Pasireotide Treatment For Neuroendocrine Tumor

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2016-05-16	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2022-02-17
First Submitted that Met QC Criteria 2016-05-17	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2022-03-04
First Posted (ACTUAL) 2016-05-20	Results First Posted N/A	Last Verified 2022-02

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Pasireotide Off label use of pasireotide to treat refractory hypoglycemia due to an insulin-producing pancreatic neuroendocrine tumor	DRUG: Pasireotide Pasireotide will be used, in addition to diazoxide, as a medical treatment to blunt hypoglycemia in the setting of autonomous insulin secretion. DRUG: Diazoxide Pasireotide will be used, in addition to diazoxide, as a medical treatment to blunt hypoglycemia in the setting of autonomous insulin secretion.

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Pasireotide

Off label use of pasireotide to treat refractory hypoglycemia due to an insulin-producing pancreatic neuroendocrine tumor

DRUG: Pasireotide

Pasireotide will be used, in addition to diazoxide, as a medical treatment to blunt hypoglycemia in the setting of autonomous insulin secretion.

DRUG: Diazoxide

Pasireotide will be used, in addition to diazoxide, as a medical treatment to blunt hypoglycemia in the setting of autonomous insulin secretion.

Primary Outcome Measures	Measure Description	Time Frame
Hypoglycemia	number of times glucose < 70 mg/dl with and without symptoms	up to 12 months

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
MALE

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Serum bilirubin ≤1.5 x ULN
INR < 1.3
ALT and AST ≤ 3x ULN,
Alkaline phosphatase ≤ 2.5 x ULN 6. Written informed consent obtained prior to treatment to be consistent with local regulatory requirements 7. Is suffering from a serious or life-threatening disease or condition 8. Does not have access to a comparable or satisfactory alternative treatment (i.e., comparable or satisfactory treatment is not available or does not exist) 9. Is not eligible for participation in any of the IMP's ongoing clinical trials or has recently completed a clinical trial that has been terminated and, after considering other options (e.g., trial extensions, amendments, etc.), the clinical team has determined that treatment is necessary and there are no other feasible alternatives for the patient 10. Meets any other relevant medical criteria for compassionate use of the investigational product 11. Is not being transferred from an ongoing clinical trial for which they are still eligible 12. There are meaningful human clinical data to support an assessment that the potential benefits to patient outweigh risks.

QTcF at screening >450 msec in males, and > 460 msec in females.
Family history of idiopathic sudden death
Sustained or clinically significant cardiac arrhythmias
Risk factors for Torsades de Pointes such as hypokalemia, hypomagnesemia, cardiac failure, clinically significant/symptomatic bradycardia, or high-grade AV block
Concomitant disease(s) that could prolong QT such as autonomic neuropathy (caused by diabetes, or Parkinson's disease), HIV, cirrhosis, uncontrolled hypothyroidism or cardiac failure
Family history of long QT syndrome
Concomitant medications known to prolong the QT interval.
Potassium < or = 3.5 mmol/L 8. Patients who have any severe and/or uncontrolled medical conditions :

Uncontrolled diabetes as defined by HbA1c > 8%
Patients with the presence of active or suspected acute or chronic uncontrolled infection or with a history of immunodeficiency, including a positive HIV test result (ELISA and Western blot). An HIV test will not be required; however, previous medical history will be reviewed.
Non-malignant medical illnesses that are uncontrolled or whose control may be jeopardized by the treatment with this study treatment.
Life-threatening autoimmune and ischemic disorders. 9. Patients who have a history of another primary malignancy, with the exception of locally excised non-melanoma skin cancer and carcinoma in situ of uterine cervix. Patients who have had no evidence of disease from another primary cancer for 1 or more years are allowed to participate in the study. 10. Patients with history of liver disease, such as cirrhosis or chronic active hepatitis B or C 11. Presence of Hepatitis B surface antigen (HbsAg) 12. Presence of Hepatitis C antibody (anti-HCV) 13. History of, or current alcohol misuse/abuse within the past 12 months. 14. Known gallbladder or bile duct disease, acute or chronic pancreatitis 15. Patients with hypomagnesaemia (< 0.7 mmol/L) 16. Patients with a history of non-compliance to medical regimens 17. If the patient is a sexually active male he is excluded unless he agrees to use a condom during intercourse while taking pasireotide and for 3 months after stopping pasireotide medication. They should not father a child in this period. A condom is required to be used also by vasectomized men in order to prevent delivery of the drug via seminal fluid

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