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

Completed · Phase 2

Conditions studied: Cushing Disease

In brief

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

Key facts

Study ID

NCT00171951

Run by

Novartis Pharmaceuticals

People needed

19

Starts

2004-08-13

Expected to finish

2013-07-08

Last updated by the study team

2021-06-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants who have completed the 15 days of Pasireotide treatment in the CSOM230B2208 study and have achieved normalization of 24-hour urinary free cortisol. Participants who did not achieve normalization of 24 -hour urinary free cortisol may be enrolled if in the opinion of the investigator the participant is getting significant clinical benefits from treatment with Pasireotide .
• The participant did not experience any unacceptable adverse events of tolerability issues during the original 15 day treatment.
• Female participants of childbearing 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.

You may not qualify if…

• Participant who have developed poorly controlled diabetes mellitus as indicated by ketoacidosis or hemoglobin (Hgb) A1C (HgbA1C) > 10 since starting [study CSOM230B2208].
• Participant with persistent alanine aminotransferase (ALT)/ aspartate transaminase (AST) or alkaline phosphatase levels more than 2.5X upper limit of normal (ULN), serum creatinine > 2.0 X ULN, serum bilirubin > 2 X ULN.
• Participant with abnormal coagulation (Prothrombin time (PT) and partial thromboplastin time (PTT) elevated by 30% above normal limits), white blood cells (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.

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States
• Oregon Health & Sciences University Dept.ofOregonHealth&SciencesU. — Portland, Oregon, United States
• University of Pennsylvania Medical Center — Philadelphia, Pennsylvania, United States
• Novartis Investigative Site — Paris, France
• Novartis Investigative Site — Essen, Germany
• Novartis Investigative Site — München, Germany
• Novartis Investigative Site — Ancona, AN, Italy
• Novartis Investigative Site — Belfast, United Kingdom

Full record on ClinicalTrials.gov

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