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.
Clinical trial of Debio 0123 in combination with carboplatin in patients with advanced solid tumors
The Debio 0123-101 study is an open-label Definition Open-label is a type of medical study where both the doctors and the participants know which treatment is being given , multi-center clinical study evaluating an experimental drug (Debio 0123) administered in combination with a common chemotherapeutic agent called carboplatin, in patients with advanced solid tumors.
The Debio 0123-101 study is divided into 2 parts.
In Part 1 – Dose Escalation
Debio 0123 was given at different doses and with 2 different schedules. The objective was to find the best dose and schedule. Part 1 is now completed.
Part 2 – Dose Expansion
is still ongoing with the objective of confirming the optimal dose and schedule selected in Part 1. This will be done by assessing the side effects of Debio 0123 and its possible effect on the tumor when combined with carboplatin. Part 2 will also explore the way the drugs work and are processed in the human body.
Part 1 inclusion criteria
- patients with locally advanced or metastatic solid tumors whose disease had progressed despite platinum-based therapy.
Part 2 inclusion criteria
- Patients with a certain type of locally advanced or metastatic solid tumors.
- Whose cancer progressed within the first 6 months of completion of their most recent platinum-based chemotherapy regimen.
- Who were able and willing to adhere to study plan and procedures (including biopsies) and use effective birth control methods.
About Debio 0123
Cancer cells generally grow quickly and accumulate DNA damage over time. Too much DNA damage could cause the cells to die when they divide to form new cells. Therefore, many cancer cells take advantage of cell machinery, which allows time to repair this damage, so they can continue to multiply and survive.
The drug being investigated in this study, Debio 0123, prevents the cells from repairing their damaged DNA. As such, it is believed that it may help kill cancer cells and reduce tumor size.
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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.
Clinical trial of Debio 0123 as a standalone treatment (monotherapy) in adult patients with different tumor types
The Debio 0123-102 study is an open-label Definition Open-label is a type of medical study where both the doctors and the participants know which treatment is being given. , multi-center clinical study evaluating an experimental drug (Debio 0123) used as a standalone treatment (monotherapy) in adult patients with different tumor types.
The Debio 0123-102 study is divided into 2 parts.
Part 1 – Dose Escalation
involved patients with advanced-stage cancers. The objective was to find the best dose of Debio 0123. Part 1 is now completed.
Part 2 – Dose Expansion
is still ongoing with the objective of confirming the dose selected in Part 1. This will be done by assessing the side effects of Debio 0123 and its possible effect on the tumor. Part 2 will also explore the way the drug works and is processed in the human body.
Part 2 will focus on patients with:
- Arm A: uterine serous carcinoma (a more aggressive and less common form of endometrial cancer),
- Arm B: gynecological tumors with specific alterations (epithelial ovarian cancer, primary peritoneal cancer, fallopian tube cancer), and
- Arm C: locally advanced or metastatic solid tumors with specific alterations.
Part 1 inclusion criteria
- Patients with locally advanced or metastatic solid tumors
- Whose disease had progressed despite therapy or for which no therapy of proven benefit was available.
Part 2 inclusion criteria
- You have one of the tumor types mentioned above for Arms A, B or C that is progressing or recurring after previous therapy.
- You have adequate bone marrow, liver biochemistry, renal function, and coagulation capabilities.
- You are able and willing to adhere to study plan and procedures (including biopsies) and use effective contraceptive methods.
About Debio 0123
Cancer cells generally grow quickly and accumulate DNA damage over time. Too much DNA damage could cause the cells to die when they divide to form new cells. Therefore, many cancer cells take advantage of cell machinery, which allows time to repair this damage, so they can continue to multiply and survive.
The drug being investigated in this study, Debio 0123, prevents the cells from repairing their damaged DNA. As such, it is believed that it may help kill cancer cells and reduce tumor size.
-
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.