Clinical trial NCT00446082: Study of Pasireotide Long Acting Release (LAR) Injection in Patients With Acromegaly and Patients With Carcinoid Disease
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Carcinoid Tumor
Acromegaly
Keywords: Refractory/ resistant carcinoid disease
acromegaly
adults
pasireotide LAR
somatostatin analogue
SOM230
pharmacokinetics
Refractory or resistant carcinoid disease and acromegaly
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2007-03-12
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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


Eligibility criteria: 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.

Primary outcomes:
measure: Determination of the pharmacokinetic profile of single and monthly doses of pasireotide LAR i.m. injection
timeFrame: Baseline, D7, D35, D63
Secondary outcomes:
measure: To explore the pharmacodynamic profile of single and monthly doses of pasireotide LAR i.m. injection
timeFrame: Baseline, D7, D35, D63
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars Sinai Medical Center SC - 4
state: California
city: Stanford
country: United States
facility: Stanford University Medical Center Stanford Cancer Center (3)
state: California
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center & Research Institute Dept.of H.LeeMoffittCC&RI(1)
state: Florida
city: Houston
country: United States
facility: University of Texas/MD Anderson Cancer Center Gastrointestinal Med. Oncology
state: Texas
city: Bruxelles
country: Belgium
facility: Novartis Investigative Site
city: Leuven
country: Belgium
facility: Novartis Investigative Site
city: Liege
country: Belgium
facility: Novartis Investigative Site
city: London
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Toronto
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Montreal
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Essen
country: Germany
facility: Novartis Investigative Site
city: Leipzig
country: Germany
facility: Novartis Investigative Site
city: Muenchen
country: Germany
facility: Novartis Investigative Site
city: Rotterdam
country: Netherlands
facility: Novartis Investigative Site
city: Oslo
country: Norway
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
affiliation: Novartis
name: Novartis
role: STUDY_CHAIR
References:
citation: Petersenn 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.