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Signifor (Pasireotide) - Summary



SIGNIFOR (pasireotide) is a somatostatin analog.

Cushing’s Disease

SIGNIFOR is indicated for the treatment of adult patients with Cushing’s disease for whom pituitary surgery is not an option or has not been curative.

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Published Studies Related to Signifor (Pasireotide)

Hepatic xanthoma associated with pasireotide administration: a first case report. [2013]
Hepatic xanthoma is an extremely rare lesion worldwide. We herein present a case of hepatic xanthoma that developed in a 27-year-old Taiwanese man who had participated in a clinical trial of pasireotide...

Safety, tolerability, pharmacokinetics, and pharmacodynamics of a long-acting release (LAR) formulation of pasireotide (SOM230) in patients with gastroenteropancreatic neuroendocrine tumors: results from a randomized, multicenter, open-label, phase I study. [2013]
neuroendocrine tumor (GEP NET) refractory to other SSAs... CONCLUSIONS: This study demonstrated that a new, once-monthly, intramuscular LAR

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Clinical Trials Related to Signifor (Pasireotide)

Somatostatin Analogue SOM230 (Pasireotide) in Healthy Male Volunteers [Completed]
This clinical study will attempt to find out why in early studies in healthy volunteers, injections under the skin of pasireotide were associated with temporary increases in both fasting and post-meal glucose levels, along with possible increases in insulin and glucagon levels. Glucose refers to the amount of sugar in your blood and insulin and glucagon levels are amounts of hormones that lower and raise blood sugar. The purpose of the study is to evaluate the effects of pasireotide on insulin resistance and secretion. Insulin is a natural hormone made by the pancreas (a gland inside the abdomen) that controls the level of sugar in the blood. Insulin permits cells to use sugar for energy. Insulin resistance is the condition in which higher than normal amounts of insulin are necessary to allow the sugar to enter the cells. Insulin secretion refers to the amount of insulin produced by the body and released in the blood. Glucagon is a hormone (chemical substance produced by the pancreas gland in the body) which increases blood glucose.

Study to Allow Access to Pasireotide for Patients Benefiting From Pasireotide Treatment in a Novartis-sponsored Study. [Recruiting]
The purpose of this study is to allow continued use of pasireotide in patients who are on pasireotide treatment in a Novartis-sponsored, Oncology Clinical Development & Medical Affairs (CD&MA) study and are benefiting from the treatment as judged by the investigator.

Phase II Trial of SOM230 in Patients With Unresectable Hepatocellular Carcinoma [Recruiting]
The hypothesis of this clinical trial is that hepatocellular carcinomas contain somatostatin receptors which make them sensitive to the inhibitory effects of a new somatostatin analog, SOM230. This analog has greater and broader binding affinity to somatostatin receptors compared to the current drug in use, sandostatin LAR. Thus, SOM230 has the potential to be more effective in the treatment of patients with hepatocellular carcinoma.

Placebo Controlled Trial of SOM230 for the Reduction of Post-Pancreatectomy Fistula, Leak, and Abscess [Completed]
The purpose of this study is to help us learn more about how to lower the patient's risk of the most common complications after their pancreas operation. After tumors are removed and the remaining part of the pancreas is connected to the intestine or closed, a leakage of pancreatic fluid may occur. This fluid may form an "abscess" (collection of pus) or "fistula" that would need to be drained. A fistula is a persistent leakage of pancreatic fluid that sometimes occurs after pancreatic surgery. Fistulas, leaks, and abscesses are complications that are seen in roughly every 15-20 patients out of every 100 that have pancreas surgeries. Complications like these extend the patient's stay in the hospital after surgery. These complications may require the patient's doctor to perform additional tests or procedures to treat them. The physical and emotional burden these complications place upon patients, as well as the financial cost to the health care system, can be great. The surgeons at Memorial Sloan-Kettering Cancer Center are conducting a study to determine if a drug, SOM230, can help reduce the rate of these complications. SOM230, also known as Pasireotide, is a drug that has been observed to reduce the rate of similar complications in other studies. The surgeon would like to compare the effects, good and/or bad, of SOM230 with "placebo" (solution without medication) to see if SOM230 reduces the rate of fistulas, leaks and abscesses.

A Trial of Pasireotide and Everolimus in Adult Patients With Radioiodine-Refractory Differentiated and Medullary Thyroid Cancer [Recruiting]
The purpose of this study is to determine the effectiveness of two anticancer drugs, everolimus and pasireotide, in patients with thyroid cancer when the cancer is no longer responding to treatment with radioiodine or where it is deemed unsafe for the patient to receive additional radioiodine treatment. The investigators also want to establish the best manner of taking the two medications when used together to treat thyroid cancer. In particular, the investigators want to know if it is better to give both at the same time or add a second medication after the first one has stopped working. This study will also look at specific substances called biomarkers in your blood, and in the tumor tissue which are involved in the growth of tumor cells, and determine if the levels of these biomarkers are related to your response to treatment or development of side effects. Everolimus, also known by the brand name, Afinitor, is a biologic drug approved by the Food and Drug Administration (FDA) for the treatment of kidney cancer. It works by preventing cancer cells from multiplying and it also makes them more likely to die from the treatment. Pasireotide also known by the name, SOM230 is a new medication that is not yet approved by the FDA for the treatment of cancer. It is a newer form of a drug called octreotide, which is approved for the treatment of cancer arising from endocrine organs. Pasireotide works by binding to a protein called somatostatin receptor, which is expressed in many tissues throughout the body including thyroid cancer cells. Pasireotide prevents the action of somatostatin by binding to these receptors.

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Page last updated: 2015-08-10

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