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Pasireotide Treatment for Neuroendocrine Tumor
Plain-language guide to NCT02779257: phase 4 interventional trial of Pasireotide. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT02779257
- Phase
- phase 4
- Status
- withdrawn
- Start
- 2016-04
- Completion (planned or actual)
- 2016-06
- Participants
- n/a (actual)
- Design
- na, open label (everyone knows who gets what), treatment
- Conditions studied
- Gastro-enteropancreatic Neuroendocrine Tumor
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
In this phase 4 trial, researchers set out to test Pasireotide.
The investigators would like to administer pasireotide as a treatment for refractory hypoglycemia in the setting of metastatic insulin-producing pancreatic neuro-endocrine tumor.
It had 1 arm (groups): Pasireotide (experimental).
Off label use of pasireotide to treat refractory hypoglycemia due to an insulin-producing pancreatic neuroendocrine tumor.
The registry classes the interventions as drug.
Who Took Part
It was open to men only aged from 18 years up to 75 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could 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. Serum bilirubin ≤1.5 x ULN.
The full record lists 16 inclusion and 29 exclusion criteria; among the exclusions: patients with a known hypersensitivity to somatostatin analogs or any component of the pasireotide lar or s.c. formulations; patients currently using warfarin / warfarin derivatives; patients with symptomatic cholelithiasis.
How the Study Was Run
Design: single-group and open-label.
Nothing was hidden in this open-label Pasireotide study: the participants and staff both knew the treatment.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2016-04 with completion listed for 2016-06.
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: Hypoglycemia (time frame: up to 12 months).
What This Means in Plain Language
Put simply, this is a phase 4 trial of Pasireotide in people.
It was withdrawn before enrolling anyone; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Pasireotide compound page, all human trials.
Our Notes on the Compound
Pasireotide: An FDA-approved multi-receptor somatostatin analog for Cushing's disease and acromegaly; high blood sugar is a common side effect.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.