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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00171951
First received: September 13, 2005
Last updated: February 27, 2014
Last verified: February 2014
  Purpose

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 Intervention Phase
Cushing Disease
Drug: Pasireotide
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Extension Study to Assess the Safety and Efficacy of Pasireotide in Patients With Cushing's Disease

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Long term efficacy (UFC) in patients with Cushing's disease [ Time Frame: at the end of the study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Long term safety [ Time Frame: at the end of the study ] [ Designated as safety issue: No ]
  • Tolerability [ Time Frame: at the end of the study ] [ Designated as safety issue: No ]
  • Pharmacokinetics [ Time Frame: at the end of the study ] [ Designated as safety issue: No ]
  • Development of biomarker [ Time Frame: at the end of the study ] [ Designated as safety issue: No ]

Enrollment: 19
Study Start Date: August 2004
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pasireotide Drug: Pasireotide

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00171951

Locations
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
France
Novartis Investigative Site
Paris, France, 75006
Germany
Novartis Investigative Site
Essen, Germany, 45122
Novartis Investigative Site
Muenchen, Germany, 80336
Italy
Novartis Investigative Site
Ancona, AN, Italy, 60126
United Kingdom
Novartis Investigative Site
Belfast, United Kingdom, BT12 6BA
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticlas Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00171951     History of Changes
Other Study ID Numbers: CSOM230B2208E1, 2004-002407-32
Study First Received: September 13, 2005
Last Updated: February 27, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Cushing's disease
ACTH
Cortisol
ACTH dependent Cushing's disease

Additional relevant MeSH terms:
Cushing Syndrome
Adrenocortical Hyperfunction
Pituitary ACTH Hypersecretion
Adrenal Gland Diseases
Endocrine System Diseases
Hyperpituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on August 01, 2014