Study of Pasireotide in Patients With Rare Tumors of Neuroendocrine Origin

This study has been terminated.
(Slow recruitment rate into this study with rare tumors of neuroendocrine origin (enrollment issues))
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00958841
First received: July 22, 2009
Last updated: June 15, 2016
Last verified: June 2016

July 22, 2009
June 15, 2016
September 2009
June 2015   (final data collection date for primary outcome measure)
Percentage of Responders at Month 6 - Pooled Pancreatic NETs (PNETs) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
The primary efficacy endpoint was defined as the percentage of responders at Month 6 among pooled PNET patients (insulinoma, gastrinoma, VIPoma, and glucagonoma). A responder was defined as a patient who either attained normalization or had a greater than 50% reduction from baseline of the level of the primary biochemical tumor marker at Month 6 (M6). Four insulinoma pts were excluded from analysis because of unavailability of normal ranges for the associated primary biochemical tumor marker (insulin-to-glucose ratio). One patient with VIPoma with a normal baseline was also excluded. As a result, only 20 out of 25 patients with PNET were included in the assessment of the primary endpoint, which was less than the planned sample size of 34. Therefore, the primary objective could not be assessed with sufficient power. Patients with missing Month 6 assessment were considered as non-responders. Responder analyses are reported only for indications with minimum of 6 patients.
Change in disease specific primary biochemical tumor markers [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00958841 on ClinicalTrials.gov Archive Site
  • Percentage of Responders at Month 6 - Individual NETs [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Percentage of responders for each of the 10 NET indications considered in the study. Responder analyses were performed for an indication only if there were at least 6 patients in the efficacy analyzable set. For all other individual indications, the numbers of patients in the efficacy analyzable sets were less than 6 and therefore no responder analyses were carried out for these indications.
  • Percentage of Responders With Probability of Success at Month 6 - Individual NETs [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Percentage of responders for each of the 10 NET indications considered in the study. Responder analyses were performed for an indication only if there were at least 6 patients in the efficacy analyzable set. For all other individual indications, the numbers of patients in the efficacy analyzable sets were less than 6 and therefore no responder analyses were carried out for these indications. The probability of success was a chance that the true responder rate was greater than 15%) for the indications gastrinoma, prolactinoma, and Nelson's syndrome.
  • PNETs: Number of Patients Attaining Normalization or a More Than 50% Reduction in Primary Biochemical Tumor Marker [ Time Frame: Baseline, month 6 ] [ Designated as safety issue: No ]
    Specific primary biochemical tumor markers were used to assess the efficacy of pasireotide in PNETs. A Month 6 responder was defined as the patients who either attained normalization or greater than 50% reduction from baseline in the level of the primary biochemical tumor marker at Month 6. One gastrinoma patient had a missing primary tumor marker value at Month 6, but had a Month 5 assessment done on Day 141, which fell within the allowed window period for Month 6.
  • PiNETs: Number of Patients Attaining Normalization or a More Than 50% Reduction in Primary Biochemical Tumor Marker [ Time Frame: Baseline, month 6 ] [ Designated as safety issue: No ]
    Specific primary biochemical tumor markers were used to assess the efficacy of pasireotide in PNETs. A Month 6 responder was defined as the patients who either attained normalization or greater than 50% reduction from baseline in the level of the primary biochemical tumor marker at Month 6.
  • Nelson's Syndrome: Number of Patients Attaining Normalization or a More Than 50% Reduction in Primary Biochemical Tumor Marker [ Time Frame: Baseline, month 6 ] [ Designated as safety issue: No ]
    Six patients with Nelson's syndrome met the responder's criteria of attaining normalization or a reduction of more than 50% in primary tumor marker at Month 6.
  • 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 Rare 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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Pancreatic Neoplasm
  • Pituitary Neoplasm
  • Nelson Syndrome
  • Ectopic ACTH Syndrome
Drug: pasireotide LAR
Investigational drug pasireotide LAR was supplied in vials with 20 mg or 40 mg powder and 2 mL vehicle was supplied in ampoules for reconstitution.
Other Name: SOM230
Experimental: pasireotide LAR 60mg
Patients received pasireotide LAR at 60 mg approximately once every 28 days for 6 months during the core treatment period and additional treatment cycles up to a total of 48 months during the extension phase.
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.
 
Terminated
118
June 2015
June 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   (Adult, Senior)
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
Colombia,   South Africa
 
NCT00958841
CSOM230D2203, 2008-007348-32
No
Not Provided
Not Provided
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
June 2016

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