Safety and Efficacy of Pasireotide Long Acting Release (LAR) vs. Octreotide LAR in Patients With Active Acromegaly

Acromegaly Clinical Trial

Official title:

A Multicenter, Randomized, Blinded Study to Assess Safety and Efficacy of Pasireotide LAR vs. Octreotide LAR in Patients With Active Acromegaly

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00600886
• Other study ID #: CSOM230C2305
• Secondary ID: 2007-001972-36
• Status: Active, not recruiting
• Phase: Phase 3
• First received: January 14, 2008
• Last updated: November 7, 2015
• Start date: February 2008
• Est. completion date: March 2016

Study information

• Verified date: November 2015
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationArgentina: Ministry of HealthAustralia: Department of HealthBelgium: Ministry of Social Affairs, Public Health and the EnvironmentBrazil: National Health Surveillance AgencyCanada: Food Inspection AgencyChina: Ministry of HealthColombia: Institutional Review BoardCzech Republic: Ministry of HealthDenmark: Ministry of HealthFrance: Ministry of HealthGreece: Ministry of Health and WelfareGermany: Ministry of HealthHungary: National Institute of PharmacyIsrael: Ministry of HealthItaly: Ministry of HealthKorea, Republic of: Food and Drug AdministrationMexico: Ministry of HealthNetherlands: Ministry of Health, Welfare and SportsNorway: Norwegian Medicines AgencyPoland: Ministry of Health and Social SecurityPortugal: Ministry of HealthRussia: Ministry of Public healthSpain: Ministry of Health and ConsumptionSweden: Medical Products AgencySwitzerland: EthikkommissionTurkey: Ministry of HealthTaiwan: Department of HealthUnited Kingdom: Health Protection AgencyVenezuela: Ministry of Health and Social Development
• Study type: Interventional

Clinical Trial Summary

The patients will receive either Pasireotide LAR or Octreotide LAR for one year of treatment.

The objective of this study is to compare the proportion of patients with a reduction of mean GH level to <2.5 µg/L and the normalization of IGF-1 to within normal limits (age and sex related) between the two treatment groups (pasireotide LAR and octreotide LAR) at 12 months.

Following one year of treatment patients may proceed into the study extension. Patients who did not respond to the treatment they were randomized to (based on month 12 assessment results) will be switched to the other treatment arm at month 13.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 358
• Est. completion date: March 2016
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• Patients with active acromegaly (based on elevated GH and IGF-1 levels)

• Patients who have undergone one or more pituitary surgeries, but have not been treated medically, or de-novo patients presenting a visible pituitary adenoma on MRI and who refuse pituitary surgery or for whom pituitary surgery is contraindicated

• Patients for whom written informed consent to participate in the study has been obtained prior to any study related activity

Exclusion criteria:

• Patients who are being or were treated with octreotide, lanreotide, dopamine agonists or GH antagonists with the exception of a single dose of short-acting octrotide or short-acting dopamine agonists. In case of a single dose of short-acting octrotide, the dose should not be used to predict the response to the octretide treatment. The single dose of short-acting octreotide or short-acting dopamine agonists should not be administered in the 3 days prior to randomization

• Patients with compression of the optic chiasm causing any visual field defect

• Patients who have received pituitary irradiation within the last ten years prior to visit 1

