Pasireotide Treatment for Neuroendocrine Tumor

NCT02779257 | Withdrawn Phase 4

• 1 other identifier: HP-00069513EU
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Pasireotide binds to somatostatin receptors sst2 and sst5, which can lead to significant hyperglycemia. The investigators would like to administer pasireotide as a treatment for refractory hypoglycemia in the setting of metastatic insulin-producing pancreatic neuro-endocrine tumor.

Conditions

Gastro-enteropancreatic Neuroendocrine Tumor

Keywords

hypoglycemia

Outcome Measures

Primary Outcomes (1)

• Hypoglycemia

  number of times glucose \< 70 mg/dl with and without symptoms

  up to 12 months

Study Arms (1)

Pasireotide

EXPERIMENTAL

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

Drug: Pasireotide; Drug: Diazoxide

Interventions

Pasireotide DRUG

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

Pasireotide

Diazoxide DRUG

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

Pasireotide

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 years or older
• Biopsy-proven (primary or metastatic lesion) metastatic neuroendocrine tumor of the gastrointestinal and pancreatic location with disease determined by CT scan or MRI
• Patients with history of clinical syndrome symptoms (e.g. hypoglycemia)
• Patients not controlled by treatment with currently available somatostatin analogues.
• No evidence of significant liver disease:
• Serum bilirubin ≤1.5 x ULN
• INR \< 1.3
• ALT and AST ≤ 3x ULN,
• Alkaline phosphatase ≤ 2.5 x ULN
• Written informed consent obtained prior to treatment to be consistent with local regulatory requirements
• Is suffering from a serious or life-threatening disease or condition
• Does not have access to a comparable or satisfactory alternative treatment (i.e., comparable or satisfactory treatment is not available or does not exist)
• 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
• Meets any other relevant medical criteria for compassionate use of the investigational product
• Is not being transferred from an ongoing clinical trial for which they are still eligible

You may not qualify if:

• Patients with a known hypersensitivity to somatostatin analogs or any component of the pasireotide LAR or s.c. formulations.
• Patients with abnormal coagulation (PT or aPTT elevated by 30% above normal limits).
• Patients currently using warfarin / warfarin derivatives
• Patients with symptomatic cholelithiasis.
• Patients who are not biochemically euthyroid. Patients with known history of hypothyroidism are eligible if they are on adequate and stable replacement thyroid hormone therapy for at least 3 months.
• 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
• Patients who have any severe and/or uncontrolled medical conditions :
• Uncontrolled diabetes as defined by HbA1c \> 8%

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• Novartis: collaborator

Related Publications (1)

• Tirosh A, Stemmer SM, Solomonov E, Elnekave E, Saeger W, Ravkin Y, Nir K, Talmor Y, Shimon I. Pasireotide for malignant insulinoma. Hormones (Athens). 2016 Apr;15(2):271-276. doi: 10.14310/horm.2002.1639.

  PMID: 26732164 BACKGROUND

MeSH Terms

Conditions

Gastro-enteropancreatic neuroendocrine tumor; Hypoglycemia

Interventions

pasireotide; Diazoxide

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Benzothiadiazines; Sulfonamides; Sulfones; Sulfur Compounds; Organic Chemicals; Thiazides; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Kashif M Munir, MD

  University of Maryland, Baltimore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: May 16, 2016
• First Posted: May 20, 2016
• Study Start: April 1, 2016
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: March 4, 2022

Record last verified: 2022-02