Clinical trial · Interventional
Study of Pasireotide in Patients With Rare Tumors of Neuroendocrine Origin
An Open Label, Multicenter, Single Arm Study of Pasireotide LAR in Patients With Rare Tumors of Neuroendocrine Origin
NCT00958841CI-TRIAL-00023240terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Slow recruitment rate into this study with rare tumors of neuroendocrine origin (enrollment issues)
Summary
Brief summary (as posted)
This study will assess the effectiveness and safety of pasireotide long-acting release in patients who have rare tumors of neuroendocrine origin.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ectopic ACTH Syndrome | — | UNRESOLVED | — |
| Nelson Syndrome | — | UNRESOLVED | — |
| Pancreatic Neoplasm | Pancreatic Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Pituitary Neoplasm | Pituitary Gland Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| pasireotide LAR | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- pasireotide LAR 60mg
- description
- Patients received pasireotide LAR at 60 mg approximately once every 28 days for 6 months during the core treatment period and additional treatment cycles up to a total of 48 months during the extension phase.
- interventionNames
- Drug: pasireotide LAR
Primary outcomes (1)
- measure
- Percentage of Responders at Month 6 - Pooled Pancreatic NETs (PNETs)
- timeFrame
- 6 months
- description
- The primary efficacy endpoint was defined as the percentage of responders at Month 6 among pooled PNET patients (insulinoma, gastrinoma, VIPoma, and glucagonoma). A responder was defined as a patient who either attained normalization or had a greater than 50% reduction from baseline of the level of the primary biochemical tumor marker at Month 6 (M6). Four insulinoma pts were excluded from analysis because of unavailability of normal ranges for the associated primary biochemical tumor marker (insulin-to-glucose ratio). One patient with VIPoma with a normal baseline was also excluded. As a result, only 20 out of 25 patients with PNET were included in the assessment of the primary endpoint, which was less than the planned sample size of 34. Therefore, the primary objective could not be assessed with sufficient power. Patients with missing Month 6 assessment were considered as non-responders. Responder analyses are reported only for indications with minimum of 6 patients.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Male and Female Patients at least 18 years old * Patient who have rare tumors of neuroendocrine origin, such as tumors of the: 1. pancreas 2. pituitary glands 3. Nelson syndrome 4. ectopic-ACTH secreting tumor * Patients who have failed standard of care treatment or for whom no standard of care treatment exist * Signed Informed Consent Exclusion Criteria: * Patients with active gallbladder disease * Patients with any ongoing or planned anti-neoplastic or interferon therapy * Poorly controlled diabetes mellitus * Female patients who are pregnant or lactating, or are of childbearing potential and not practicing a medically acceptable method of birth control Other protocol-defined inclusion/exclusion criteria may apply.
References
Publications (0)
Data not yet available
No reference posted for this study.