An Open-label Multicenter Single Arm Study of Pasireotide LAR in Patients with Rare Tumors of Neuroendocrine Origin.
- Type of Study
- Neuroscience - Brain Tumor /Neuroendocrine
- Short Description
Evaluate the efficacy and safety of pasireotide LAR in patients with rare tumors of neuroendocrine origin who have disease progression despite standard therapy or for whom no standard therapy is available.
- Closed to Enrollment
- Principal Investigator
- Frances E Broyles, MD
- Eligibility Notes
- Male or female at least 18 years of age or older.
- Standard of care treatment either has not worked or is not available.
- Must have one of the following tumor types: insulinoma, gastrinoma, VIPoma, glucagonoma, prolactinoma,thyrotropic-pituitary adenoma, gonadotripic adenoma, non-functioning pituitary adenoma, ectopic ACTH secreting (EAS) tumors, Nelson's syndrome.
- Active gallbladder disease.
- Ongoing or planned anti-neoplastic therapy.
- Ongoing or planned therapy with interferon.
- Poorly controlled diabetes mellitus (HbA1c >8%)
- Patients with radiolabelled somatostatin analog therapy within 6 months of visit 1, cytotoxic theraphy or interferon within 2 months of visit 1, radiotherapy within 1 month of visit 1.
- Cardiac abnormalities: QTcF >450msec at screening, history of syncope, sustained or clinically significant cardiac arrhythmias, risk factors for Torsades de Pointes (hypokalemia, hypomagnesemia, cardiac failure, bradycardia, high-grade AV block), concomitant disease that could prolong QT interval (autonomic neuropathy, HIV, cirrhosis, uncontrolled hypothyroidism, cardiac failure), concomitant medications known to prolong QT interval.
- Patients with abnormal blood coagulation.
- Female patients who are pregnant or nursing.
- Patients who have participated in any clinical study that used an investigational drug within 30 days of first dose.
- Contact Name
- Becky Wood
- Alternate Phone
- Alternate Email