Efficacy and Safety of Pasireotide Long Acting Release vs. Octreotide Long Acting Release in Patients With Metastatic Carcinoid Disease

NCT00690430 | Completed Phase 3 Results DMC

• 2 other identifiers: CSOM230C23032007-000739-25
• Study Type: interventional
• Target: 186
• Locations: 16 countries
• Sites: 62

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.

Conditions

Symptomatic Refractory Resistant Carcinoid Disease

Keywords

Carcinoid; neuroendocrine; gastroenteropancreatic; somatostatin analogue; Symptomatic Refractory Resistant Carcinoid Disease

Outcome Measures

Primary Outcomes (1)

• Percentage of Patients Who Achieved Clinical Symptom Improvement by Randomization Stratum and Treatment.

  Percentage of patients who received clinical benefit in symptom (diarrhea and/or flushing) improvement as: Diarrhea (D)+Flushing (F): Patients with a daily mean number (#) of at least four bowel movements and a total of five or more flushing episodes. Clinical Benefit Response Criteria (CBRC): \<4 daily mean bowel movements AND at least 20% reduction from Baseline in the daily mean # of bowel movements AND any reduction in the total # of flushing episodes compared with Baseline. (D) Patients with a daily mean # of at least four bowel movements and a total # of \<5 flushing episodes. (CBRC) \<4 daily mean bowel movements AND at least a 20% reduction from Baseline in the daily mean # of bowel movements. (F) Patients with a total # of at least 14 flushing episodes and a daily mean # of \<4 bowel movements (CBRC) At least a 30% reduction from Baseline in the total # of flushing episodes.

  Month 6

Secondary Outcomes (9)

• Improvement in Daily Mean Number of Diarrhea Bowel Movement Episodes by Randomization Stratum and Treatment.

  6 months

• Improvement in Daily Mean Number of Flushing Episodes by Randomization Stratum and Treatment.

  6 months

• Pasireotide LAR vs. Octreotide LAR on Time to Symptom Response.

  Month 6

• Objective Tumor Response Rate Assessed by Investigator

  Month 6

• Pasireotide LAR vs. Octreotide LAR on Disease Control Rate Based on RECIST Criteria

  Month 6

Study Arms (2)

Pasireotide LAR

ACTIVE COMPARATOR

Patients assigned to pasireotide LAR will receive a 60 mg dose of pasireotide LAR i.m. depot injection once every 28 days (+/- 3 days) for 6 months at visits 2, 4, 5, 6, 7 and 8. A dose reduction to 40 mg is permitted if tolerability issues arise. In addition, after 24 hours of the first LAR injections the patients were permitted to use pasireotide s.c. formulation for breakthrough symptoms as needed.

Drug: Pasireotide

Octreotide LAR

ACTIVE COMPARATOR

Patients assigned to octreotide LAR will receive a 40mg dose of octreotide LAR i.m. depot injection once every 28 days (+/- 3 days) for 6 months at visits 2, 4, 5, 6, 7 and 8. A dose reduction to 30 mg is permitted if tolerability issues arise. Patients requiring a dose reduction are to return to the higher dose once the tolerability issue is resolved, if required for efficacy In addition, after 24 hours of the first LAR injections the patients were permitted to use octreotide s.c. formulation for breakthrough symptoms as needed.

Drug: Octreotide

Interventions

Pasireotide DRUG

Pasireotide LAR 60mg i.m. injection - patients may also receive pasireotide 600 µg s.c 3 times a day for symptom control as needed

Also known as: SOM230

Pasireotide LAR

Octreotide DRUG

Octreotide LAR 40mg i.m. depot injection - Patients may also receive octreotide 100 µg s.c. 3 times a day for symptom control as needed

Also known as: Sadostatin LAR

Octreotide LAR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (62)

Scottsdale Healthcare/TGen Clinical Research Service TGen Clinical Research Service

Scottsdale, Arizona, 85258, United States

Location

University of Arizona / Arizona Cancer Center

Tucson, Arizona, 85724, United States

Location

Loma Linda University Dept. of Loma Linda CancerCent

Loma Linda, California, 92354, United States

Location

Cedars Sinai Medical Center Cedars Sinai 4

Los Angeles, California, 90048, United States

Location

H. Lee Moffitt Cancer Center/University of South Florida Dept of H. Lee Moffit

Tampa, Florida, 33612, United States

Location

Mount Sinai School of Medicine Study Coordinator

New York, New York, 10029, United States

Location

Montefiore Medical Center MMC

The Bronx, New York, 10467, United States

Location

Duke University Medical Center Dept. of Duke Cancer Center(2)

Durham, North Carolina, 27710, United States

Location

St. Luke's Hospital and Health Network St. Luke's Cancer Network

Bethlehem, Pennsylvania, United States

Location

MD Anderson Cancer Center/University of Texas Dept. of MD Anderson (9)

Houston, Texas, 77030-4009, United States

Location

Novartis Investigative Site

Buenos Aires, Buenos Aires, C1264AAA, Argentina

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Novartis Investigative Site

Buenos Aires, Buenos Aires, C1426ANZ, Argentina

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Novartis Investigative Site

Graz, 8036, Austria

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Novartis Investigative Site

Salzburg, 5020, Austria

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Novartis Investigative Site

Vienna, A-1090, Austria

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Novartis Investigative Site

Brussels, 1200, Belgium

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Novartis Investigative Site

Ghent, 9000, Belgium

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Novartis Investigative Site

Fortaleza, Ceará, 60430-370, Brazil

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Novartis Investigative Site

Calgary, Alberta, T2N 2T9, Canada

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Novartis Investigative Site

Halifax, Nova Scotia, B3H 2Y9, Canada

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Novartis Investigative Site

Montreal, Quebec, H3A 1A1, Canada

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Novartis Investigative Site

Nice, France, 06202, France

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Novartis Investigative Site

Strasbourg, France, 67098, France

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Novartis Investigative Site

Clichy, 92110, France

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Novartis Investigative Site

Dijon, 21079, France

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Novartis Investigative Site

Lyon, 69437, France

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Novartis Investigative Site

Marseille, 13385, France

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Novartis Investigative Site

Montpellier, 34295, France

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Novartis Investigative Site

Berlin, Germany, 12200, Germany

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Novartis Investigative Site

Mainz, Germany, D-55101, Germany

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Novartis Investigative Site

Bad Berka, 99438, Germany

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Novartis Investigative Site

Berlin, 13353, Germany

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Novartis Investigative Site

Heidelberg, 69120, Germany

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Novartis Investigative Site

München, 80336, Germany

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Novartis Investigative Site

Jerusalem, 91120, Israel

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Novartis Investigative Site

Bologna, BO, 40138, Italy

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Novartis Investigative Site

Milan, MI, 20132, Italy

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Novartis Investigative Site

Milan, MI, 20141, Italy

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Novartis Investigative Site

Milan, MI, 20162, Italy

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Novartis Investigative Site

Modena, MO, 41100, Italy

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Novartis Investigative Site

Perugia, PG, 06100, Italy

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Novartis Investigative Site

Roma, RM, 00168, Italy

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Novartis Investigative Site

Orbassano, TO, 10043, Italy

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Novartis Investigative Site

Tromsø, 9038, Norway

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Novartis Investigative Site

Trondheim, N-7006, Norway

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Novartis Investigative Site

Gdansk, Poland, 80-958, Poland

Location

Novartis Investigative Site

Gliwice, Silesian Voivodeship, 44-101, Poland

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Novartis Investigative Site

Singapore, Singapore, 169610, Singapore

Location

Novartis Investigative Site

L'Hospitalet de Llobregat, Catalonia, 08907, Spain

Location

Novartis Investigative Site

Santiago de Compostela, Galicia, 15706, Spain

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Novartis Investigative Site

Jönköping, SE-551 85, Sweden

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Novartis Investigative Site

Linköping, SE-581 85, Sweden

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Novartis Investigative Site

Lund, SE-221 85, Sweden

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Novartis Investigative Site

Stockholm, SE-141 86, Sweden

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Novartis Investigative Site

Stockholm, SE-171 76, Sweden

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Novartis Investigative Site

Uppsala, SE-751 85, Sweden

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Novartis Investigative Site

Withington, Greater Manchester, M20 4BX, United Kingdom

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Novartis Investigative Site

Sheffield, South Yorkshire, S10 2JF, United Kingdom

Location

Novartis Investigative Site

Basingstoke, RG24 9NA, United Kingdom

Location

Novartis Investigative Site

Birmingham, B15 2TH, United Kingdom

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Novartis Investigative Site

Glasgow, G12 0YN, United Kingdom

Location

Novartis Investigative Site

London, United Kingdom

Location

Related Links

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

MeSH Terms

Conditions

Carcinoid Tumor

Interventions

pasireotide; Octreotide

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2008
• First Posted: June 4, 2008
• Study Start: April 1, 2008
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: July 30, 2013
• Results First Posted: July 30, 2013

Record last verified: 2013-06

Locations

US (10); NO (2); SE (6); BR (1); FR (7); CA (3); AU (3); SG (1); ES (2); IL (1); IT (8); PL (2); BE (2); AR (2); DE (6); GB (6)