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An Open Label, Multicenter, Single Arm Study of Pasireotide LAR in Patients With Rate Tumors of Neuroendocrine Origin


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Pancreatic Neoplasm, Pituitary Neoplasm, Nelson Syndrome, Ectopic ACTH Syndrome

Thank you

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 SCStanford, California  94304
Dana Farber Cancer Institute Deptof DanaFarberCancerInst(5)Boston, Massachusetts  02115
Mount Sinai School of Medicine Study CoordinatorNew York, New York  10029
Swedish Medical Center Dept.ofSwedishMedicalCtr.(2)Seattle, Washington  
Cedars Sinai Medical Center Cedars Sinai 4Los Angeles, California  90048