Status:
COMPLETED
Efficacy and Safety of Pasireotide Long Acting Release vs. Octreotide Long Acting Release in Patients With Metastatic Carcinoid Disease
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Symptomatic Refractory Resistant Carcinoid Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- 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.
- Exclusion criteria:
- 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
Exclusion
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
186 Patients enrolled
Trial Details
Trial ID
NCT00690430
Start Date
April 1 2008
End Date
April 1 2012
Last Update
July 30 2013
Active Locations (62)
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1
Scottsdale Healthcare/TGen Clinical Research Service TGen Clinical Research Service
Scottsdale, Arizona, United States, 85258
2
University of Arizona / Arizona Cancer Center
Tucson, Arizona, United States, 85724
3
Loma Linda University Dept. of Loma Linda CancerCent
Loma Linda, California, United States, 92354
4
Cedars Sinai Medical Center Cedars Sinai 4
Los Angeles, California, United States, 90048