An Open Label, Multicenter, Single Arm Study of Pasireotide LAR in Patients With Rate Tumors of Neuroendocrine Origin
Phase 2
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
Pancreatic Neoplasm, Pituitary Neoplasm, Nelson Syndrome, Ectopic ACTH Syndrome
Both
Pancreatic Neoplasm, Pituitary Neoplasm, Nelson Syndrome, Ectopic ACTH Syndrome
Trial Information
An Open Label, Multicenter, Single Arm Study of Pasireotide LAR in Patients With Rate Tumors of Neuroendocrine Origin
Inclusion Criteria:
- Male and Female Patients at least 18 years old
- Patient who have rare tumors of neuroendocrine origin, such as tumors of the:
1. pancreas
2. pituitary glands
3. Nelson syndrome
4. ectopic-ACTH secreting tumor
- Patients who have failed standard of care treatment or for whom no standard of care
treatment exist
- Signed Informed Consent
Exclusion Criteria:
- 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
Other protocol-defined inclusion/exclusion criteria may apply.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Change in disease specific primary biochemical tumor markers
Outcome Time Frame:
6 months
Safety Issue:
No
Principal Investigator
Novartis Pharmaceuticals
Investigator Role:
Study Director
Investigator Affiliation:
Novartis Pharmaceuticals
Authority:
United States: Food and Drug Administration
Study ID:
CSOM230D2203
NCT ID:
NCT00958841
Start Date:
September 2009
Completion Date:
January 2014
Related Keywords:
- Pancreatic Neoplasm
- Pituitary Neoplasm
- Nelson Syndrome
- Ectopic ACTH Syndrome
- Rare tumors of neuroendocrine origin
- NETs of the pancreatic
- Pituitary NETs
- EAS Tumors
- Nelson's Syndrome
- ACTH Syndrome, Ectopic
- Cushing Syndrome
- Neoplasms
- Nelson Syndrome
- Pancreatic Neoplasms
- Pituitary Neoplasms
- Cardiac Complexes, Premature
Name | Location |
|---|---|
| Cedars Sinai Medical Center The Pituitary Center (3) | Los Angeles, California 90048 |
| Stanford University Medical Center SC | Stanford, California 94304 |
| Dana Farber Cancer Institute Deptof DanaFarberCancerInst(5) | Boston, Massachusetts 02115 |
| Mount Sinai School of Medicine Study Coordinator | New York, New York 10029 |
| Swedish Medical Center Dept.ofSwedishMedicalCtr.(2) | Seattle, Washington |
| Cedars Sinai Medical Center Cedars Sinai 4 | Los Angeles, California 90048 |