• Poorly controlled diabetic patients

Other protocol-defined inclusion/exclusion criteria may apply

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acromegaly

Intervention

Drug:
• Pasireotide
SOM230 LAR
• Octreotide
Sandostatin LAR

Locations

Country	Name	City	State
Argentina	Novartis Investigative Site	Buenos Aires
Argentina	Novartis Investigative Site	Buenos Aires
Argentina	Novartis Investigative Site	Capital Federal	Buenos Aires
Belgium	Novartis Investigative Site	Brussel
Belgium	Novartis Investigative Site	Bruxelles
Belgium	Novartis Investigative Site	Gent
Belgium	Novartis Investigative Site	Leuven
Brazil	Novartis Investigative Site	Brasilia	DF
Brazil	Novartis Investigative Site	Curitiba	PR
Brazil	Novartis Investigative Site	Fortaleza	CE
Brazil	Novartis Investigative Site	Rio de Janeiro	RJ
Brazil	Novartis Investigative Site	Sao Luis	MA
Brazil	Novartis Investigative Site	Sao Paulo	SP
Canada	Novartis Investigative Site	Edmonton	Alberta
Canada	Novartis Investigative Site	Halifax	Nova Scotia
Canada	Novartis Investigative Site	Montreal	Quebec
Canada	Novartis Investigative Site	Sherbrooke	Quebec
Canada	Novartis Investigative Site	Vancouver	British Columbia
China	Novartis Investigative Site	Beijing	Beijing
China	Novartis Investigative Site	Shanghai
Colombia	Novartis Investigative Site	Bogota	Cundinamarca
Czech Republic	Novartis Investigative Site	Prague 2
Denmark	Novartis Investigative Site	Aalborg
Denmark	Novartis Investigative Site	Copenhagen
France	Novartis Investigative Site	Bois Guillaume Cedex
France	Novartis Investigative Site	Bron Cedex
France	Novartis Investigative Site	Le Kremlin Bicetre
France	Novartis Investigative Site	Marseille cedex 05
France	Novartis Investigative Site	Montpellier Cedex 5
France	Novartis Investigative Site	Paris
France	Novartis Investigative Site	Pessac Cedex
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Erlangen
Germany	Novartis Investigative Site	Essen
Germany	Novartis Investigative Site	Muenchen
Greece	Novartis Investigative Site	Athens	GR
Hungary	Novartis Investigative Site	Budapest
Israel	Novartis Investigative Site	Jerusalem
Israel	Novartis Investigative Site	Petach Tikva
Italy	Novartis Investigative Site	Cona	FE
Italy	Novartis Investigative Site	Genova	GE
Italy	Novartis Investigative Site	Napoli
Italy	Novartis Investigative Site	Padova	PD
Italy	Novartis Investigative Site	Pisa	PI
Italy	Novartis Investigative Site	Roma	RM
Italy	Novartis Investigative Site	Torino	TO
Korea, Republic of	Novartis Investigative Site	Seoul	Korea
Korea, Republic of	Novartis Investigative Site	Seoul	Korea
Korea, Republic of	Novartis Investigative Site	Seoul	Korea
Korea, Republic of	Novartis Investigative Site	Seoul
Mexico	Novartis Investigative Site	Mexico	Distrito Federal
Mexico	Novartis Investigative Site	México	Distrito Federal
Netherlands	Novartis Investigative Site	Nijmegen
Netherlands	Novartis Investigative Site	Rotterdam
Norway	Novartis Investigative Site	Bergen
Norway	Novartis Investigative Site	Oslo
Poland	Novartis Investigative Site	Kraków
Poland	Novartis Investigative Site	Warszawa
Russian Federation	Novartis Investigative Site	Moscow
Russian Federation	Novartis Investigative Site	Moscow
Russian Federation	Novartis Investigative Site	Saint-Petersburg
Russian Federation	Novartis Investigative Site	Saint-Petersburg
Spain	Novartis Investigative Site	Alicante	Comunidad Valenciana
Spain	Novartis Investigative Site	Hospitalet de Llobregat	Barcelona
Spain	Novartis Investigative Site	Santiago de Compostela	Galicia
Spain	Novartis Investigative Site	Sevilla	Andalucia
Sweden	Novartis Investigative Site	Linkoping
Sweden	Novartis Investigative Site	Malmö
Sweden	Novartis Investigative Site	Uppsala
Switzerland	Novartis Investigative Site	St. Gallen
Taiwan	Novartis Investigative Site	Lin-Kou
Taiwan	Novartis Investigative Site	Taichung
Taiwan	Novartis Investigative Site	Taipei
Turkey	Novartis Investigative Site	Ankara
Turkey	Novartis Investigative Site	Erzurum
United Kingdom	Novartis Investigative Site	Leeds
United Kingdom	Novartis Investigative Site	Liverpool
United Kingdom	Novartis Investigative Site	London
United Kingdom	Novartis Investigative Site	Southampton
United States	University of Michigan Comprehensive Cancer Center Deptof Endocrinology&Diabetes	Ann Arbor	Michigan
United States	Johns Hopkins University School of Medicine Dept.ofJohnsHopkinsUniv.	Baltimore	Maryland
United States	University of Texas Southwestern Medical Center Danziger Research Bldg.	Dallas	Texas
United States	University of Florida SC	Gainesville	Florida
United States	Baylor College of Medicine	Houston	Texas
United States	University of Texas/MD Anderson Cancer Center Regulatory -12	Houston	Texas
United States	Cedars Sinai Medical Center The Pituitary Center	Los Angeles	California
United States	University of California at Los Angeles Division of Endocrinology	Los Angeles	California
United States	Columbia University Medical Center- New York Presbyterian Dept. of CU Collegeof Phys&Sur	New York	New York
United States	Northport VA Medical Center CSOM230C2305	Northport	New York
United States	Allegheny Endocrinology Associates	Pittsburgh	Pennsylvania
United States	Oregon Health & Sciences University DeptofOregonHealth&Sciences(3)	Portland	Oregon
United States	Swedish Medical Center Dept.ofSeattle Neuroscience(2)	Seattle	Washington
United States	Stanford University Medical Center Stanford Cancer Center (3)	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Argentina,  Belgium,  Brazil,  Canada,  China,  Colombia,  Czech Republic,  Denmark,  France,  Germany,  Greece,  Hungary,  Israel,  Italy,  Korea, Republic of,  Mexico,  Netherlands,  Norway,  Poland,  Russian Federation,  Spain,  Sweden,  Switzerland,  Taiwan,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compare the Proportion of Patients With a Reduction of Mean GH Level to <2.5 ug/L and the Normalization of IGF-1 Between the Two Teatments Groups	"Post Surgery" were participants who underwent surgery and their data were collected post surgery. Remaining participant, who were not suitable for or refused surgery, were considered "De novo".	12 months	No
Secondary	Effect of Pasireotide LAR vs. Octreotide LAR on Reduction of GH to <2.5 ug/L Alone		12 Months	No
Secondary	Effect of Pasireotide LAR vs. Octreotide LAR on Tumor Volume		12 Months	No
Secondary	Effect of Pasireotide LAR vs. Octreotide LAR on Health Related Quality of Life		12 Months	No
Secondary	Effect of Pasireotide LAR vs. Octreotide LAR as Long Term Treatment and After Cross-over on the Proportion of Patients With a Reduction of Mean GH Level to <2.5 ug/L and Nomalization of IGF-1 to Within Normal Limits (Age and Sex Related)		12 Months	No
Secondary	Effect of Pasireotide LAR and Octreotide LAR as Long Term Treatment and After Cross Over on (i)GH<2.5 ug/L and (ii) Normalized IGF-1		12 Months	No