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Clinical trials

A ‘clinical trial’ is a research study in which people agree to test a potential new treatment to prevent 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 existing treatments.

A.

Clinical trial of Debio 1143 with nivolumab in specific advanced solid tumors

Debiopharm International is conducting an open-label two-part Phase 1b/2 trial in male and female patients with either small cell lung cancer, squamous cell carcinoma of the head and neck, selected gastrointestinal or gynecologic cancers with specific genetic alterations. Tumors with these genetic alterations may respond better to this study treatment. To be eligible, patients must have received at least one prior standard chemotherapy or have no established standard therapeutic alternatives. In addition, patients must have progressed during prior immuno-oncology treatment.

The purpose of Part A is to evaluate increasing doses of Debio 1143 combined with nivolumab to determine the best tolerated dose that can be given to patients in Part B.

Debio 1143 is an investigational medicinal product. Nivolumab is a monoclonal antibody that specifically blocks a target in the body called PD-1 and stimulates the immune system to fight cancer cells.

Debio 1143 is administered orally once daily for 10 consecutive days every 2 weeks. Nivolumab is administered by infusion every 2 weeks.

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B.

Talk with your medical doctor

If you are interested in participating in an upcoming clinical trial, 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 before deciding to participate. When you join a clinical trial, you will still receive care from your primary doctor for your overall health. Most trials are only for a limited time and only pertain to the condition being studied.

C.

Find the trials on the map

A.

Clinical trial of Debio 1143 combined with cisplatin and radiotherapy in head and neck cancer

Debiopharm International is conducting a randomized, double-blind and placebo-controlled Definition This trial is randomized, double-blind and placebo-controlled. Practically, this means that all patients receive carboplatin and paclitaxel but are assigned to Debio 1143 or placebo in a random fashion which means by chance, like tossing a coin, only that a computer system does the tossing according to a mathematical method known as ‘randomization’. Placebo instead of Debio 1143 is given to half of the patients to be able to identify the real effects observed with Debio 1143. As the study is double-blind, neither the patient, nor the investigator and his study team know whether the patient is receiving Debio 1143 or placebo. This is done to ensure that those involved in the management of the trial remain objective in their observations throughout the trial. Phase I/II trial in male and female patients with previously untreated locally advanced squamous cell cancer of the head and neck (oral cavity, oropharynx, hypopharynx and larynx).

The purpose of the Phase II part of this trial is to evaluate the antitumour activity of Debio 1143 Definition Debio 1143 is a small molecule that neutralizes inhibitor of proteins that induce the cell death by mimicking the activity of the natural Second Mitochondrial-derived Activator of Caspases (SMAC).Debio 1143 aims to improve cancer patient treatment outcomes by sensitizing cancer cells to the action of chemotherapy, radiotherapy, and/or immune checkpoint inhibitors. Debio 1143 is a potent orally available IAP inhibitor currently in development in Head and Neck, Ovarian and advanced solid tumors. For more info: http://bit.ly/2xa7RUK – an investigational medicinal product –  in comparison with placebo when added to standard concurrent treatments cisplatin and radiotherapy 1.

The patients undergo three 21-day cycles of cisplatin and radiotherapy combined with Debio 1143 Definition Debio 1143 is a small molecule that neutralizes inhibitor of proteins that induce the cell death by mimicking the activity of the natural Second Mitochondrial-derived Activator of Caspases (SMAC).Debio 1143 aims to improve cancer patient treatment outcomes by sensitizing cancer cells to the action of chemotherapy, radiotherapy, and/or immune checkpoint inhibitors. Debio 1143 is a potent orally available IAP inhibitor currently in development in Head and Neck, Ovarian and advanced solid tumors. For more info: http://bit.ly/2xa7RUK or placebo (a substance having no pharmacological effect). Debio 1143 Definition Debio 1143 is a small molecule that neutralizes inhibitor of proteins that induce the cell death by mimicking the activity of the natural Second Mitochondrial-derived Activator of Caspases (SMAC).Debio 1143 aims to improve cancer patient treatment outcomes by sensitizing cancer cells to the action of chemotherapy, radiotherapy, and/or immune checkpoint inhibitors. Debio 1143 is a potent orally available IAP inhibitor currently in development in Head and Neck, Ovarian and advanced solid tumors. For more info: http://bit.ly/2xa7RUK or placebo is administered as an oral solution on Days 1 to 14 of every cycle in combination with cisplatin administered by infusion on the second day of every cycle and radiotherapy 5 days per week.

In the first part of this trial (Phase I), the highest dose of Debio 1143 Definition Debio 1143 is a small molecule that neutralizes inhibitor of proteins that induce the cell death by mimicking the activity of the natural Second Mitochondrial-derived Activator of Caspases (SMAC).Debio 1143 aims to improve cancer patient treatment outcomes by sensitizing cancer cells to the action of chemotherapy, radiotherapy, and/or immune checkpoint inhibitors. Debio 1143 is a potent orally available IAP inhibitor currently in development in Head and Neck, Ovarian and advanced solid tumors. For more info: http://bit.ly/2xa7RUK that could be safely administered in combination with cisplatin and radiotherapy Definition the standard therapy for this type of cancer was determined. This information was needed to start the Phase II part described above.

1 Clinical Guidelines on esmo.org and nccn.org

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B.

Talk with your medical doctor

If you are interested in participating in an upcoming clinical trial, 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 before deciding to participate. When you join a clinical trial, you will still receive care from your primary doctor for your overall health. Most trials are only for a limited time and only pertain to the condition being studied.

C.

Find the trials on the map

A.

Clinical trial of Debio 1143 with or without cisplatin in patients with resectable squamous cell carcinoma of the head and neck

Debiopharm International is conducting a pre-operative, open-label Definition An open-label trial means that no placebo is administered and that patients know what treatment they are given. , non-randomized “window-of-opportunity” trial in male and female patients with resectable squamous cell cancer of the head and neck (oral cavity, oropharynx, hypopharynx and larynx). A “window-of-opportunity” trial is a trial in which patients receive one or more new compounds between their cancer diagnosis and standard treatment (mainly surgery) to obtain knowledge about the anti-tumor activity of the new agent in a disease state that is not disturbed by previous or simultaneous treatments.

The purpose of this trial is to evaluate the effects of Debio 1143 Definition Debio 1143 is a small molecule that neutralizes inhibitor of proteins that induce the cell death by mimicking the activity of the natural Second Mitochondrial-derived Activator of Caspases (SMAC).Debio 1143 aims to improve cancer patient treatment outcomes by sensitizing cancer cells to the action of chemotherapy, radiotherapy, and/or immune checkpoint inhibitors. Debio 1143 is a potent orally available IAP inhibitor currently in development in Head and Neck, Ovarian and advanced solid tumors. For more info: http://bit.ly/2xa7RUK administered alone or combined with cisplatin Definition the standard therapy for this type of cancer or cisplatin Definition the standard therapy for this type of cancer alone in the above disease in a pre-operative setting. Debio 1143 Definition Debio 1143 is a small molecule that neutralizes inhibitor of proteins that induce the cell death by mimicking the activity of the natural Second Mitochondrial-derived Activator of Caspases (SMAC).Debio 1143 aims to improve cancer patient treatment outcomes by sensitizing cancer cells to the action of chemotherapy, radiotherapy, and/or immune checkpoint inhibitors. Debio 1143 is a potent orally available IAP inhibitor currently in development in Head and Neck, Ovarian and advanced solid tumors. For more info: http://bit.ly/2xa7RUK is an investigational medicinal product. Cisplatin is a drug approved for the treatment of this disease.

A first group patients has already been treated with Debio 1143 Definition Debio 1143 is a small molecule that neutralizes inhibitor of proteins that induce the cell death by mimicking the activity of the natural Second Mitochondrial-derived Activator of Caspases (SMAC).Debio 1143 aims to improve cancer patient treatment outcomes by sensitizing cancer cells to the action of chemotherapy, radiotherapy, and/or immune checkpoint inhibitors. Debio 1143 is a potent orally available IAP inhibitor currently in development in Head and Neck, Ovarian and advanced solid tumors. For more info: http://bit.ly/2xa7RUK alone. A second group of patients will be treated shortly with Debio 1143 Definition Debio 1143 is a small molecule that neutralizes inhibitor of proteins that induce the cell death by mimicking the activity of the natural Second Mitochondrial-derived Activator of Caspases (SMAC).Debio 1143 aims to improve cancer patient treatment outcomes by sensitizing cancer cells to the action of chemotherapy, radiotherapy, and/or immune checkpoint inhibitors. Debio 1143 is a potent orally available IAP inhibitor currently in development in Head and Neck, Ovarian and advanced solid tumors. For more info: http://bit.ly/2xa7RUK combined with cisplatin Definition the standard therapy for this type of cancer or cisplatin Definition the standard therapy for this type of cancer alone until surgery. Debio 1143 Definition Debio 1143 is a small molecule that neutralizes inhibitor of proteins that induce the cell death by mimicking the activity of the natural Second Mitochondrial-derived Activator of Caspases (SMAC).Debio 1143 aims to improve cancer patient treatment outcomes by sensitizing cancer cells to the action of chemotherapy, radiotherapy, and/or immune checkpoint inhibitors. Debio 1143 is a potent orally available IAP inhibitor currently in development in Head and Neck, Ovarian and advanced solid tumors. For more info: http://bit.ly/2xa7RUK is administered orally once daily for 15 days prior to surgery. Cisplatin is administered by infusion on once weekly over 15 days.

  • _Phases

    • P
    • M
B.

Talk with your medical doctor

If you are interested in participating in an upcoming clinical trial, 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 before deciding to participate. When you join a clinical trial, you will still receive care from your primary doctor for your overall health. Most trials are only for a limited time and only pertain to the condition being studied.

C.

Find the trials on the map

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