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

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT00446082

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Carcinoid Tumor Acromegaly	Drug: Pasireotide	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

85 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Jun 1, 2006

Actual Primary Completion Date :

Nov 1, 2013

Actual Study Completion Date :

Nov 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SOM230 LAR	Drug: Pasireotide

Arm

Intervention/Treatment

Experimental: SOM230 LAR

Drug: Pasireotide

Outcome Measures

Primary Outcome Measures

Determination of the pharmacokinetic profile of single and monthly doses of pasireotide LAR i.m. injection [Baseline, D7, D35, D63]
in patients with acromegaly and in patients with carcinoid disease

Secondary Outcome Measures

To explore the pharmacodynamic profile of single and monthly doses of pasireotide LAR i.m. injection [Baseline, D7, D35, D63]
in patients with acromegaly and in patients with carcinoid disease.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cedars Sinai Medical Center SC - 4	Los Angeles	California	United States	90048
2	Stanford University Medical Center Stanford Cancer Center (3)	Stanford	California	United States	94304
3	H. Lee Moffitt Cancer Center & Research Institute Dept.of H.LeeMoffittCC&RI(1)	Tampa	Florida	United States	33612
4	University of Texas/MD Anderson Cancer Center Gastrointestinal Med. Oncology	Houston	Texas	United States	77030-4009
5	Novartis Investigative Site	Bruxelles		Belgium	1200
6	Novartis Investigative Site	Leuven		Belgium	3000
7	Novartis Investigative Site	Liege		Belgium	4000
8	Novartis Investigative Site	London	Ontario	Canada	N6A 4L6
9	Novartis Investigative Site	Toronto	Ontario	Canada	M5G1X5
10	Novartis Investigative Site	Montreal	Quebec	Canada	H2L 4M1
11	Novartis Investigative Site	Berlin		Germany	10098
12	Novartis Investigative Site	Berlin		Germany	12203
13	Novartis Investigative Site	Essen		Germany	45122
14	Novartis Investigative Site	Leipzig		Germany	04317
15	Novartis Investigative Site	Muenchen		Germany	80336
16	Novartis Investigative Site	Rotterdam		Netherlands	3015 CE
17	Novartis Investigative Site	Oslo		Norway	NO-0379