Clinical trial NCT00958841: Study of Pasireotide in Patients With Rare Tumors of Neuroendocrine Origin
Official title: An Open Label, Multicenter, Single Arm Study of Pasireotide LAR in Patients With Rare Tumors of Neuroendocrine Origin
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Pancreatic Neoplasm
Pituitary Neoplasm
Nelson Syndrome
Ectopic ACTH Syndrome
Keywords: Rare tumors of neuroendocrine origin
NETs of the pancreatic
Pituitary NETs
EAS Tumors
Nelson's Syndrome
Pancreatic neoplasm
pituitary neoplasm
Nelson Syndrome
ectopic ACTH syndrome
pasireotide LAR
PNETs
PiNETS
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2009-08-13
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility 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.

Primary outcomes:
measure: Percentage of Responders at Month 6 - Pooled Pancreatic NETs (PNETs)
timeFrame: 6 months
Secondary outcomes:
measure: Percentage of Responders at Month 6 - Individual NETs
timeFrame: 6 months
measure: Percentage of Responders With Probability of Success at Month 6 - Individual NETs
timeFrame: 6 months
measure: PNETs: Number of Patients Attaining Normalization or a More Than 50% Reduction in Primary Biochemical Tumor Marker
timeFrame: Baseline, month 6
measure: PiNETs: Number of Patients Attaining Normalization or a More Than 50% Reduction in Primary Biochemical Tumor Marker
timeFrame: Baseline, month 6
measure: Nelson's Syndrome: Number of Patients Attaining Normalization or a More Than 50% Reduction in Primary Biochemical Tumor Marker
timeFrame: Baseline, month 6
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars Sinai Medical Center Cedars Sinai 4
state: California
city: Los Angeles
country: United States
facility: Cedars Sinai Medical Center The Pituitary Center (3)
state: California
city: Stanford
country: United States
facility: Stanford University Medical Center SC
state: California
city: Boston
country: United States
facility: Dana Farber Cancer Institute Deptof DanaFarberCancerInst(5)
state: Massachusetts
city: New York
country: United States
facility: Mount Sinai School of Medicine Study Coordinator
state: New York
city: Seattle
country: United States
facility: Swedish Medical Center Dept.ofSwedishMedicalCtr.(2)
state: Washington
city: Buenos Aires
country: Argentina
facility: Novartis Investigative Site
city: Westmead
country: Australia
facility: Novartis Investigative Site
state: New South Wales
city: Fitzroy
country: Australia
facility: Novartis Investigative Site
state: Victoria
city: Fortaleza
country: Brazil
facility: Novartis Investigative Site
state: CE
city: Belo Horizonte
country: Brazil
facility: Novartis Investigative Site
state: MG
city: Botucatu
country: Brazil
facility: Novartis Investigative Site
state: SP
city: Halifax
country: Canada
facility: Novartis Investigative Site
state: Nova Scotia
city: Montreal
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Angers
country: France
facility: Novartis Investigative Site
city: Bron Cedex
country: France
facility: Novartis Investigative Site
city: Le Kremlin Bicetre
country: France
facility: Novartis Investigative Site
city: Lille Cedex
country: France
facility: Novartis Investigative Site
city: Marseille cedex 05
country: France
facility: Novartis Investigative Site
city: Pessac Cedex
country: France
facility: Novartis Investigative Site
city: Reims
country: France
facility: Novartis Investigative Site
city: Strasbourg
country: France
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Erlangen
country: Germany
facility: Novartis Investigative Site
city: Frankfurt
country: Germany
facility: Novartis Investigative Site
city: Muenchen
country: Germany
facility: Novartis Investigative Site
city: Ulm
country: Germany
facility: Novartis Investigative Site
city: Würzburg
country: Germany
facility: Novartis Investigative Site
city: Ancona
country: Italy
facility: Novartis Investigative Site
state: AN
city: Cona
country: Italy
facility: Novartis Investigative Site
state: FE
city: Padova
country: Italy
facility: Novartis Investigative Site
state: PD
city: Pisa
country: Italy
facility: Novartis Investigative Site
state: PI
city: Roma
country: Italy
facility: Novartis Investigative Site
state: RM
city: México
country: Mexico
facility: Novartis Investigative Site
state: Distrito Federal
city: Moscow
country: Russian Federation
facility: Novartis Investigative Site
city: Moscow
country: Russian Federation
facility: Novartis Investigative Site
city: Saint-Petersburg
country: Russian Federation
facility: Novartis Investigative Site
city: Malaga
country: Spain
facility: Novartis Investigative Site
state: Andalucia
city: Barcelona
country: Spain
facility: Novartis Investigative Site
state: Catalunya
city: Bangkok
country: Thailand
facility: Novartis Investigative Site
city: Bangkok
country: Thailand
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: