Study of Pasireotide in Patients With Rare Tumors of Neuroendocrine Origin

Pancreatic Neoplasm Clinical Trial

Official title:

An Open Label, Multicenter, Single Arm Study of Pasireotide LAR in Patients With Rate Tumors of Neuroendocrine Origin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00958841
• Other study ID #: CSOM230D2203
• Secondary ID: 2008-007348-32
• Status: Completed
• Phase: Phase 2
• First received: July 22, 2009
• Last updated: November 18, 2015
• Start date: September 2009
• Est. completion date: June 2015

Study information

• Verified date: November 2015
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationBrazil: Ministry of HealthCanada: Health CanadaDenmark: Danish Medicines AgencyFinland: Finnish Medicines AgencyFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: BfArMIsrael: Ministry of HealthItaly: The Italian Medicines AgencyNorway: Norwegian Medicines AgencyPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsSpain: Spanish Agency of MedicinesSweden: Medical Products AgencyUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cushing Syndrome
• Ectopic ACTH Syndrome
• Nelson Syndrome
• Neoplasms
• Pancreatic Neoplasm
• Pancreatic Neoplasms
• Pituitary Neoplasm
• Pituitary Neoplasms
• Syndrome

Intervention

Drug:
• Pasireotide LAR
60 mg

Locations

Country	Name	City	State
Argentina	Novartis Investigative Site	Buenos Aires
Australia	Novartis Investigative Site	Fitzroy	Victoria
Australia	Novartis Investigative Site	Westmead	New South Wales
Brazil	Novartis Investigative Site	Belo Horizonte	MG
Brazil	Novartis Investigative Site	Botucatu	SP
Brazil	Novartis Investigative Site	Fortaleza	CE
Canada	Novartis Investigative Site	Halifax	Nova Scotia
Canada	Novartis Investigative Site	Montreal	Quebec
France	Novartis Investigative Site	Angers
France	Novartis Investigative Site	Bron Cedex
France	Novartis Investigative Site	Le Kremlin Bicetre
France	Novartis Investigative Site	LILLE Cedex
France	Novartis Investigative Site	Marseille cedex 05
France	Novartis Investigative Site	Pessac Cedex
France	Novartis Investigative Site	Reims
France	Novartis Investigative Site	Strasbourg
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Erlangen
Germany	Novartis Investigative Site	Frankfurt
Germany	Novartis Investigative Site	Muenchen
Germany	Novartis Investigative Site	Ulm
Germany	Novartis Investigative Site	Würzburg
Italy	Novartis Investigative Site	Ancona	AN
Italy	Novartis Investigative Site	Cona	FE
Italy	Novartis Investigative Site	Padova	PD
Italy	Novartis Investigative Site	Pisa	PI
Italy	Novartis Investigative Site	Roma	RM
Mexico	Novartis Investigative Site	México	Distrito Federal
Russian Federation	Novartis Investigative Site	Moscow
Russian Federation	Novartis Investigative Site	Moscow
Russian Federation	Novartis Investigative Site	Saint-Petersburg
Spain	Novartis Investigative Site	Barcelona	Catalunya
Spain	Novartis Investigative Site	Malaga	Andalucia
Thailand	Novartis Investigative Site	Bangkok
Thailand	Novartis Investigative Site	Bangkok
United States	Dana Farber Cancer Institute Deptof DanaFarberCancerInst(5)	Boston	Massachusetts
United States	Cedars Sinai Medical Center Cedars Sinai 4	Los Angeles	California
United States	Cedars Sinai Medical Center The Pituitary Center (3)	Los Angeles	California
United States	Mount Sinai School of Medicine Study Coordinator	New York	New York
United States	Swedish Medical Center Dept.ofSwedishMedicalCtr.(2)	Seattle	Washington
United States	Stanford University Medical Center SC	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Brazil,  Canada,  France,  Germany,  Italy,  Mexico,  Russian Federation,  Spain,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in disease specific primary biochemical tumor markers		6 months	No
Secondary	Change in disease related symptoms		6 months	No
Secondary	Safety assessments will include vital signs, laboratory values including ECGs, urinalyses and blood biochemistries, and adverse events		monthly between baseline & month 6	Yes