Extension Study to Assess the Safety and Efficacy of Pasireotide in Patients With Cushing's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00171951
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : November 16, 2016
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
Cushing's disease is a rare serious condition that is caused by an adrenocorticotropic hormone (ACTH) secreting pituitary adenoma. This study will assess the long-term safety and efficacy of pasireotide in patients with Cushing's disease.

Condition or disease Intervention/treatment Phase
Cushing Disease Drug: Pasireotide Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Extension Study to Assess the Safety and Efficacy of Pasireotide in Patients With Cushing's Disease
Study Start Date : August 2004
Actual Primary Completion Date : July 2013
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Pasireotide

Arm Intervention/treatment
Experimental: Pasireotide Drug: Pasireotide

Primary Outcome Measures :
  1. Long term efficacy (UFC) in patients with Cushing's disease [ Time Frame: at the end of the study ]

Secondary Outcome Measures :
  1. Long term safety [ Time Frame: at the end of the study ]
  2. Tolerability [ Time Frame: at the end of the study ]
  3. Pharmacokinetics [ Time Frame: at the end of the study ]
  4. Development of biomarker [ Time Frame: at the end of the study ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients who have completed the 15 days of Pasireotide treatment in the CSOM230B2208 study and have achieved normalization of 24-hour urinary free cortisol. Patients who did not achieve normalization of 24 -hour urinary free cortisol may be enrolled if in the opinion of the investigator the patient is getting significant clinical benefits from treatment with Pasireotide .
  • The patient did not experience any unacceptable adverse events of tolerability issues during the original 15 day treatment.
  • Female patients of child bearing potential who have not undergone clinically documented total hysterectomy and/or ovariectomy, or tubal ligation must agree to use barrier contraception throughout the course of the extension study, and for one month after the study has ended

Exclusion Criteria:

  • Patients who have developed poorly controlled diabetes mellitus as indicated by ketoacidosis or HgbA1C > 10 since starting [study CSOM230B2208]
  • Patients with persistent ALT/AST or alkaline phosphatase levels more than 2.5X ULN, serum creatinine > 2.0 X ULN, serum bilirubin > 2 X ULN
  • Patients with abnormal coagulation (PT and PTT elevated by 30% above normal limits), WBC <3.0x1'000'000'000/L; Hgb <12.0g/dL for females, Hgb <13.0g/dL for males; PLT <100x1'000'000'000/L

Other protocol-defined inclusion / exclusion criteria may apply.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00171951

United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, Oregon
Oregon Health & Sciences University Dept.ofOregonHealth&SciencesU.
Portland, Oregon, United States, 97239
United States, Pennsylvania
University of Pennsylvania Medical Center
Philadelphia, Pennsylvania, United States, 19104-6149
Novartis Investigative Site
Paris, France, 75006
Novartis Investigative Site
Essen, Germany, 45122
Novartis Investigative Site
Muenchen, Germany, 80336
Novartis Investigative Site
Ancona, AN, Italy, 60126
United Kingdom
Novartis Investigative Site
Belfast, United Kingdom, BT12 6BA
Sponsors and Collaborators
Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticlas Novartis Pharmaceuticals

Additional Information:
Publications of Results:
Responsible Party: Novartis Pharmaceuticals Identifier: NCT00171951     History of Changes
Other Study ID Numbers: CSOM230B2208E1
2004-002407-32 ( EudraCT Number )
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: November 16, 2016
Last Verified: November 2016

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Cushing's disease
ACTH dependent Cushing's disease

Additional relevant MeSH terms:
Pituitary ACTH Hypersecretion
ACTH-Secreting Pituitary Adenoma
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Pituitary Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs