Clinical trials
A ‘clinical trial’ is a research study in which a potential new treatment is investigated to prevent, cure or improve a disease or medical condition. A clinical trial also looks at how participants react to the potential new treatment and if any unwanted effects occur. This helps to determine if the new investigational treatment works, is safe, and is better than those that are already available. Many clinical trials also compare existing treatments or test new ways to use or combine with existing treatments.
All new drugs must be tested in clinical trials before they can be prescribed to patients. Without people taking part in these research studies, we would have no new drugs to help others with their condition.
The MYTHIC Clinical Trial to evaluate lunresertib (Debio 2513) in combination with zedoresertib (Debio 0123)
The ‘MYTHIC’ study is a multicenter, open-label Definition Open-label is a type of medical study where both the doctors and the participants know which treatment is being given , Phase 1 study. The study is currently evaluating the safety and efficacy of combining two experimental drugs: lunresertib (Debio 2513) and zedoresertib (Debio 0123). Having successfully completed earlier stages that tested lunresertib individually or in other combinations, researchers are now focused on how lunresertib and zedoresertib work together to fight advanced cancers that have not responded to standard therapies.
Status of the study:
- Modules 1, 2 and 3 (lunresertib in monotherapy and in combination with other agents): Completed.
- Module 4 (lunresertib + zedoresertib): Recruiting.
Inclusion criteria
The study is looking for patients for Module 4 who:
- Are 12 years of age or older (patients under 18 must weigh at least 40kg).
- Have an eligible, locally advanced or metastatic solid tumor with specific genetic markers that has not responded to standard treatment or has returned.
- Are willing to adhere to study plan and procedures.
-
Phases
When a potential new medication is being developed, it is first tested in a laboratory setting. If the results are positive, the drug may enter a clinical trial program. This means that it will be tested in humans in several ‘phases’ of study.
Phase I = Safety evaluation. The very first administration in humans, typically carried out in a small group of healthy volunteers to assess if the drug is safe.
Phase II = Efficacy evaluation. The first trials in patients with the intended disease to check if the drug works efficiently and if there are any unwanted side effects.
Phase III = Confirming findings. Trials in large numbers of patients that generally compare the drug to the best treatments available.
_Phases
- P
- Ⅰ
- Ⅱ
- Ⅲ
- M
Talk with your medical doctor
If you are interested in participating in an upcoming clinical trial (can be also referred to as a clinical study), ask your doctor if a clinical trial might be right for you. Your doctor knows both you and your health history, which is invaluable in making this decision. Your doctor can help you gather the information needed to locate a trial and help you identify what questions might be important to ask the clinical trial doctor before deciding to participate.