Ovarian Cancer

Ovarian cancer is a disease that generally affects women over 40, but especially those over 60. In this form of cancer, certain cells in the ovary become abnormal and multiply uncontrollably to form a tumor.

The most common form of ovarian cancer arises in the epithelial cells on the surface of the ovary. It is also thought that many or even most ovarian cancers begin in epithelial cells at the end of one of the fallopian tubes. Cancer can also begin in epithelial cells that form the lining of the abdomen. This form of cancer is called primary peritoneal cancer. Primary peritoneal cancer often spreads to the ovaries. Because cancers that begin in the ovaries, fallopian tubes, and peritoneum are so similar and spread easily from one of these structures to the others, they are often difficult to distinguish and are so closely related that they are generally considered collectively by experts.

In its early stages, ovarian cancer usually does not cause noticeable symptoms. As the cancer progresses, signs and symptoms can include pain or a feeling of heaviness in the pelvis or lower abdomen, bloating, back pain, vaginal bleeding between menstrual periods or after menopause, or changes in urinary or bowel habits. However, these changes can occur as part of many different conditions. Having one or more of these symptoms does not mean that a woman has ovarian cancer.

Because it is often diagnosed at a late stage, ovarian cancer can be difficult to treat. However, when it is diagnosed and treated early, the 5-year survival rate is high.

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 combined with carboplatin and paclitaxel in ovarian cancer

Debiopharm International is conducting a randomized, double-blind, placebo Definition a substance having no pharmacological effect -controlled 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

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.

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External links related to this pathology

Ovarian Cancer Action

Ligue contre le cancer

European Patients’ Academy

American Cancer Society

Cancer Research UK

EudraCT

World Health Organization

National Cancer Institute

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

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