Clinical trial NCT00690430: Efficacy and Safety of Pasireotide Long Acting Release vs. Octreotide Long Acting Release in Patients With Metastatic Carcinoid Disease
Official title: A Multicenter, Randomized, Blinded Efficacy and Safety Study of Pasireotide LAR vs Octreotide LAR in Patients With Metastatic Carcinoid Tumors Whose Disease-related Symptoms Are Inadequately Controlled by Somatostatin Analogues.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Symptomatic Refractory Resistant Carcinoid Disease
Keywords: Carcinoid
neuroendocrine
gastroenteropancreatic
somatostatin analogue
Symptomatic Refractory Resistant Carcinoid Disease
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2008-06-04
Enrollment: 186
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this randomized, multicenter, Phase III study was to compare the efficacy of paseriotide LAR and octreotide LAR in patients whose disease-related symptoms are inadequately controlled by currently available somatostatin analogues.


Eligibility criteria: Inclusion criteria:

* Male or female patients aged 18 or greater
* Patients with carcinoid tumors and symptoms (diarrhea and flushing) that are not adequately controlled by somatostatin analogues.
* Female patients of child bearing potential must have a negative pregnancy test at baseline.
* Patients for whom written informed consent to participate in the study has been obtained.

Exclusion criteria:

* Patients receiving radiolabeled somatostatin analogue therapy within the 3 months or any cytotoxic chemotherapy or interferon therapy within the 4 weeks prior to randomization
* Diabetic patients on anti-diabetic medications whose fasting blood glucose is poorly controlled as indicated by HBA1C \> 8%
* Patients with symptomatic cholelithiasis
* Patient with malabsorption syndrome, short bowel or cholegenic diarrhea not controlled by specific therapeutic means.

