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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.

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Clinical trial of Debio 1143 combined with carboplatin and paclitaxel in ovarian cancer

Debiopharm International is conducting a randomized, double-blind, 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 II trial in patients with newly diagnosed, high grade serous ovarian cancer and high-grade endometrioid ovarian cancer, fallopian tube carcinoma or primary peritoneal carcinoma.
The purpose of this study is to assess in this population the antitumor activity before surgery 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 combination with paclitaxel and carboplatin Definition the standard therapy for this type of cancer 1.
The patients undergo four 21-day cycles of pre-surgery chemotherapy with carboplatin and paclitaxel 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 Definition a substance having no pharmacological effect followed by surgery of the tumor. After surgery, patients receive therapy as per the investigator’s choice. 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 Definition a substance having no pharmacological effect is administered orally as capsules once daily on Days 1 to 5 of every cycle in combination with paclitaxel and carboplatin Definition the standard therapy for this type of cancer each administered by infusion on the first day of every cycle.

1 Clinical Guidelines on esmo.org and nccn.org

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