Gastro-enteropancreatic Neuroendocrine TumorPhase 4NCT02779257
Pasireotide Treatment for Neuroendocrine Tumor
A Phase 4 study testing Pasireotide and Diazoxide in people with Gastro-enteropancreatic Neuroendocrine Tumor, run by University of Maryland, Baltimore.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, men only
- Conditions the study is for
- Gastro-enteropancreatic Neuroendocrine Tumor
- What is being tested?
- Pasireotide and Diazoxide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Apr 2016to Jun 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
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- 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
About this study
Official title: 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.
- Being tested
- Pasireotide, Diazoxide
- Keywords
- hypoglycemia
- Medical subject headings
- Gastro-enteropancreatic neuroendocrine tumor, Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PasireotideDrug
Pasireotide will be used, in addition to diazoxide, as a medical treatment to blunt hypoglycemia in the setting of autonomous insulin secretion.
DiazoxideDrug
Pasireotide will be used, in addition to diazoxide, as a medical treatment to blunt hypoglycemia in the setting of autonomous insulin secretion.
| Study group | Role | What they receive |
|---|---|---|
| Pasireotide | Experimental | Off label use of pasireotide to treat refractory hypoglycemia due to an insulin-producing pancreatic neuroendocrine tumor Receives: Drug: Pasireotide; Drug: Diazoxide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypoglycemia
number of times glucose < 70 mg/dl with and without symptoms
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2016 (estimated)
- Study startApr 2016
- Primary completionJun 2016
- Study completionJun 2016
Why it stopped: Subject passed away prior to enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastro-enteropancreatic Neuroendocrine TumorStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis
- Responsible party
- Principal investigator, Kashif Munir, University of Maryland, Baltimore
- Investigators
- Kashif M Munir, MD, Principal investigator, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02779257
- Sponsor's protocol ID
- HP-00069513EU
- Status last verified
- Feb 2022
- First submitted
- 16 May 2016
- Last updated
- 4 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26732164
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pasireotide Treatment for Insulin Producing Pancreatic Neuro-endocrine Tumor
- ClinicalTrials.gov ID
- NCT02779257
- Acronym / sponsor ID
- HP-00069513EU
- Keywords
- hypoglycemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Subject passed away prior to enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- Novartis
- Study start
- Apr 2016
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 20 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pasireotide | Experimental | Drug: Pasireotide, Drug: DiazoxideOff label use of pasireotide to treat refractory hypoglycemia due to an insulin-producing pancreatic neuroendocrine tumor |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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:
Key exclusion criteria (29 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PasireotidePasireotide will be used, in addition to diazoxide, as a medical treatment to blunt hypoglycemia in the setting of autonomous insulin secretion. | Drug | Pasireotide |
| DiazoxidePasireotide will be used, in addition to diazoxide, as a medical treatment to blunt hypoglycemia in the setting of autonomous insulin secretion. | Drug | Pasireotide |
Primary outcome
Hypoglycemia
Time frame: up to 12 months
number of times glucose < 70 mg/dl with and without symptoms
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2022.
- Background: PubMed 26732164Tirosh 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kashif M Munir, MD principal investigator
University of Maryland, Baltimore
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pasireotide and Diazoxide in people with Gastro-enteropancreatic Neuroendocrine Tumor, run by University of Maryland, Baltimore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 4 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hypoglycemia (time frame: up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02779257, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2022.