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Percentage of Patients Who Achieved Clinical Symptom Improvement by Randomization Stratum and Treatment.
timeFrame: Month 6
Secondary outcomes:
measure: Improvement in Daily Mean Number of Diarrhea Bowel Movement Episodes by Randomization Stratum and Treatment.
timeFrame: 6 months
measure: Improvement in Daily Mean Number of Flushing Episodes by Randomization Stratum and Treatment.
timeFrame: 6 months
measure: Pasireotide LAR vs. Octreotide LAR on Time to Symptom Response.
timeFrame: Month 6
measure: Objective Tumor Response Rate Assessed by Investigator
timeFrame: Month 6
measure: Pasireotide LAR vs. Octreotide LAR on Disease Control Rate Based on RECIST Criteria
timeFrame: Month 6
measure: Pasireotide LAR vs. Octreotide LAR on Quality of Life Assessed by FACIT-D Questionnaire
timeFrame: Month 6
measure: Pasireotide LAR vs. Octreotide LAR on Time to Symptom Progression
timeFrame: Month 6
measure: Pasireotide LAR vs. Octreotide LAR on Duration of Symptom Response
timeFrame: Month 6
measure: Assess the Proportion of Patients Who Achieved at Least a 30% Reduction in Frequency of Bowel Movements
timeFrame: Month 6
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Scottsdale Healthcare/TGen Clinical Research Service TGen Clinical Research Service
state: Arizona
city: Tucson
country: United States
facility: University of Arizona / Arizona Cancer Center
state: Arizona
city: Loma Linda
country: United States
facility: Loma Linda University Dept. of Loma Linda CancerCent
state: California
city: Los Angeles
country: United States
facility: Cedars Sinai Medical Center Cedars Sinai 4
state: California
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center/University of South Florida Dept of H. Lee Moffit
state: Florida
city: Bronx
country: United States
facility: Montefiore Medical Center MMC
state: New York
city: New York
country: United States
facility: Mount Sinai School of Medicine Study Coordinator
state: New York
city: Durham
country: United States
facility: Duke University Medical Center Dept. of Duke Cancer Center(2)
state: North Carolina
city: Bethlehem
country: United States
facility: St. Luke's Hospital and Health Network St. Luke's Cancer Network
state: Pennsylvania
city: Houston
country: United States
facility: MD Anderson Cancer Center/University of Texas Dept. of MD Anderson (9)
state: Texas
city: Buenos Aires
country: Argentina
facility: Novartis Investigative Site
city: Buenos Aires
country: Argentina
facility: Novartis Investigative Site
city: Graz
country: Austria
facility: Novartis Investigative Site
city: Salzburg
country: Austria
facility: Novartis Investigative Site
city: Vienna
country: Austria
facility: Novartis Investigative Site
city: Bruxelles
country: Belgium
facility: Novartis Investigative Site
city: Gent
country: Belgium
facility: Novartis Investigative Site
city: Fortaleza
country: Brazil
facility: Novartis Investigative Site
state: CE
city: Calgary
country: Canada
facility: Novartis Investigative Site
state: Alberta
city: Halifax
country: Canada
facility: Novartis Investigative Site
state: Nova Scotia
city: Montreal
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Clichy
country: France
facility: Novartis Investigative Site
city: Dijon
country: France
facility: Novartis Investigative Site
city: Lyon
country: France
facility: Novartis Investigative Site
city: Marseille cedex 05
country: France
facility: Novartis Investigative Site
city: Montpellier cedex 5
country: France
facility: Novartis Investigative Site
city: Nice Cedex
country: France
facility: Novartis Investigative Site
city: Strasbourg
country: France
facility: Novartis Investigative Site
city: Bad Berka
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Heidelberg
country: Germany
facility: Novartis Investigative Site
city: Mainz
country: Germany
facility: Novartis Investigative Site
city: München
country: Germany
facility: Novartis Investigative Site
city: Jerusalem
country: Israel
facility: Novartis Investigative Site
city: Bologna
country: Italy
facility: Novartis Investigative Site
state: BO
city: Milano
country: Italy
facility: Novartis Investigative Site
state: MI
city: Milano
country: Italy
facility: Novartis Investigative Site
state: MI
city: Milano
country: Italy
facility: Novartis Investigative Site
state: MI
city: Modena
country: Italy
facility: Novartis Investigative Site
state: MO
city: Perugia
country: Italy
facility: Novartis Investigative Site
state: PG
city: Roma
country: Italy
facility: Novartis Investigative Site
state: RM
city: Orbassano
country: Italy
facility: Novartis Investigative Site
state: TO
city: Tromsø
country: Norway
facility: Novartis Investigative Site
city: Trondheim
country: Norway
facility: Novartis Investigative Site
city: Gliwice
country: Poland
facility: Novartis Investigative Site
state: Slaskie
city: Gdansk
country: Poland
facility: Novartis Investigative Site
city: Singapore
country: Singapore
facility: Novartis Investigative Site
city: Hospitalet de Llobregat
country: Spain
facility: Novartis Investigative Site
state: Cataluña
city: Santiago de Compostela
country: Spain
facility: Novartis Investigative Site
state: Galicia
city: Jönköping
country: Sweden
facility: Novartis Investigative Site
city: Linköping
country: Sweden
facility: Novartis Investigative Site
city: Lund
country: Sweden
facility: Novartis Investigative Site
city: Stockholm
country: Sweden
facility: Novartis Investigative Site
city: Stockholm
country: Sweden
facility: Novartis Investigative Site
city: Uppsala
country: Sweden
facility: Novartis Investigative Site
city: Withington
country: United Kingdom
facility: Novartis Investigative Site
state: Greater Manchester
city: Sheffield
country: United Kingdom
facility: Novartis Investigative Site
state: South Yorkshire
city: Basingstoke
country: United Kingdom
facility: Novartis Investigative Site
city: Birmingham
country: United Kingdom
facility: Novartis Investigative Site
city: Glasgow
country: United Kingdom
facility: Novartis Investigative Site
city: London
country: United Kingdom
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: