Study of Pasireotide Long Acting Release (LAR) Injection in Patients With Acromegaly and Patients With Carcinoid Disease

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Acromegaly, Carcinoid Tumor

Intervention / Treatment
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* Drug: Pasireotide


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SOM230 LAR<br> | Drug: Pasireotide<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determination of the pharmacokinetic profile of single and monthly doses of pasireotide LAR i.m. injection | in patients with acromegaly and in patients with carcinoid disease | Baseline, D7, D35, D63 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To explore the pharmacodynamic profile of single and monthly doses of pasireotide LAR i.m. injection | in patients with acromegaly and in patients with carcinoid disease. | Baseline, D7, D35, D63 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Refractory/ resistant carcinoid disease, acromegaly, adults, pasireotide LAR, somatostatin analogue, SOM230, pharmacokinetics, Refractory or resistant carcinoid disease and acromegaly