Study of Pasireotide in Patients With Rare Tumors of Neuroendocrine Origin

This study has been terminated.
(Slow recruitment rate into this study with rare tumors of neuroendocrine origin (enrollment issues))
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00958841
First received: July 22, 2009
Last updated: June 15, 2016
Last verified: June 2016
Results First Received: April 5, 2016  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Pancreatic Neoplasm
Pituitary Neoplasm
Nelson Syndrome
Ectopic ACTH Syndrome
Intervention: Drug: pasireotide LAR

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Pasireotide LAR 60mg All 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. Patients included patients with pancreatic neuroendocrine tumors (PNETs), pituitary NETs (PiNETs), Ectopic ACTH-secreting tumor (EAS) & Nelson's syndrome.

Participant Flow:   Overall Study
    Pasireotide LAR 60mg  
STARTED     118  
Completed Month 6 (M6)     90  
Entered in Extension     63  
COMPLETED     22 [1]
NOT COMPLETED     96  
Abnormal laboratory value(s)                 1  
Abnormal test procedure result(s)                 3  
Administrative problems                 1  
Adverse Event                 8  
New cancer therapy                 5  
Withdrawal by Subject                 1  
Unsatisfactory therapeutic effect                 22  
Completed M6/did not enter extension                 27  
Discontinued prior to M*                 28  
[1] Completed = Completed extension



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The full analysis set (FAS) consisted of all enrolled patients who received at least one dose of pasireotide LAR.

Reporting Groups
  Description
Pasireotide LAR 60mg All 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. Patients included patients with pancreatic neuroendocrine tumors (PNETs), pituitary NETs (PiNETs), Ectopic ACTH-secreting tumor (EAS) & Nelson's syndrome.

Baseline Measures
    Pasireotide LAR 60mg  
Number of Participants  
[units: participants]
  118  
Age  
[units: Years]
Mean (Standard Deviation)
  45.9  (14.56)  
Gender  
[units: Participants]
 
Female     68  
Male     50  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Responders at Month 6 - Pooled Pancreatic NETs (PNETs)   [ Time Frame: 6 months ]

2.  Secondary:   Percentage of Responders at Month 6 - Individual NETs   [ Time Frame: 6 months ]

3.  Secondary:   Percentage of Responders With Probability of Success at Month 6 - Individual NETs   [ Time Frame: 6 months ]

4.  Secondary:   PNETs: Number of Patients Attaining Normalization or a More Than 50% Reduction in Primary Biochemical Tumor Marker   [ Time Frame: Baseline, month 6 ]

5.  Secondary:   PiNETs: Number of Patients Attaining Normalization or a More Than 50% Reduction in Primary Biochemical Tumor Marker   [ Time Frame: Baseline, month 6 ]

6.  Secondary:   Nelson's Syndrome: Number of Patients Attaining Normalization or a More Than 50% Reduction in Primary Biochemical Tumor Marker   [ Time Frame: Baseline, month 6 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
phone: 862-778-8300
e-mail: trialandresults.registries@novartis.com



Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00958841     History of Changes
Other Study ID Numbers: CSOM230D2203
2008-007348-32 ( EudraCT Number )
Study First Received: July 22, 2009
Results First Received: April 5, 2016
Last Updated: June 15, 2016
Health Authority: United States: Food and Drug Administration
Brazil: Ministry of Health
Canada: Health Canada
Denmark: Danish Medicines Agency
Finland: Finnish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: BfArM
Israel: Ministry of Health
Italy: The Italian Medicines Agency
Norway: Norwegian Medicines Agency
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Spain: Spanish Agency of Medicines
Sweden: Medical Products Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency