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Last Updated: October 20, 2019

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CLINICAL TRIALS PROFILE FOR SIGNIFOR LAR KIT

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Clinical Trials for Signifor Lar Kit

Trial ID Title Status Sponsor Phase Start Date Summary
NCT01469572 Pasireotide, Everolimus and Selective Internal Radioembolization Therapy for Unresectable Hepatic Metastases Active, not recruiting Novartis Phase 1 2011-12-01 The purpose of this study is to see the safety and activity of using pasireotide, everolimus and radioembolization (Selective Internal Radioembolization Therapy-SIRT) in the treatment of neuroendocrine tumors (carcinoid) that has spread to the liver. Both everolimus or radioembolization are considered "standard of care" regimens in patients with liver lesions from neuroendocrine tumors. However, the use of the combination of everolimus and radioembolization has not been formally evaluated in the setting of a clinical trial. Pasireotide is a medication that is intended to block the hormonal secretions from the neuroendocrine tumors. This study is divided into two parts. In the first part, the aim of the study is to determine the safety of combining everolimus, pasireotide, and radioembolization. For this part of the study the investigators will enroll up to 18 patients. After the investigators confirm the safety of the combination, they will conduct the second part of the study which will focus on evaluating the effectiveness of the combination. For this part of the study the investigators intend to enroll a total of 37 patients.
NCT01469572 Pasireotide, Everolimus and Selective Internal Radioembolization Therapy for Unresectable Hepatic Metastases Active, not recruiting Emory University Phase 1 2011-12-01 The purpose of this study is to see the safety and activity of using pasireotide, everolimus and radioembolization (Selective Internal Radioembolization Therapy-SIRT) in the treatment of neuroendocrine tumors (carcinoid) that has spread to the liver. Both everolimus or radioembolization are considered "standard of care" regimens in patients with liver lesions from neuroendocrine tumors. However, the use of the combination of everolimus and radioembolization has not been formally evaluated in the setting of a clinical trial. Pasireotide is a medication that is intended to block the hormonal secretions from the neuroendocrine tumors. This study is divided into two parts. In the first part, the aim of the study is to determine the safety of combining everolimus, pasireotide, and radioembolization. For this part of the study the investigators will enroll up to 18 patients. After the investigators confirm the safety of the combination, they will conduct the second part of the study which will focus on evaluating the effectiveness of the combination. For this part of the study the investigators intend to enroll a total of 37 patients.
NCT01620138 Response to Cabergoline and Pasireotide in Non-functioning Pituitary Adenomas and Resistant Prolactinomas Completed Universidade Federal do Rio de Janeiro Phase 2/Phase 3 2010-03-01 There are no available medical treatment options for patients with non-functioning pituitary adenomas (NFPA) or with resistant prolactinomas to dopamine agonists (DA) who are not cured by surgery. The study of the receptors by quantitative messenger ribonucleic acid (mRNA) expression levels and immunohistochemistry analysis might end with a better understanding of these tumors. Besides that, it will be assessed the in vitro and in vivo responses to pasireotide (for NFPA and prolactinomas) and cabergoline (for NFPA). These responses will be compared with the receptor expressions which may be a tool as a predicting element of the response to these compounds.
NCT02527993 Treatment of Hypoglycemia Following Gastric Bypass Surgery Enrolling by invitation Zealand University Hospital Phase 4 2015-10-01 Obesity is increasing worldwide and consequently the need for efficient treatment opportunities. Roux-en-Y gastric bypass (RYGB) is one of the most commonly performed bariatric procedures used in the treatment of severe obesity. The surgery results in significant and sustained weight loss and has a beneficial effect on blood glucose regulation. However, some patients experience the syndrome postprandial hyperinsulinemic hypoglycemia years after the operation, with symptoms varying from mild dizziness to confusion, loss of consciousness and seizures. Larger insulin and glucagon-like peptide 1 (GLP-1) responses to an oral glucose load are believed to play a role in the syndrome, which is not yet fully understood. There are no current treatment guidelines beside dietary recommendations. The purpose of this study is to compare different pharmacological treatments on daily blood glucose variations as well as postprandial hormonal and autonomous changes in subjects with symptoms of postprandial hyperinsulinemic hypoglycemia after RYGB.
NCT02668172 Pasireotide LAR and Pegvisomant Study in Acromegaly Active, not recruiting Novartis Phase 4 2015-08-01 The objective of this study is to assess the efficacy of Pasireotide Long Acting Release (LAR) alone and in combination with weekly Pegvisomant (PEGV) in acromegaIy patients previously controlled with combination treatment of long-acting Somatostatin analogs (LA-SSAs) and PEGV.
NCT02668172 Pasireotide LAR and Pegvisomant Study in Acromegaly Active, not recruiting Erasmus Medical Center Phase 4 2015-08-01 The objective of this study is to assess the efficacy of Pasireotide Long Acting Release (LAR) alone and in combination with weekly Pegvisomant (PEGV) in acromegaIy patients previously controlled with combination treatment of long-acting Somatostatin analogs (LA-SSAs) and PEGV.
NCT02713776 Reduction by Pasireotide of the Effluent Volume in High-output Enterostomy in Patients Refractory to Usual Medical Treatment Not yet recruiting Hospices Civils de Lyon Phase 2 2016-04-01 During rectal or complex digestive surgery with multiple digestive resections and anastomosis, the creation of enterostomy is a common procedure. In France, it is estimated that 20000 patients have an ileostomy and 16000 new digestive stomas are formed each year with approximately 30% of enterostomy. Enterostomy might sometimes give high-output not controlled with usual medical treatment (e.g loperamide ± codeine) and exposes the patients to important hydro-electrolytic loss leading to a risk for dehydration, electrolyte abnormalities and acute renal failure. This risk implies parenteral correction which may extend hospital stay and delay home return. Somatostatin analogues (octreotide, lanreotide and pasireotide) could reduce digestive secretions and decrease digestive peristalsis. Nevertheless, somatostatin analogues are not routinely used for the treatment of patients with high-output enterostomy and their efficacy in the indication (off-label) was only tested in small case series. Pasireotide (SOM230, SIGNIFOR®) is currently indicated for the treatment of patients with Cushing's disease for whom surgery is not an option or for whom surgery has failed. As the efficacity of pasireotide in patients with high-output enterostomy refractory to usual medical treatment associated with an oral fluid restriction has never been demonstrated before, there is a need to perform a pilot, double-blind, randomized, placebo-controlled trial evaluating its impact on reduction of the effluent volume.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Signifor Lar Kit

