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: October 17, 2014
Last verified: October 2014

July 22, 2009
October 17, 2014
September 2009
April 2015   (final data collection date for primary outcome measure)
Change in disease specific primary biochemical tumor markers [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00958841 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Change in disease related symptoms [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Change in disease related symptoms [ Time Frame: assessed monthly, analyzed between baseline & month 6 ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Study of Pasireotide in Patients With Rare Tumors of Neuroendocrine Origin
An Open Label, Multicenter, Single Arm Study of Pasireotide LAR in Patients With Rate Tumors of Neuroendocrine Origin

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

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Pancreatic Neoplasm
  • Pituitary Neoplasm
  • Nelson Syndrome
  • Ectopic ACTH Syndrome
Drug: Pasireotide LAR
60 mg
Experimental: Pasireotide LAR
Intervention: Drug: Pasireotide LAR
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
118
April 2015
April 2015   (final data collection date for primary outcome measure)

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.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Australia,   Brazil,   Canada,   France,   Germany,   Italy,   Mexico,   Russian Federation,   Spain,   Thailand
 
NCT00958841
CSOM230D2203, 2008-007348-32
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP