Study Stopped
Slow recruitment rate into this study with rare tumors of neuroendocrine origin (enrollment issues)
Study of Pasireotide in Patients With Rare Tumors of Neuroendocrine Origin
An Open Label, Multicenter, Single Arm Study of Pasireotide LAR in Patients With Rare Tumors of Neuroendocrine Origin
2 other identifiers
interventional
118
12 countries
42
Brief Summary
This study will assess the effectiveness and safety of pasireotide long-acting release in patients who have rare tumors of neuroendocrine origin.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Sep 2009
Longer than P75 for phase_2
42 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 22, 2009
CompletedFirst Posted
Study publicly available on registry
August 13, 2009
CompletedStudy Start
First participant enrolled
September 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedResults Posted
Study results publicly available
July 26, 2016
CompletedJuly 26, 2016
June 1, 2016
5.8 years
July 22, 2009
April 5, 2016
June 15, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Responders at Month 6 - Pooled Pancreatic NETs (PNETs)
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.
6 months
Secondary Outcomes (5)
Percentage of Responders at Month 6 - Individual NETs
6 months
Percentage of Responders With Probability of Success at Month 6 - Individual NETs
6 months
PNETs: Number of Patients Attaining Normalization or a More Than 50% Reduction in Primary Biochemical Tumor Marker
Baseline, month 6
PiNETs: Number of Patients Attaining Normalization or a More Than 50% Reduction in Primary Biochemical Tumor Marker
Baseline, month 6
Nelson's Syndrome: Number of Patients Attaining Normalization or a More Than 50% Reduction in Primary Biochemical Tumor Marker
Baseline, month 6
Study Arms (1)
pasireotide LAR 60mg
EXPERIMENTALPatients 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Male and Female Patients at least 18 years old
- Patient who have rare tumors of neuroendocrine origin, such as tumors of the:
- pancreas
- pituitary glands
- Nelson syndrome
- ectopic-ACTH secreting tumor
- Patients who have failed standard of care treatment or for whom no standard of care treatment exist
- Signed Informed Consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (42)
Cedars Sinai Medical Center Cedars Sinai 4
Los Angeles, California, 90048, United States
Cedars Sinai Medical Center The Pituitary Center (3)
Los Angeles, California, 90048, United States
Stanford University Medical Center SC
Stanford, California, 94304, United States
Dana Farber Cancer Institute Deptof DanaFarberCancerInst(5)
Boston, Massachusetts, 02215, United States
Mount Sinai School of Medicine Study Coordinator
New York, New York, 10029, United States
Swedish Medical Center Dept.ofSwedishMedicalCtr.(2)
Seattle, Washington, United States
Novartis Investigative Site
Buenos Aires, Buenos Aires, C1264AAA, Argentina
Novartis Investigative Site
Westmead, New South Wales, 2145, Australia
Novartis Investigative Site
Fitzroy, Victoria, 3065, Australia
Novartis Investigative Site
Fortaleza, Ceará, 60430-370, Brazil
Novartis Investigative Site
Belo Horizonte, Minas Gerais, 30130-100, Brazil
Novartis Investigative Site
Botucatu, São Paulo, 18618-970, Brazil
Novartis Investigative Site
Halifax, Nova Scotia, B3H 2Y9, Canada
Novartis Investigative Site
Montreal, Quebec, H2L 2W5, Canada
Novartis Investigative Site
Strasbourg, France, 67098, France
Novartis Investigative Site
Angers, 49033, France
Novartis Investigative Site
Bron, 69677, France
Novartis Investigative Site
Le Kremlin-Bicêtre, 94275, France
Novartis Investigative Site
Lille, 59037, France
Novartis Investigative Site
Marseille, 13385, France
Novartis Investigative Site
Pessac, 33604, France
Novartis Investigative Site
Reims, 51092, France
Novartis Investigative Site
Berlin, 10098, Germany
Novartis Investigative Site
Berlin, 13353, Germany
Novartis Investigative Site
Erlangen, 91054, Germany
Novartis Investigative Site
Frankfurt, 60590, Germany
Novartis Investigative Site
München, 80804, Germany
Novartis Investigative Site
Ulm, 89081, Germany
Novartis Investigative Site
Würzburg, 97080, Germany
Novartis Investigative Site
Ancona, AN, 60126, Italy
Novartis Investigative Site
Cona, FE, 44100, Italy
Novartis Investigative Site
Padua, PD, 35128, Italy
Novartis Investigative Site
Pisa, PI, 56124, Italy
Novartis Investigative Site
Roma, RM, 00168, Italy
Novartis Investigative Site
Mexico City, Mexico City, 14269, Mexico
Novartis Investigative Site
Moscow, 115478, Russia
Novartis Investigative Site
Moscow, 117036, Russia
Novartis Investigative Site
Saint Petersburg, 197341, Russia
Novartis Investigative Site
Málaga, Andalusia, 29010, Spain
Novartis Investigative Site
Barcelona, Catalonia, 08036, Spain
Novartis Investigative Site
Bangkok, 10330, Thailand
Novartis Investigative Site
Bangkok, 10700, Thailand
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Novartis Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 22, 2009
First Posted
August 13, 2009
Study Start
September 1, 2009
Primary Completion
June 1, 2015
Study Completion
June 1, 2015
Last Updated
July 26, 2016
Results First Posted
July 26, 2016
Record last verified: 2016-06