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Symptomatic Refractory Resistant Carcinoid DiseasePhase 3NCT00690430

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

A Phase 3 study testing Pasireotide and Octreotide in people with Symptomatic Refractory Resistant Carcinoid Disease, run by Novartis Pharmaceuticals at 62 sites in 16 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Pasireotide and Octreotide
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
186 participants
Where
62 sitesin 16 countries
Study dates
Apr 2008to Apr 2012
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

62 sites in 16 countries.

62 sites in 16 countries

United States10 sites

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

    Bethlehem, Pennsylvania

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

    Durham, North Carolina, 27710

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

    Houston, Texas, 77030-4009

  • Loma Linda University Dept. of Loma Linda CancerCent

    Loma Linda, California, 92354

  • Cedars Sinai Medical Center Cedars Sinai 4

    Los Angeles, California, 90048

  • Mount Sinai School of Medicine Study Coordinator

    New York, New York, 10029

  • Scottsdale Healthcare/TGen Clinical Research Service TGen Clinical Research Service

    Scottsdale, Arizona, 85258

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

    Tampa, Florida, 33612

  • Montefiore Medical Center MMC

    The Bronx, New York, 10467

  • University of Arizona / Arizona Cancer Center

    Tucson, Arizona, 85724

Other trials in United States

Italy8 sites

  • Novartis Investigative Site

    Bologna, BO, 40138

  • Novartis Investigative Site

    Milan, MI, 20132

  • Novartis Investigative Site

    Milan, MI, 20141

  • Novartis Investigative Site

    Milan, MI, 20162

  • Novartis Investigative Site

    Modena, MO, 41100

  • Novartis Investigative Site

    Orbassano, TO, 10043

  • Novartis Investigative Site

    Perugia, PG, 06100

  • Novartis Investigative Site

    Roma, RM, 00168

Other trials in Italy

France7 sites

  • Novartis Investigative Site

    Clichy, 92110

  • Novartis Investigative Site

    Dijon, 21079

  • Novartis Investigative Site

    Lyon, 69437

  • Novartis Investigative Site

    Marseille, 13385

  • Novartis Investigative Site

    Montpellier, 34295

  • Novartis Investigative Site

    Nice, France, 06202

  • Novartis Investigative Site

    Strasbourg, France, 67098

Other trials in France

Germany6 sites

  • Novartis Investigative Site

    Bad Berka, 99438

  • Novartis Investigative Site

    Berlin, Germany, 12200

  • Novartis Investigative Site

    Berlin, 13353

  • Novartis Investigative Site

    Heidelberg, 69120

  • Novartis Investigative Site

    Mainz, Germany, D-55101

  • Novartis Investigative Site

    München, 80336

Other trials in Germany

Sweden6 sites

  • Novartis Investigative Site

    Jönköping, SE-551 85

  • Novartis Investigative Site

    Linköping, SE-581 85

  • Novartis Investigative Site

    Lund, SE-221 85

  • Novartis Investigative Site

    Stockholm, SE-141 86

  • Novartis Investigative Site

    Stockholm, SE-171 76

  • Novartis Investigative Site

    Uppsala, SE-751 85

Other trials in Sweden

United Kingdom6 sites

  • Novartis Investigative Site

    Basingstoke, RG24 9NA

  • Novartis Investigative Site

    Birmingham, B15 2TH

  • Novartis Investigative Site

    Glasgow, G12 0YN

  • Novartis Investigative Site

    London

  • Novartis Investigative Site

    Sheffield, South Yorkshire, S10 2JF

  • Novartis Investigative Site

    Withington, Greater Manchester, M20 4BX

Other trials in United Kingdom

Austria3 sites

  • Novartis Investigative Site

    Graz, 8036

  • Novartis Investigative Site

    Salzburg, 5020

  • Novartis Investigative Site

    Vienna, A-1090

Other trials in Austria

Canada3 sites

  • Novartis Investigative Site

    Calgary, Alberta, T2N 2T9

  • Novartis Investigative Site

    Halifax, Nova Scotia, B3H 2Y9

  • Novartis Investigative Site

    Montreal, Quebec, H3A 1A1

Other trials in Canada

Argentina2 sites

  • Novartis Investigative Site

    Buenos Aires, Buenos Aires, C1264AAA

  • Novartis Investigative Site

    Buenos Aires, Buenos Aires, C1426ANZ

Other trials in Argentina

Belgium2 sites

  • Novartis Investigative Site

    Brussels, 1200

  • Novartis Investigative Site

    Ghent, 9000

Other trials in Belgium

Norway2 sites

  • Novartis Investigative Site

    Tromsø, 9038

  • Novartis Investigative Site

    Trondheim, N-7006

Other trials in Norway

Poland2 sites

  • Novartis Investigative Site

    Gdansk, Poland, 80-958

  • Novartis Investigative Site

    Gliwice, Silesian Voivodeship, 44-101

Other trials in Poland

Spain2 sites

  • Novartis Investigative Site

    L'Hospitalet de Llobregat, Catalonia, 08907

  • Novartis Investigative Site

    Santiago de Compostela, Galicia, 15706

Other trials in Spain

Brazil1 site

  • Novartis Investigative Site

    Fortaleza, Ceará, 60430-370

Other trials in Brazil

Israel1 site

  • Novartis Investigative Site

    Jerusalem, 91120

Other trials in Israel

Singapore1 site

  • Novartis Investigative Site

    Singapore, Singapore, 169610

Other trials in Singapore

About this study

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.

