- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02779257
Pasireotide Treatment for Neuroendocrine Tumor
February 17, 2022 updated by: Kashif Munir, University of Maryland, Baltimore
Pasireotide Treatment for Insulin Producing Pancreatic Neuro-endocrine Tumor
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.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Phase 4
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.
Eligibility Criteria
Ages Eligible for Study
16 years to 73 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- 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
- There are meaningful human clinical data to support an assessment that the potential benefits to patient outweigh risks.
Exclusion Criteria:
- 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 on continuous anticoagulation therapy. Patients who were on anticoagulant therapy must complete a washout period of at least 10 days and have confirmed normal coagulation parameters before study inclusion.
- 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.
QT-related exclusion criteria:.
- 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%
- 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.
- 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.
- Patients with history of liver disease, such as cirrhosis or chronic active hepatitis B or C
- Presence of Hepatitis B surface antigen (HbsAg)
- Presence of Hepatitis C antibody (anti-HCV)
- History of, or current alcohol misuse/abuse within the past 12 months.
- Known gallbladder or bile duct disease, acute or chronic pancreatitis
- Patients with hypomagnesaemia (< 0.7 mmol/L)
- Patients with a history of non-compliance to medical regimens
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
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
|
Pasireotide will be used, in addition to diazoxide, as a medical treatment to blunt hypoglycemia in the setting of autonomous insulin secretion.
Pasireotide will be used, in addition to diazoxide, as a medical treatment to blunt hypoglycemia in the setting of autonomous insulin secretion.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hypoglycemia
Time Frame: up to 12 months
|
number of times glucose < 70 mg/dl with and without symptoms
|
up to 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Kashif M Munir, MD, University of Maryland School of Medicine
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
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 Major Dates
Study Start
April 1, 2016
Primary Completion (Actual)
June 1, 2016
Study Completion (Actual)
June 1, 2016
Study Registration Dates
First Submitted
May 16, 2016
First Submitted That Met QC Criteria
May 17, 2016
First Posted (Estimate)
May 20, 2016
Study Record Updates
Last Update Posted (Actual)
March 4, 2022
Last Update Submitted That Met QC Criteria
February 17, 2022
Last Verified
February 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Neuroendocrine Tumors
- Physiological Effects of Drugs
- Antihypertensive Agents
- Vasodilator Agents
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Diazoxide
- Pasireotide
Other Study ID Numbers
- HP-00069513EU
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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