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.
Phase 3
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Symptomatic Refractory Resistant Carcinoid Disease
Both
Symptomatic Refractory Resistant Carcinoid Disease
Trial Information
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Outcome Measure:
Efficacy assessed by Symptoms (Bowel Movements and/or Flushing)
Outcome Time Frame:
when all randomized patients have completed the core study
Safety Issue:
No
Principal Investigator
Novartis Pharmaceuticals
Investigator Role:
Study Director
Investigator Affiliation:
Novartis Pharmaceuticals
Authority:
United States: Food and Drug Administration
Study ID:
CSOM230C2303
NCT ID:
NCT00690430
Start Date:
April 2008
Completion Date:
April 2012
Related Keywords:
- Symptomatic Refractory Resistant Carcinoid Disease
- Carcinoid
- neuroendocrine
- gastroenteropancreatic
- somatostatin analogue
- Symptomatic Refractory Resistant Carcinoid Disease
- Carcinoid Tumor
Name | Location |
|---|---|
| Scottsdale Healthcare/TGen Clinical Research Service TGen Clinical Research Service | Scottsdale, Arizona 85258 |
| Montefiore Medical Center MMC | Bronx, New York 10467 |
| St. Luke's Hospital and Health Network St. Luke's Cancer Network | Bethlehem, Pennsylvania |
| University of Arizona / Arizona Cancer Center | Tucson, Arizona 85724 |
| Loma Linda University Dept. of Loma Linda CancerCent | Loma Linda, California 92354 |
| Cedars Sinai Medical Center Cedars Sinai 4 | Los Angeles, California 90048 |
| H. Lee Moffitt Cancer Center/University of South Florida Dept of H. Lee Moffit | Tampa, Florida 33612 |
| Dana Farber Cancer Institute Gastrointestional Cancer Unit | Boston, Massachusetts 02115 |
| Duke University Medical Center Dept. of Duke Cancer Center(2) | Durham, North Carolina 27710 |
| MD Anderson Cancer Center/University of Texas Dept. of MD Anderson (9) | Houston, Texas 77030-4009 |
