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Study of Pasireotide in Patients With Rare Tumors of Neuroendocrine Origin

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00958841
First received: July 22, 2009
Last updated: May 15, 2013
Last verified: May 2013
History of Changes
  Purpose

This study will assess the effectiveness and safety of pasireotide long-acting release in patients who have rare tumors of neuroendocrine origin.


Condition Intervention Phase
Pancreatic Neoplasm
Pituitary Neoplasm
Nelson Syndrome
Ectopic ACTH Syndrome
 Drug: Pasireotide LAR
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label, Multicenter, Single Arm Study of Pasireotide LAR in Patients With Rate Tumors of Neuroendocrine Origin

Resource links provided by NLM:

Drug Information available for: Pasireotide
U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Change in disease specific primary biochemical tumor markers [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in disease related symptoms [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Safety assessments will include vital signs, laboratory values including ECGs, urinalyses and blood biochemistries, and adverse events [ Time Frame: monthly between baseline & month 6 ] [ Designated as safety issue: Yes ]

Enrollment: 118
Study Start Date: September 2009
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pasireotide LAR Drug: Pasireotide LAR
60 mg

  Eligibility

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

Inclusion Criteria:

  • Male and Female Patients at least 18 years old

  • Patient who have rare tumors of neuroendocrine origin, such as tumors of the:

    1. pancreas
    2. pituitary glands
    3. Nelson syndrome
    4. ectopic-ACTH secreting tumor
  • Patients who have failed standard of care treatment or for whom no standard of care treatment exist
  • Signed Informed Consent

Exclusion Criteria:

  • Patients with active gallbladder disease
  • Patients with any ongoing or planned anti-neoplastic or interferon therapy
  • Poorly controlled diabetes mellitus
  • Female patients who are pregnant or lactating, or are of childbearing potential and not practicing a medically acceptable method of birth control

Other protocol-defined inclusion/exclusion criteria may apply.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00958841

  Hide Study Locations
Locations
United States, California
Cedars Sinai Medical Center The Pituitary Center (3)
Los Angeles, California, United States, 90048
Cedars Sinai Medical Center Cedars Sinai 4
Los Angeles, California, United States, 90048
Stanford University Medical Center SC
Stanford, California, United States, 94304
United States, Massachusetts
Dana Farber Cancer Institute Deptof DanaFarberCancerInst(5)
Boston, Massachusetts, United States, 02115
United States, New York
Mount Sinai School of Medicine Study Coordinator
New York, New York, United States, 10029
United States, Washington
Swedish Medical Center Dept.ofSwedishMedicalCtr.(2)
Seattle, Washington, United States
Argentina
Novartis Investigative Site
Buenos Aires, Argentina, C1264AAA
Australia, New South Wales
Novartis Investigative Site
Westmead, New South Wales, Australia, 2145
Australia, Victoria
Novartis Investigative Site
Fitzroy, Victoria, Australia, 3065
Brazil
Novartis Investigative Site
Fortaleza, CE, Brazil, 60430-370
Novartis Investigative Site
Belo Horizonte, MG, Brazil, 30130-100
Novartis Investigative Site
Botucatu, SP, Brazil, 18618-970
Canada, Nova Scotia
Novartis Investigative Site
Halifax, Nova Scotia, Canada, B3H 2Y6
Canada, Quebec
Novartis Investigative Site
Montreal, Quebec, Canada, H2L 2W5
France
Novartis Investigative Site
Angers, France, 49033
Novartis Investigative Site
Bron Cedex, France, 69677
Novartis Investigative Site
Le Kremlin Bicetre, France, 94275
Novartis Investigative Site
LILLE Cedex, France, 59037
Novartis Investigative Site
Marseille cedex 05, France, 13385
Novartis Investigative Site
Pessac Cedex, France, 33604
Novartis Investigative Site
Reims, France, 51092
Novartis Investigative Site
Strasbourg, France, 67098
Germany
Novartis Investigative Site
Berlin, Germany, 13353
Novartis Investigative Site
Berlin, Germany, 10098
Novartis Investigative Site
Erlangen, Germany, 91054
Novartis Investigative Site
Frankfurt, Germany, 60590
Novartis Investigative Site
Muenchen, Germany, 80804
Novartis Investigative Site
Ulm, Germany, 89081
Novartis Investigative Site
Weiden, Germany, 92637
Novartis Investigative Site
Würzburg, Germany, 97080
Italy
Novartis Investigative Site
Ancona, AN, Italy, 60126
Novartis Investigative Site
Cona, FE, Italy, 44100
Novartis Investigative Site
Padova, PD, Italy, 35128
Novartis Investigative Site
Roma, RM, Italy, 00168
Novartis Investigative Site
Pisa, Italy, 56124
Mexico
Novartis Investigative Site
México, Distrito Federal, Mexico, 14269
Russian Federation
Novartis Investigative Site
Moscow, Russian Federation, 115478
Novartis Investigative Site
Moscow, Russian Federation, 117036
Novartis Investigative Site
Saint-Petersburg, Russian Federation, 197341
Spain
Novartis Investigative Site
Malaga, Andalucia, Spain, 29010
Novartis Investigative Site
Barcelona, Catalunya, Spain, 08036
Thailand
Novartis Investigative Site
Bangkok, Thailand, 10700
Novartis Investigative Site
Bangkok, Thailand, 10330
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00958841     History of Changes
Other Study ID Numbers: CSOM230D2203, 2008-007348-32
Study First Received: July 22, 2009
Last Updated: May 15, 2013
Health Authority: United States: Food and Drug Administration
Brazil: Ministry of Health
Canada: Health Canada
Denmark: Danish Medicines Agency
Finland: Finnish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: BfArM
Israel: Ministry of Health
Italy: The Italian Medicines Agency
Norway: Norwegian Medicines Agency
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Spain: Spanish Agency of Medicines
Sweden: Medical Products Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Novartis:
Rare tumors of neuroendocrine origin
NETs of the pancreatic
Pituitary NETs
EAS Tumors
Nelson's Syndrome

Additional relevant MeSH terms:
ACTH Syndrome, Ectopic
Cushing Syndrome
Neoplasms
Nelson Syndrome
Pancreatic Neoplasms
Pituitary Neoplasms
Cardiac Complexes, Premature
Paraneoplastic Endocrine Syndromes
Paraneoplastic Syndromes
Adrenocortical Hyperfunction
Adrenal Gland Diseases
Endocrine System Diseases
ACTH-Secreting Pituitary Adenoma
Endocrine Gland Neoplasms
Neoplasms by Site
 Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Digestive System Neoplasms
Digestive System Diseases
Pancreatic Diseases
Hypothalamic Neoplasms
Supratentorial Neoplasms
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Arrhythmias, Cardiac
Heart Diseases

ClinicalTrials.gov processed this record on May 21, 2013