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 27, 2014
Last verified: May 2014
  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:


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: April 2015
Estimated Primary Completion Date: April 2015 (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
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: NCT00958841

  Show 42 Study Locations
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 27, 2014
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 August 19, 2014