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Dose Escalation Study of Pasireotide (SOM230) in Patients With Advanced Neuroendocrine Tumors (NETs)
Plain-language guide to NCT01364415: phase 1 interventional trial of Pasireotide, 29 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01364415
- Phase
- phase 1
- Status
- completed
- Start
- 2011-08
- Completion (planned or actual)
- 2016-04
- Participants
- 29 (actual)
- Design
- na, open label (everyone knows who gets what), treatment
- Conditions studied
- Neuroendocrine Tumors
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered phase 1 trial tested Pasireotide.
It had 1 arm (groups): Pasireotide LAR (experimental).
The registry classes the interventions as drug.
Who Took Part
Enrollment: 29 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: ≥18 yrs old, histologically confirmed advanced well or moderately differentiated neuroendocrine tumor/carcinoma. Unresectable metastatic NET tumor with measurable disease. Life expectancy ≥ 12 weeks.
The full record lists 3 inclusion and 6 exclusion criteria; among the exclusions: patients with known hypersensitivity to somatostatin analogs; patients with symptomatic cholelithiasis in the past 2 months; patients with history of another known primary malignancy with exception of non-melanoma skin cancer or carcinoma in situ of uterine cervix.
How the Study Was Run
The set-up was 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 2011-08 with completion listed for 2016-04.
It ran at 4 sites in United States (4).
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: Determine the MTD/RP2D of pasireotide LAR when administered i.m. q28 days to patients with advanced NETs (time frame: Sequentiona 56 day cohorts until the MTD is determined).
It also tracked 4 secondary outcomes, for example assess the safety and tolerability of pasireotide LAR.
What This Means in Plain Language
Put simply, this is a phase 1 trial of Pasireotide in 29 people.
Its size is small, so on its own it can only give an early look.
The trial is marked completed; 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.