Condition Name

Condition Name for Signifor Lar Kit
Intervention Trials
Acromegaly 1
Non-functioning Pituitary Adenomas 1
Neuroendocrine Tumors 1
Hypoglycemia, Reactive 1
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Condition MeSH

Condition MeSH for Signifor Lar Kit
Intervention Trials
Hypoglycemia 3
Prolactinoma 1
Pituitary Neoplasms 1
Pituitary Diseases 1
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Clinical Trial Locations for Signifor Lar Kit

Trials by Country

Trials by Country for Signifor Lar Kit
Location Trials
United States 2
Netherlands 1
Brazil 1
Denmark 1
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Trials by US State

Trials by US State for Signifor Lar Kit
Location Trials
Colorado 1
Georgia 1
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Clinical Trial Progress for Signifor Lar Kit

Clinical Trial Phase

Clinical Trial Phase for Signifor Lar Kit
Clinical Trial Phase Trials
Phase 4 3
Phase 2/Phase 3 1
Phase 2 1
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Clinical Trial Status

Clinical Trial Status for Signifor Lar Kit
Clinical Trial Phase Trials
Active, not recruiting 2
Enrolling by invitation 2
Recruiting 1
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Clinical Trial Sponsors for Signifor Lar Kit

Sponsor Name

Sponsor Name for Signifor Lar Kit
Sponsor Trials
Novartis 3
Zealand University Hospital 2
Hospices Civils de Lyon 1
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Sponsor Type

Sponsor Type for Signifor Lar Kit
Sponsor Trials
Other 7
Industry 3
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