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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00958841
Registration number
NCT00958841
Ethics application status
Date submitted
22/07/2009
Date registered
13/08/2009
Date last updated
26/07/2016
Titles & IDs
Public title
Study of Pasireotide in Patients With Rare Tumors of Neuroendocrine Origin
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Scientific title
An Open Label, Multicenter, Single Arm Study of Pasireotide LAR in Patients With Rare Tumors of Neuroendocrine Origin
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Secondary ID [1]
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2008-007348-32
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Secondary ID [2]
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CSOM230D2203
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Pancreatic Neoplasm
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Pituitary Neoplasm
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Nelson Syndrome
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Ectopic ACTH Syndrome
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Condition category
Condition code
Cancer
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Pancreatic
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Neurological
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Other neurological disorders
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Metabolic and Endocrine
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Other endocrine disorders
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Other
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Research that is not of generic health relevance and not applicable to specific health categories listed above
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - pasireotide LAR
Experimental: pasireotide LAR 60mg - Patients received pasireotide LAR at 60 mg approximately once every 28 days for 6 months during the core treatment period and additional treatment cycles up to a total of 48 months during the extension phase.
Treatment: Drugs: pasireotide LAR
Investigational drug pasireotide LAR was supplied in vials with 20 mg or 40 mg powder and 2 mL vehicle was supplied in ampoules for reconstitution.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Responders at Month 6 - Pooled Pancreatic NETs (PNETs)
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Assessment method [1]
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The primary efficacy endpoint was defined as the percentage of responders at Month 6 among pooled PNET patients (insulinoma, gastrinoma, VIPoma, and glucagonoma). A responder was defined as a patient who either attained normalization or had a greater than 50% reduction from baseline of the level of the primary biochemical tumor marker at Month 6 (M6). Four insulinoma pts were excluded from analysis because of unavailability of normal ranges for the associated primary biochemical tumor marker (insulin-to-glucose ratio). One patient with VIPoma with a normal baseline was also excluded. As a result, only 20 out of 25 patients with PNET were included in the assessment of the primary endpoint, which was less than the planned sample size of 34. Therefore, the primary objective could not be assessed with sufficient power. Patients with missing Month 6 assessment were considered as non-responders. Responder analyses are reported only for indications with minimum of 6 patients.
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Timepoint [1]
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6 months
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Secondary outcome [1]
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Percentage of Responders at Month 6 - Individual NETs
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Assessment method [1]
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Percentage of responders for each of the 10 NET indications considered in the study. Responder analyses were performed for an indication only if there were at least 6 patients in the efficacy analyzable set. For all other individual indications, the numbers of patients in the efficacy analyzable sets were less than 6 and therefore no responder analyses were carried out for these indications.
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Timepoint [1]
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6 months
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Secondary outcome [2]
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Percentage of Responders With Probability of Success at Month 6 - Individual NETs
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Assessment method [2]
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Percentage of responders for each of the 10 NET indications considered in the study. Responder analyses were performed for an indication only if there were at least 6 patients in the efficacy analyzable set. For all other individual indications, the numbers of patients in the efficacy analyzable sets were less than 6 and therefore no responder analyses were carried out for these indications. The probability of success was a chance that the true responder rate was greater than 15%) for the indications gastrinoma, prolactinoma, and Nelson's syndrome.
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Timepoint [2]
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6 months
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Secondary outcome [3]
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PNETs: Number of Patients Attaining Normalization or a More Than 50% Reduction in Primary Biochemical Tumor Marker
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Assessment method [3]
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Specific primary biochemical tumor markers were used to assess the efficacy of pasireotide in PNETs. A Month 6 responder was defined as the patients who either attained normalization or greater than 50% reduction from baseline in the level of the primary biochemical tumor marker at Month 6. One gastrinoma patient had a missing primary tumor marker value at Month 6, but had a Month 5 assessment done on Day 141, which fell within the allowed window period for Month 6.
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Timepoint [3]
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Baseline, month 6
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Secondary outcome [4]
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PiNETs: Number of Patients Attaining Normalization or a More Than 50% Reduction in Primary Biochemical Tumor Marker
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Assessment method [4]
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Specific primary biochemical tumor markers were used to assess the efficacy of pasireotide in PNETs. A Month 6 responder was defined as the patients who either attained normalization or greater than 50% reduction from baseline in the level of the primary biochemical tumor marker at Month 6.
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Timepoint [4]
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Baseline, month 6
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Secondary outcome [5]
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Nelson's Syndrome: Number of Patients Attaining Normalization or a More Than 50% Reduction in Primary Biochemical Tumor Marker
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Assessment method [5]
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Six patients with Nelson's syndrome met the responder's criteria of attaining normalization or a reduction of more than 50% in primary tumor marker at Month 6.
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Timepoint [5]
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Baseline, month 6
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Eligibility
Key inclusion criteria
- Male and Female Patients at least 18 years old
- Patient who have rare tumors of neuroendocrine origin, such as tumors of the:
1. pancreas
2. pituitary glands
3. Nelson syndrome
4. ectopic-ACTH secreting tumor
- Patients who have failed standard of care treatment or for whom no standard of care
treatment exist
- Signed Informed Consent
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Patients with active gallbladder disease
- Patients with any ongoing or planned anti-neoplastic or interferon therapy
- Poorly controlled diabetes mellitus
- Female patients who are pregnant or lactating, or are of childbearing potential and
not practicing a medically acceptable method of birth control
Other protocol-defined inclusion/exclusion criteria may apply.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Terminated
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/09/2009
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/06/2015
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Sample size
Target
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Accrual to date
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Final
118
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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Novartis Investigative Site - Westmead
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Recruitment hospital [2]
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Novartis Investigative Site - Fitzroy
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Recruitment postcode(s) [1]
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2145 - Westmead
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Recruitment postcode(s) [2]
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3065 - Fitzroy
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Recruitment outside Australia
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United States of America
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California
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United States of America
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Massachusetts
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United States of America
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New York
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United States of America
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Washington
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Argentina
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Buenos Aires
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Brazil
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CE
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Brazil
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MG
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Brazil
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SP
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Canada
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Nova Scotia
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Canada
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Quebec
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France
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Angers
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France
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Bron Cedex
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France
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Le Kremlin Bicetre
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France
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Lille Cedex
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France
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Marseille cedex 05
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France
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Pessac Cedex
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France
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Reims
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France
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Strasbourg
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Germany
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Berlin
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Germany
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Erlangen
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Germany
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Frankfurt
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Germany
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Muenchen
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Germany
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Ulm
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Germany
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Würzburg
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Italy
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AN
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Italy
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FE
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Italy
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PD
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Italy
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PI
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Italy
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RM
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Mexico
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Distrito Federal
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Russian Federation
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Moscow
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Russian Federation
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Saint-Petersburg
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Spain
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Andalucia
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Spain
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Catalunya
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Thailand
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Bangkok
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Novartis Pharmaceuticals
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This study will assess the effectiveness and safety of pasireotide long-acting release in
patients who have rare tumors of neuroendocrine origin.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00958841
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Novartis Pharmaceuticals
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Address
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Novartis Pharmaceuticals
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Contact person for public queries
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00958841
Download to PDF