Extension Study to Assess the Safety and Efficacy of Pasireotide in Patients With Cushing's Disease
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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.
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Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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.
Pituitary ACTH Hypersecretion
ACTH-Secreting Pituitary Adenoma
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Endocrine Gland Neoplasms
Neoplasms by Site
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs