Clinical trial · Interventional
Study of Pasireotide Long Acting Release (LAR) Injection in Patients With Acromegaly and Patients With Carcinoid Disease
A Phase I, Multicenter, Open-label, Randomized Study Assessing the Pharmacokinetics, Safety, and Tolerability of Monthly Doses of Pasireotide i.m. LAR Injection in Patients With Acromegaly and Patients With Carcinoid Disease
NCT00446082CI-TRIAL-00049066completedPhase 1ClinicalTrials.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)
This study will assess the pharmacokinetic profile and the safety/tolerability profile of single and monthly doses of pasireotide LAR intramuscular (i.m.) injection in patients with acromegaly and patients with carcinoid disease
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acromegaly | — | UNRESOLVED | — |
| Carcinoid Tumor | Neuroendocrine Tumor | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pasireotide | Drug | Pasireotide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SOM230 LAR
- interventionNames
- Drug: Pasireotide
Primary outcomes (1)
- measure
- Determination of the pharmacokinetic profile of single and monthly doses of pasireotide LAR i.m. injection
- timeFrame
- Baseline, D7, D35, D63
- description
- in patients with acromegaly and in patients with carcinoid disease
Secondary outcomes (1)
- measure
- To explore the pharmacodynamic profile of single and monthly doses of pasireotide LAR i.m. injection
- timeFrame
- Baseline, D7, D35, D63
- description
- in patients with acromegaly and in patients with carcinoid disease.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria for patients with acromegaly: * Male or female patients between 18 and 80 years * Patients with acromegaly due to a pituitary adenoma with elevated GH and IGF-1 concentrations Exclusion criteria for patients with acromegaly: * Patients with compression of the optic chiasm causing any visual field defect * Specific criteria apply for patients who have received certain types of therapies such as radiotherapies, surgeries, chemo- or immunotherapies in the months prior to study start * Female patients who are pregnant or lactating Inclusion criteria for patients with carcinoid disease: * Male or female patients aged ≥18 years * Patients with histologically confirmed, metastatic carcinoid tumors of the digestive system * Patients with elevation of chromogranin-A (CgA) and/or serotonin * Patients who are not adequately controlled by somatostatin analogues Exclusion criteria for patients with carcinoid disease: * Specific criteria apply for patients who have received certain types of therapies such as radiotherapies, surgeries, chemo- or immunotherapies in the months prior to study start * Female patients who are pregnant or lactating Other protocol-defined in- and exclusion criteria may apply.
References
Publications (1)
- RESULTPetersenn S, Bollerslev J, Arafat AM, Schopohl J, Serri O, Katznelson L, Lasher J, Hughes G, Hu K, Shen G, Resendiz KH, Giannone V, Beckers A. Pharmacokinetics, pharmacodynamics, and safety of pasireotide LAR in patients with acromegaly: a randomized, multicenter, open-label, phase I study. J Clin Pharmacol. 2014 Nov;54(11):1308-17. doi: 10.1002/jcph.326. Epub 2014 May 24. PMID 24800725