of MDG1015 in patients with epithelial ovarian cancer, gastroesophageal adenocarcinoma, round cell liposarcoma and/or synovial sarcoma
This study, called EPITOME-1015-I, is a very early stage trial, meaning it's the first time the new medicine MDG1015 is being given to people. The main goal is to check if MDG1015 is safe and how well patients can tolerate it. It's designed for people with specific types of cancer: epithelial ovarian cancer, a type of stomach or food pipe cancer (gastroesophageal adenocarcinoma), or two types of rare soft tissue cancers called myxoid (round cell) liposarcoma or synovial sarcoma. This early research helps doctors understand how a new treatment works in the body before it can be studied in larger groups of people.
At a glance
What is this study about?
This research study, known as EPITOME-1015-I, is an early step in testing a new medicine called MDG1015. When a new medicine is developed, it goes through several stages of testing. This is a 'Phase I' study, which means it's the very first time this medicine is being given to people. The main purpose of this initial stage is to find out if the medicine is safe and what dose can be given without causing too many side effects. It’s not primarily about seeing how effective the drug is at treating cancer at this stage, but understanding its safety profile.
The study involves people who have certain types of cancer. These include epithelial ovarian cancer, which is a common type of ovarian cancer, and gastroesophageal adenocarcinoma, which affects the stomach or the tube connecting your mouth to your stomach (oesophagus). It also includes two rarer types of cancer called myxoid (round cell) liposarcoma and synovial sarcoma, which are types of soft tissue cancers.
By carefully studying how MDG1015 acts in the body and if it causes any unwanted effects, researchers can decide if it's safe to continue testing in larger studies. This kind of early research is crucial for developing new cancer treatments, although it’s important to remember that not all new treatments prove to be effective or safe enough.
Key takeaways
- This is a very early study of a new cancer medicine, MDG1015.
- The main aim is to check the medicine's safety and how well people tolerate it.
- It's for specific types of ovarian, stomach/gullet, and soft tissue cancers.
- Participation involves regular hospital visits for tests and to receive the medication.
- There are potential benefits (access to new treatment) and potential risks (unknown side effects).
- You can stop participating at any time without affecting your normal care.
Who may be eligible?
To join this study, participants must be at least 18 years old. There is no upper age limit, meaning older adults can also take part. The study is open to both men and women.
Participants must have been diagnosed with one of the specific types of cancer being studied: epithelial ovarian cancer, gastroesophageal adenocarcinoma (cancer of the stomach or where the stomach meets the food pipe), myxoid (round cell) liposarcoma, or synovial sarcoma.
Further specific health checks will be done by the study doctors to make sure it's safe for you to take part. This includes reviewing your medical history, current health, and any other medications you might be taking.
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 at least 18 years old?
- Do you have epithelial ovarian cancer, gastroesophageal adenocarcinoma, myxoid (round cell) liposarcoma, or synovial sarcoma?
- Are you able to commit to regular hospital visits and follow-up?
- Are you prepared for the possibility of unknown side effects from a new medicine?
What does participation involve?
Taking part in this early-stage study typically involves regular visits to the hospital or clinic. During these visits, you will have various tests to check your health, such as blood tests, scans, and physical examinations. This is to monitor how your body is reacting to the new medicine and to check for any side effects. You will receive the study medicine, MDG1015, as instructed by the study team.
The initial part of a Phase I study often involves frequent visits, potentially several times a week, as the researchers carefully increase the dose of the medicine for different groups of patients. The total duration of your participation will depend on how you respond to the treatment and the design of the study, and will be explained in detail by the study team. There will likely be a follow-up period after you finish taking the medicine to continue monitoring your health.
Potential risks and benefits
Locations (1)
- —UnverifiedNetherlands
Common questions
What is the main goal of this study?
The main goal is to check if the new medicine, MDG1015, is safe for people and what dose can be given without causing too many problems.
What type of medicine is MDG1015?
MDG1015 is a new, experimental medicine being tested for specific types of cancer. We are still learning how it works.
Will this medicine cure my cancer?
This early study primarily focuses on safety, not on curing cancer. While there's a chance it could help, we won't know about its effectiveness until later stages of research.
How long will I be in the study if I join?
The total length of time you'd be involved will vary and will be fully explained by the study team, typically involving regular visits for a period and then follow-up.
Can I stop being part of the study at any time?
Yes, you can choose to leave the study at any point, and this won't affect your regular medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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