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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-08-13

Study Completion Date

2013-07-08

Brief Summary

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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 assessed the long-term safety and efficacy of pasireotide in participants with Cushing's disease.

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Detailed Description

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Conditions

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Cushing Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Pasireotide 600 μg BID SC or Ramp up Dose 900 μg BID SC

Participants received pasireotide 600 micrograms (μg) twice daily (BID) subcutaneously (SC) to achieve or maintain urinary free cortisol (UFC) normalization. If UFC levels were increased at any time, participants received 900 μg BID SC, until no safety or tolerability concerns were observed as per investigators assessment. If the participant was unable to tolerate the 900 μg BID, dosing of 600 μg three times a day was given.

Group Type EXPERIMENTAL

Pasireotide

Intervention Type DRUG

Pasireotide 600 μg or 900 μg was administered as an SC injection.

Interventions

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Pasireotide

Pasireotide 600 μg or 900 μg was administered as an SC injection.

Intervention Type DRUG

Other Intervention Names

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SOM230

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No