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Extension Study to Assess the Safety and Efficacy of Pasireotide in Patients With Cushing's Disease
This study is ongoing, but not recruiting participants.
Sponsored by: Novartis
Information provided by: Novartis
ClinicalTrials.gov Identifier: NCT00171951
  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 II

MedlinePlus related topics: Cushing's Syndrome
Drug Information available for: Hydrocortisone Cortisol 21-phosphate Cortisol succinate Hydrocortamate Hydrocortisone 21-sodium succinate Hydrocortisone acetate Hydrocortisone cypionate Hydrocortisone hemisuccinate Proctofoam-HC Pasireotide
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: Extension Study to Assess the Safety and Efficacy of Pasireotide in Patients With Cushing's Disease

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Long term efficacy (UFC) in patients with Cushing's disease

Secondary Outcome Measures:
  • Long term safety
  • Tolerability
  • Pharmacokinetics
  • Development of biomarker

Estimated Enrollment: 26
Study Start Date: August 2004
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00171951

Locations
United States, California
Los Angeles, California, United States, 90048
United States, Massachusetts
Boston, Massachusetts, United States, 02114
United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Wisconsin
Milwaukee, Wisconsin, United States, 53215
Sponsors and Collaborators
Novartis
Investigators
Study Chair: Novartis Novartis
  More Information

Study ID Numbers: CSOM230B2208E1
Study First Received: September 13, 2005
Last Updated: August 6, 2007
ClinicalTrials.gov Identifier: NCT00171951  
Health Authority: United States: Food and Drug Administration

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

Study placed in the following topic categories:
Hypothalamic Diseases
Hydrocortisone
Pituitary Diseases
Cortisol succinate
Cushing Syndrome
Adrenal Gland Diseases
Endocrine System Diseases
Central Nervous System Diseases
Brain Diseases
Adrenocortical Hyperfunction
Pituitary ACTH Hypersecretion
Endocrinopathy
Hydrocortisone acetate

Additional relevant MeSH terms:
Hyperpituitarism
Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009