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NCT00446082 Clinical Trial

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

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00446082
Other study ID # CSOM230C2110
Secondary ID 2005-003348-75
Status Completed
Phase Phase 1
First received
Last updated
Start date June 2006
Est. completion date November 2013

Study information
Verified date November 2016
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Pasireotide

Locations
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

Sponsors (1)
Lead Sponsor Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  Germany,  Netherlands,  Norway, 

References & Publications (1)

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

Outcome
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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Completed NCT00500227 - Predictive Factors of Response to Somatostatin Analogues in Acromegalic Patients With Persistent Disease Following Surgery
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Active, not recruiting NCT01809808 - A Prospective Study of Outcome After Therapy for Acromegaly
Completed NCT00145405 - Comparable Effects of Lanreotide Autogel and Octreotide LAR on GH, IGF-I Levels and Patient Satisfaction Phase 4
Completed NCT00210457 - Efficacy and Safety of Lanreotide Autogel (60, 90 or 120 mg) in Acromegalic Patients Phase 3
Recruiting NCT05401084 - Diet in the Management of Acromegaly N/A
Recruiting NCT00005100 - Measurement of Outcome of Surgical Treatment in Patients With Acromegaly N/A
Completed NCT00521300 - Preoperative Octreotide Treatment of Acromegaly Phase 4
Completed NCT03548415 - Safety, Tolerability, and Efficacy of IONIS-GHR-LRx in Participants With Acromegaly Being Treated With Long-acting Somatostatin Receptor Ligands Phase 2
Not yet recruiting NCT04066569 - Reproducibility and Utility of OGTT in Acromegaly N/A
Not yet recruiting NCT05298891 - Hypoproteic Diet in Acromegaly N/A
Recruiting NCT04520646 - A Pilot Study of Empagliflozin in the Treatment of Acromegalic Cardiomyopathy N/A
Not yet recruiting NCT04529356 - The TMS Treatment for Postoperative Headache in GH Tumor N/A
Active, not recruiting NCT03252353 - Efficacy and Safety of Octreotide Capsules (MYCAPSSA) in Acromegaly Phase 3

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