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Study Evaluating SOM230 in Patients With Metastatic Carcinoid Tumors
Plain-language guide to NCT00088595: phase 2 non-randomized trial of Pasireotide, 45 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00088595
- Phase
- phase 2
- Status
- completed
- Start
- 2004-01
- Completion (planned or actual)
- 2008-07
- Participants
- 45 (actual)
- Design
- non-randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Carcinoid Tumors
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
This registered phase 2 trial tested Pasireotide.
Study evaluating SOM230 in patients with metastatic carcinoid tumors.
It had 1 arm (groups): Pasireotide (experimental).
The registry classes the interventions as drug.
Who Took Part
Enrollment: 45 actual participants took part.
It was open to people of any sex aged from 18 years up to 80 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Patients with biopsy-proven metastatic carcinoid tumors. Patients with at least one measurable lesion (excluding bone).
The full record lists 3 inclusion and 13 exclusion criteria; among the exclusions: patients who have been previously treated with certain medications may be required to be without certain medications prior to entering the study; patients who have undergone major recent surgery / surgical therapy for any cause within 1 month; patients on any cytotoxic chemotherapy or interferon therapy within the last 2 months.
How the Study Was Run
It was run as a non-randomized, single-group and open-label study.
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 2004-01 with completion listed for 2008-07.
It ran at 4 sites in United States (4).
Its stated primary purpose is treatment.
What Was Measured
Researchers chose this as the main measure: Symptom Control (Diarrhea/Flushing) Using a Patient Symptom Diary (time frame: 15 days).
It also tracked 4 secondary outcomes, for example The Number of Patients (Participants) With Overall Tumor Response and The Overall Safety and Tolerability of Pasireotide.
What This Means in Plain Language
Put simply, this is a phase 2, non-randomized trial of Pasireotide in 45 people.
The trial is marked completed; 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.