search
Back to results

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

Primary Purpose

Carcinoid Tumor, Acromegaly

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Pasireotide
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoid Tumor focused on measuring Refractory/ resistant carcinoid disease, acromegaly, adults, pasireotide LAR, somatostatin analogue, SOM230, pharmacokinetics, Refractory or resistant carcinoid disease and acromegaly

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Cedars Sinai Medical Center SC - 4
  • Stanford University Medical Center Stanford Cancer Center (3)
  • H. Lee Moffitt Cancer Center & Research Institute Dept.of H.LeeMoffittCC&RI(1)
  • University of Texas/MD Anderson Cancer Center Gastrointestinal Med. Oncology
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SOM230 LAR

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
March 9, 2007
Last Updated
December 17, 2020
Sponsor
Novartis Pharmaceuticals
search

1. Study Identification

Unique Protocol Identification Number
NCT00446082
Brief Title
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

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
November 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoid Tumor, Acromegaly
Keywords
Refractory/ resistant carcinoid disease, acromegaly, adults, pasireotide LAR, somatostatin analogue, SOM230, pharmacokinetics, Refractory or resistant carcinoid disease and acromegaly

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
85 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SOM230 LAR
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Pasireotide
Primary Outcome Measure Information:
Title
Determination of the pharmacokinetic profile of single and monthly doses of pasireotide LAR i.m. injection
Description
in patients with acromegaly and in patients with carcinoid disease
Time Frame
Baseline, D7, D35, D63
Secondary Outcome Measure Information:
Title
To explore the pharmacodynamic profile of single and monthly doses of pasireotide LAR i.m. injection
Description
in patients with acromegaly and in patients with carcinoid disease.
Time Frame
Baseline, D7, D35, D63

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Novartis
Organizational Affiliation
Novartis
Official's Role
Study Chair
Facility Information:
Facility Name
Cedars Sinai Medical Center SC - 4
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Stanford University Medical Center Stanford Cancer Center (3)
City
Stanford
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
H. Lee Moffitt Cancer Center & Research Institute Dept.of H.LeeMoffittCC&RI(1)
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
University of Texas/MD Anderson Cancer Center Gastrointestinal Med. Oncology
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4009
Country
United States
Facility Name
Novartis Investigative Site
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Novartis Investigative Site
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Novartis Investigative Site
City
Liege
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Novartis Investigative Site
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4L6
Country
Canada
Facility Name
Novartis Investigative Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G1X5
Country
Canada
Facility Name
Novartis Investigative Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 4M1
Country
Canada
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
10098
Country
Germany
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
12203
Country
Germany
Facility Name
Novartis Investigative Site
City
Essen
ZIP/Postal Code
45122
Country
Germany
Facility Name
Novartis Investigative Site
City
Leipzig
ZIP/Postal Code
04317
Country
Germany
Facility Name
Novartis Investigative Site
City
Muenchen
ZIP/Postal Code
80336
Country
Germany
Facility Name
Novartis Investigative Site
City
Rotterdam
ZIP/Postal Code
3015 CE
Country
Netherlands
Facility Name
Novartis Investigative Site
City
Oslo
ZIP/Postal Code
NO-0379
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
24800725
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.
Results Reference
result
Links:
URL
https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=12987
Description
Novartis Clinical Trial Results for CSOM230C2110

Learn more about this trial

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

We'll reach out to this number within 24 hrs