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

NCT ID: NCT00600886

Last Updated: 2017-07-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 358 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-02-11
• Study Completion Date: 2016-03-11

Brief Summary

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

The objective of this study was 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 could proceed into the study extension.

Patients who did not respond to the treatment they were randomized to (based on month 12 assessment results) were switched to the other treatment arm at month 13.

Conditions

Acromegaly

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Pasireotide LAR

Patients in this arm received Pasireotide LAR 40 mg im depot injection, blinded, once every 28 days (± 2 days) for 12 months. Dose could be down- or up-titrated to 20 or 60 mg, respectively. Patients who responded to Pasireotide LAR (i.e. the randomized treatment) at the end of the core (Month 12), continued Pasireotide LAR treatment in the extension. Patients who did not respond to Pasireotide LAR at the end of the core (Month 12) were allowed to switch to receive Octreotide LAR in the extension.

Group Type: EXPERIMENTAL

Pasireotide

Intervention Type: DRUG

Pasireotide LAR - intramuscular (i.m.) depot injection given once every 28 days.

Octreotide LAR

Patients in this arm received Octreotide LAR 20 mg im depot injection, blinded, once every 28 days (± 2 days) for 12 months. Dose could be down- or up-titrated to 10 or 30 mg, respectively. Patients who responded to Octreotide LAR (i.e. the randomized treatment) at the end of the core (Month 12) continued Octreotide LAR treatment in the extension (up to 2 years of treatment). Patients who did not respond to Octreotide LAR at the end of the core (Month 12) were allowed to switch to receive Pasireotide LAR in the extension.

Group Type: ACTIVE_COMPARATOR

Octreotide

Intervention Type: DRUG

Octreotide LAR - i.m. depot injection given once every 28 days.

Interventions

Pasireotide

Pasireotide LAR - intramuscular (i.m.) depot injection given once every 28 days.

Intervention Type: DRUG

Octreotide

Octreotide LAR - i.m. depot injection given once every 28 days.

Intervention Type: DRUG

Other Intervention Names

SOM230

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Novartis

Role: STUDY_CHAIR

Novartis

Locations

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

Stanford University Medical Center Stanford Cancer Center (3)

Stanford, California, United States

University of Florida SC

Gainesville, Florida, United States

Johns Hopkins University School of Medicine Dept.ofJohnsHopkinsUniv.

Baltimore, Maryland, United States

University of Michigan Comprehensive Cancer Center Deptof Endocrinology&Diabetes

Ann Arbor, Michigan, 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

Oregon Health & Sciences University DeptofOregonHealth&Sciences(3)

Portland, Oregon, United States

Allegheny Endocrinology Associates

Pittsburgh, Pennsylvania, United States

University of Texas Southwestern Medical Center Danziger Research Bldg.

Dallas, Texas, United States

University of Texas/MD Anderson Cancer Center Regulatory -12

Houston, Texas, United States

Baylor College of Medicine

Houston, Texas, United States

Swedish Medical Center Dept.ofSeattle Neuroscience(2)

Seattle, Washington, United States

Novartis Investigative Site

CABA, Buenos Aires, Argentina

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Capital Federal, Buenos Aires, Argentina

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Buenos Aires, , Argentina

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Brussels, , Belgium

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Brussels, , Belgium

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Ghent, , Belgium

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Leuven, , Belgium

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Fortaleza, Ceará, Brazil

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Brasília, Federal District, Brazil

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São Luís, Maranhão, Brazil

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Curitiba, Paraná, Brazil

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Rio de Janeiro, Rio de Janeiro, Brazil

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São Paulo, São Paulo, Brazil

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Edmonton, Alberta, Canada

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Vancouver, British Columbia, Canada

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Halifax, Nova Scotia, Canada

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Montreal, Quebec, Canada

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Sherbrooke, Quebec, Canada

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Beijing, Beijing Municipality, China

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Shanghai, , China

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Bogota, Cundinamarca, Colombia

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Prague, Czech Republic, Czechia

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Aalborg, , Denmark

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Copenhagen, , Denmark

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Bois-Guillaume, , France

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Bron, , France

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Le Kremlin-Bicêtre, , France

