← Human Trials & Peer-Reviewed Studies
Study of Pasireotide in Patients With Rare Tumors of Neuroendocrine Origin
Plain-language guide to NCT00958841: phase 2 interventional trial of Pasireotide, 118 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00958841
- Phase
- phase 2
- Status
- terminated early
- Start
- 2009-09
- Completion (planned or actual)
- 2015-06
- Participants
- 118 (actual)
- Design
- na, open label (everyone knows who gets what), treatment
- Conditions studied
- Pancreatic Neoplasm; Pituitary Neoplasm; Nelson Syndrome; Ectopic ACTH Syndrome
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
In this phase 2 trial, researchers set out to test Pasireotide.
It had 1 arm (groups): one (experimental).
The registry classes the interventions as drug.
Who Took Part
Enrollment: 118 actual participants took part.
It was open to people of any sex aged from 18 years with no upper age limit.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Male and Female Patients at least 18 years old. Patient who have rare tumors of neuroendocrine origin, such as tumors of the:. Ectopic-ACTH secreting tumor. Patients who have failed standard of care treatment or for whom no standard of care treatment exist. Signed Informed Consent.
The full record lists 8 inclusion and 4 exclusion criteria; among the exclusions: patients with active gallbladder disease; patients with any ongoing or planned anti-neoplastic or interferon therapy; poorly controlled diabetes mellitus.
How the Study Was Run
It was run as a single-group and open-label study.
Being open-label, the Pasireotide study did not mask who received what.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2009-09 with completion listed for 2015-06.
It ran at 42 sites in France (8), Germany (7), United States (6), Italy (5), Brazil (3) and Russia (3).
Its stated primary purpose is treatment.
What Was Measured
Researchers chose this as the main measure: Percentage of Responders at Month 6 - Pooled Pancreatic NETs (PNETs) (time frame: 6 months).
It also tracked 5 secondary outcomes, for example Percentage of Responders at Month 6 - Individual NETs and Percentage of Responders With Probability of Success at Month 6 - Individual NETs.
What This Means in Plain Language
Put simply, this is a phase 2 trial of Pasireotide in 118 people.
It ended early (terminated); results are posted on the registry, and this page does not restate them.
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.