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

Phase 1

Completed

• Conditions: Acromegaly; Carcinoid Tumor
• Interventions: Drug: Pasireotide

• Registration Number: NCT00446082
• Lead Sponsor: Novartis Pharmaceuticals

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

Detailed Description

Not available

Study Timeline

• Study Start: 2006-06
• Study First Submitted: 2007-03-09
• Study First Submitted QC: 2007-03-09
• Study First Posted: 2007-03-12
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Status Verified: 2016-11
• Last Update Submitted: 2020-12-17
• Last Update Posted: 2020-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 85

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SOM230 LAR	Pasireotide	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (5)

Novartis Investigative Site; 🇳🇴 Oslo, Norway

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, United States

University of Texas/MD Anderson Cancer Center Gastrointestinal Med. Oncology; 🇺🇸 Houston, Texas, United States