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Marseille, , France

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Montpellier, , France

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Paris, , France

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Pessac, , France

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Berlin, , Germany

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Berlin, , Germany

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Erlangen, , Germany

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Essen, , Germany

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München, , Germany

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Athens, GR, Greece

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Piraeus, , Greece

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Budapest, , Hungary

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Jerusalem, , Israel

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Petah Tikva, , Israel

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Cona, FE, Italy

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Genova, GE, Italy

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Padua, PD, Italy

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Pisa, PI, Italy

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Roma, RM, Italy

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Torino, TO, Italy

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Napoli, , Italy

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Mexico City, Mexico City, Mexico

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Mexico City, Mexico City, Mexico

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Nijmegen, , Netherlands

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Rotterdam, , Netherlands

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Bergen, , Norway

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Oslo, , Norway

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Krakow, , Poland

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Warsaw, , Poland

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Moscow, , Russia

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Moscow, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Seoul, Korea, South Korea

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Seoul, Korea, South Korea

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Seoul, Korea, South Korea

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Seoul, , South Korea

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Seville, Andalusia, Spain

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L'Hospitalet de Llobregat, Barcelona, Spain

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Santiago de Compostela, Galicia, Spain

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Alicante, Valencia, Spain

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Linköping, , Sweden

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Malmo, , Sweden

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Uppsala, , Sweden

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Sankt Gallen, , Switzerland

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Linkou District, , Taiwan

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Taichung, , Taiwan

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Taipei, , Taiwan

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Ankara, , Turkey (Türkiye)

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Erzurum, , Turkey (Türkiye)

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Leeds, , United Kingdom

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Liverpool, , United Kingdom

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London, , United Kingdom

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Southampton, , United Kingdom

Countries

United States; Argentina; Belgium; Brazil; Canada; China; Colombia; Czechia; Denmark; France; Germany; Greece; Hungary; Israel; Italy; Mexico; Netherlands; Norway; Poland; Russia; South Korea; Spain; Sweden; Switzerland; Taiwan; Turkey (Türkiye); United Kingdom

References

Bronstein MD, Fleseriu M, Neggers S, Colao A, Sheppard M, Gu F, Shen CC, Gadelha M, Farrall AJ, Hermosillo Resendiz K, Ruffin M, Chen Y, Freda P; Pasireotide C2305 Study Group. Switching patients with acromegaly from octreotide to pasireotide improves biochemical control: crossover extension to a randomized, double-blind, Phase III study. BMC Endocr Disord. 2016 Apr 2;16:16. doi: 10.1186/s12902-016-0096-8.

Reference Type: DERIVED

PMID: 27039081 (View on PubMed)

Shanik MH, Cao PD, Ludlam WH. HISTORICAL RESPONSE RATES OF SOMATOSTATIN ANALOGUES IN THE TREATMENT OF ACROMEGALY: A SYSTEMATIC REVIEW. Endocr Pract. 2016 Mar;22(3):350-6. doi: 10.4158/EP15913.RA. Epub 2015 Oct 5.

Reference Type: DERIVED

PMID: 26437217 (View on PubMed)

Sheppard M, Bronstein MD, Freda P, Serri O, De Marinis L, Naves L, Rozhinskaya L, Hermosillo Resendiz K, Ruffin M, Chen Y, Colao A. Pasireotide LAR maintains inhibition of GH and IGF-1 in patients with acromegaly for up to 25 months: results from the blinded extension phase of a randomized, double-blind, multicenter, Phase III study. Pituitary. 2015 Jun;18(3):385-94. doi: 10.1007/s11102-014-0585-6.

Reference Type: DERIVED

PMID: 25103549 (View on PubMed)

Related Links

http://www.novartisclinicaltrials.com/webapp/etrials/searchTrial.do?trialID=660

Visit NovartisClinicalTrials.com: Pre-qualify for a trial, and view a list of trials and participating study centers.

Other Identifiers

2007-001972-36

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CSOM230C2305

Identifier Type: -

Identifier Source: org_study_id