WithdrawnPhase 4

Pasireotide Treatment for Neuroendocrine Tumor

Stopped: Subject passed away prior to enrollment

0Started 2016-04

Plain-language 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.

Who can participate

Age range18 Years – 75 Years

SexMALE

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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:
✓. 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)

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:.
✕. Patients who have any severe and/or uncontrolled medical conditions :

What they're measuring

Hypoglycemia

Timeframe: up to 12 months

Trial details

NCT IDNCT02779257

SponsorUniversity of Maryland, Baltimore

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-06

View on ClinicalTrials.gov More Gastro-enteropancreatic Neuroendocrine Tumor trials