Clinical trial · Interventional
Study Evaluating SOM230 in Patients With Metastatic Carcinoid Tumors
An Open-label, Multicenter, Phase II Study Evaluating the Safety and Efficacy of Twice Daily Dosing of SOM230 in Patients With Metastatic Carcinoid Tumors
NCT00088595CI-TRIAL-00007046completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Study evaluating SOM230 in patients with metastatic carcinoid tumors
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoid Tumors | Neuroendocrine Tumor | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pasireotide (SOM230) | Drug | Pasireotide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Pasireotide
- interventionNames
- Drug: Pasireotide (SOM230)
Primary outcomes (1)
- measure
- Symptom Control (Diarrhea/Flushing) Using a Patient Symptom Diary
- timeFrame
- 15 days
- description
- Complete Symptom Control: an average of ≤ 3 bowel movements per day for at least 15 consecutive days, with no more than 3 episodes on any given day, and no episodes of flushing over the time interval being studied. Partial Symptom Control: an average of \< 4 bowel movements per day for at least 15 consecutive days, with no more than 6 episodes per given day, and an average of fewer than 2 daily flushing episodes over the same given time interval. Treatment failure: Failure to obtain partial or complete treatment success over a consecutive 15-day period at a constant dose level.
Secondary outcomes (4)
- measure
- Duration of Complete Symptom Control (Days) by Dose Class
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with biopsy-proven metastatic carcinoid tumors * Patients with at least one measurable lesion (excluding bone) * Patients must be considered inadequately controlled while on Sandostatin LAR therapy based on the symptoms of carcinoid syndrome (diarrhea and/or flushing) as defined as experiencing a minimum average of at least four bowel movements per day or a minimum average of at least two episodes of flushing per day Exclusion Criteria: * 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 * Patients with uncontrolled diabetes mellitus * Patients who had received radiotherapy for any reason within the last 4 weeks must have recovered from any side effects of radiotherapy * Patients who have congestive heart failure unstable angina, cardiac arrhythmia or a history of acute myocardial infarction within the three months preceding enrollment * Patients with chronic liver disease * Female patients who are pregnant or lactating, or are of childbearing potential and not practicing a medically acceptable method for birth control. * History of immunocompromise, including a positive HIV test result * Patients who have a history of alcohol or drug abuse in the 6 month period prior to receiving SOM230 * Patients who have given a blood donation (of 400 mL or more) within 2 months before receiving SOM230 * Patients who have participated in any clinical investigation with an investigational drug within 1 month prior to dosing * Patients with additional active malignant disease within the last five years
References
Publications (0)
Data not yet available
No reference posted for this study.