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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00446082
First received: March 9, 2007
Last updated: July 28, 2014
Last verified: July 2014
  Purpose

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 Intervention Phase
Carcinoid Tumor
Acromegaly
Drug: Pasireotide
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Determination of the pharmacokinetic profile of single and monthly doses of pasireotide LAR i.m. injection [ Time Frame: Baseline, D7, D35, D63 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, D7, D35, D63 ] [ Designated as safety issue: No ]
    in patients with acromegaly and in patients with carcinoid disease.


Enrollment: 85
Study Start Date: June 2006
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SOM230 LAR Drug: Pasireotide

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00446082

Locations
United States, California
Cedars Sinai Medical Center SC - 4
Los Angeles, California, United States, 90048
Stanford University Medical Center Stanford Cancer Center (3)
Stanford, California, United States, 94304
United States, Florida
H. Lee Moffitt Cancer Center & Research Institute Dept.of H.LeeMoffittCC&RI(1)
Tampa, Florida, United States, 33612
United States, Texas
University of Texas/MD Anderson Cancer Center Gastrointestinal Med. Oncology
Houston, Texas, United States, 77030-4009
Belgium
Novartis Investigative Site
Bruxelles, Belgium, 1200
Novartis Investigative Site
Leuven, Belgium, 3000
Novartis Investigative Site
Liege, Belgium, 4000
Canada, Ontario
Novartis Investigative Site
London, Ontario, Canada, N6A 4L6
Novartis Investigative Site
Toronto, Ontario, Canada, M5G1X5
Canada, Quebec
Novartis Investigative Site
Montreal, Quebec, Canada, H2L 4M1
Germany
Novartis Investigative Site
Berlin, Germany, 12200
Novartis Investigative Site
Berlin, Germany, 10098
Novartis Investigative Site
Essen, Germany, 45122
Novartis Investigative Site
Leipzig, Germany, 04317
Novartis Investigative Site
Muenchen, Germany, 80336
Netherlands
Novartis Investigative Site
Rotterdam, Netherlands, 3015 CE
Norway
Novartis Investigative Site
Oslo, Norway, NO-0379
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Study Chair: Novartis Novartis
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00446082     History of Changes
Other Study ID Numbers: CSOM230C2110, 2005-003348-75
Study First Received: March 9, 2007
Last Updated: July 28, 2014
Health Authority: United States: Food and Drug Administration
Belgium: Federal Agency for Medicines and Health Products, FAMHP
Canada: Health Canada
Germany: Federal Institute for Drugs and Medical Devices
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Norway: Norwegian Medicines Agency

Keywords provided by Novartis:
Refractory/ resistant carcinoid disease
acromegaly
adults
pasireotide LAR
somatostatin analogue
SOM230
pharmacokinetics
Refractory or resistant carcinoid disease and acromegaly

Additional relevant MeSH terms:
Acromegaly
Carcinoid Tumor
Adenocarcinoma
Bone Diseases
Bone Diseases, Endocrine
Brain Diseases
Carcinoma
Central Nervous System Diseases
Endocrine System Diseases
Hyperpituitarism
Hypothalamic Diseases
Musculoskeletal Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Nervous System Diseases
Neuroectodermal Tumors
Neuroendocrine Tumors
Pituitary Diseases

ClinicalTrials.gov processed this record on November 23, 2014