Acromegaly Clinical Trial
Official title:
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
Verified date | November 2016 |
Source | Novartis |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 85 |
Est. completion date | November 2013 |
Est. primary completion date | November 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Belgium | Novartis Investigative Site | Bruxelles | |
Belgium | Novartis Investigative Site | Leuven | |
Belgium | Novartis Investigative Site | Liege | |
Canada | Novartis Investigative Site | London | Ontario |
Canada | Novartis Investigative Site | Montreal | Quebec |
Canada | Novartis Investigative Site | Toronto | Ontario |
Germany | Novartis Investigative Site | Berlin | |
Germany | Novartis Investigative Site | Berlin | |
Germany | Novartis Investigative Site | Essen | |
Germany | Novartis Investigative Site | Leipzig | |
Germany | Novartis Investigative Site | Muenchen | |
Netherlands | Novartis Investigative Site | Rotterdam | |
Norway | Novartis Investigative Site | Oslo | |
United States | University of Texas/MD Anderson Cancer Center Gastrointestinal Med. Oncology | Houston | Texas |
United States | Cedars Sinai Medical Center SC - 4 | Los Angeles | California |
United States | Stanford University Medical Center Stanford Cancer Center (3) | Stanford | California |
United States | H. Lee Moffitt Cancer Center & Research Institute Dept.of H.LeeMoffittCC&RI(1) | Tampa | Florida |
Lead Sponsor | Collaborator |
---|---|
Novartis Pharmaceuticals |
United States, Belgium, Canada, Germany, Netherlands, Norway,
Petersenn S, Bollerslev J, Arafat AM, Schopohl J, Serri O, Katznelson L, Lasher J, Hughes G, Hu K, Shen G, Reséndiz KH, Giannone V, Beckers A. Pharmacokinetics, pharmacodynamics, and safety of pasireotide LAR in patients with acromegaly: a randomized, mul — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 |
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