Safety and Efficacy of Pasireotide Long Acting Release vs. Octreotide Long Acting Release in Patients With Metastatic Carcinoid Disease (LAR)
This study has been completed.
Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00690430
First received: May 15, 2008
Last updated: December 5, 2012
Last verified: December 2012
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Purpose
The purpose of thie randomized, multicenter, Phase III study is to compare the efficacy of pasierotide LAR and octreotide LAR in patients whose disease-related symptoms are inadequately controlled by currently available somatostatin analogues.
| Condition | Intervention | Phase |
|---|---|---|
|
Symptomatic Refractory Resistant Carcinoid Disease |
Drug: Pasireotide Drug: Octreotide |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| 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. |
Resource links provided by NLM:
Further study details as provided by Novartis:
Primary Outcome Measures:
- Efficacy assessed by Symptoms (Bowel Movements and/or Flushing) [ Time Frame: when all randomized patients have completed the core study ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Safety/tolerability of pasireotide LAR assessed by AEs, SAEs, and labs Tumor response by RECIST Biochemical parameter, 5-HIAA Quality of Life assessed by FACIT-D Questionnaire [ Time Frame: when all randomized patients have completed the core study ] [ Designated as safety issue: No ]
| Enrollment: | 186 |
| Study Start Date: | April 2008 |
| Study Completion Date: | April 2012 |
| Primary Completion Date: | April 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Pasireotide |
Drug: Pasireotide
Pasireotide LAR 60mg i.m. injection - patients may also receive pasireotide 600 µg s.c 3 times a day for symptom control as needed
Other Name: SOM230
|
| Active Comparator: Octreotide |
Drug: Octreotide
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
Other Name: Sadostatin LAR
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00690430
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Show 60 Study LocationsSponsors and Collaborators
Novartis Pharmaceuticals
Investigators
| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
More Information
Additional Information:
No publications provided
| Responsible Party: | Novartis ( Novartis Pharmaceuticals ) |
| ClinicalTrials.gov Identifier: | NCT00690430 History of Changes |
| Other Study ID Numbers: | CSOM230C2303, 2007-000739-25 |
| Study First Received: | May 15, 2008 |
| Last Updated: | December 5, 2012 |
| Health Authority: | United States: Food and Drug Administration Argentina: Ministry of Health Austria: Agency for Health and Food Safety Belgium: Directorate general for the protection of Public health: Medicines Brazil: Ministry of Health European Union: European Medicines Agency Canada: Health Canada France: Ministry of Health Germany: Ministry of Health Israel: Ministry of Health Italy: Ministry of Health Netherlands: Independent Ethics Committee Norway: The National Committees for Research Ethics Poland: Ministry of Health Spain: Ministry of Health Sweden: Institutional Review Board United Kingdom: Research Ethics Committee |
Keywords provided by Novartis:
|
Carcinoid neuroendocrine gastroenteropancreatic somatostatin analogue Symptomatic Refractory Resistant Carcinoid Disease |
Additional relevant MeSH terms:
|
Carcinoid Tumor Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue |
Octreotide Somatostatin Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Gastrointestinal Agents Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 16, 2013