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.

Being tested
Pasireotide, Octreotide
Keywords
Carcinoid, neuroendocrine, gastroenteropancreatic, somatostatin analogue, Symptomatic Refractory Resistant Carcinoid Disease
Medical subject headings
Carcinoid Tumor

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PasireotideDrug

    Also called SOM230

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

  • OctreotideDrug

    Also called Sadostatin LAR

    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

Study groups in NCT00690430
Study groupRoleWhat they receive
Pasireotide LARActive comparatorPatients 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.
Receives: Drug: Pasireotide
Octreotide LARActive comparatorPatients 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.
Receives: Drug: Octreotide

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Month 6

Secondary outcomes (9)

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

    Percent change from Baseline in mean daily bowel movements at Month 6 were compared between the two treatment groups using ANCOVA model with treatment as the main effect and symptom levels at Baseline (e.g. mean daily bowel movement at Baseline) and randomization stratum (D+F or D) as covariates. Percentage change = (Month 6 - baseline)/baseline.

    Measured: 6 months

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

    Percent change from Baseline in total number of flushing episodes comprising Month 6 were compared between the two treatment groups using ANCOVA model with treatment as the main effect and symptom levels at Baseline (e.g. total number of flushing episodes at Baseline) and randomization stratum (D+F or F) as covariates.

    Measured: 6 months

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

    Measured: Month 6

  4. Objective Tumor Response Rate Assessed by Investigator

    Baseline evaluations were to include Triphasic CT scan or MRI of the abdomen. Triphasic CT or MRIs were to be read by same radiologist at each assessment, measuring the same target and non-target lesions and accounting for all lesions that were present at Baseline. All known disease was accounted for when assessing objective tumor status. Current objective tumor status was to be captured on Tumor Assessment CRF. Objective response rate was defined by RECIST criteria: Partial response (PR) must have ≥ 30% decrease in the sum of longest diameter of all target lesions, from the baseline sum. Complete response (CR) must have disappearance of all target and non-target lesions. For CR or PR, tumor measurements must be confirmed by 2nd assessments within 4 weeks. Progression = 20% increase in the sum of longest diameter of all target lesions, from smallest sum of longest diameter of all target lesions recorded at or after baseline; or a new lesion; or progression of non-target lesions.

    Measured: Month 6

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

    Disease control rate (DCR) is the proportion of patients with a best overall response of Complete Response (CR) or Partial Response (PR) or Stable Disease (SD). Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the longest diameter of all target lesions, taking as reference the baseline sum of the longest diameters. Progressive Disease (PD): At least a 20% increase in the sum of the longest diameter of all measured target lesions, taking as reference the smallest sum of longest diameter of all target lesions recorded at or after baseline, or a new lesion; or progression of non-target lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for PD. Unknown (UNK) Progression has not been documented and one or more target lesions have not been assessed or have been assessed using a different method than baseline.

    Measured: Month 6

  6. Pasireotide LAR vs. Octreotide LAR on Quality of Life Assessed by FACIT-D Questionnaire

    Measured: Month 6

  7. Pasireotide LAR vs. Octreotide LAR on Time to Symptom Progression

    Measured: Month 6

  8. Pasireotide LAR vs. Octreotide LAR on Duration of Symptom Response

    Measured: Month 6

  9. Assess the Proportion of Patients Who Achieved at Least a 30% Reduction in Frequency of Bowel Movements

    Measured: Month 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jun 2008 (estimated)
  2. Study startApr 2008
  3. Primary completionApr 2012
  4. Study completionApr 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
186 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00690430
Sponsor's protocol ID
CSOM230C2303
Other IDs
2007-000739-25
Status last verified
Jun 2013
First submitted
15 May 2008
Last updated
30 Jul 2013
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Pasireotide and Octreotide in people with Symptomatic Refractory Resistant Carcinoid Disease, run by Novartis Pharmaceuticals at 62 sites in 16 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 62 sites in United States, Italy, France, Germany, Sweden and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Jul 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Patients Who Achieved Clinical Symptom Improvement by Randomization Stratum and Treatment. (time frame: Month 6). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00690430.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2013; AzTrials last refreshed its copy on 7 Nov 2026.

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