Safety and Efficacy of LCI699 in Cushing's Disease Patients

This study is currently recruiting participants.

Verified April 2013 by Novartis

Sponsor:

Information provided by (Responsible Party):

Novartis ( Novartis Pharmaceuticals )

ClinicalTrials.gov Identifier:

NCT01331239

First received: April 6, 2011

Last updated: April 5, 2013

Last verified: April 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

April 6, 2011

Last Updated Date

April 5, 2013

Start Date ^ICMJE

March 2011

Estimated Primary Completion Date

August 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Change in 24 hour urine free cortisol concentration [ Time Frame: baseline, 10 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Change in 24 hour urine free cortisol concentration [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]

Change History

Complete list of historical versions of study NCT01331239 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Changes on steroid hormones of the HPA-axis in plasma, urine and saliva [ Time Frame: baseline, 10 weeks ] [ Designated as safety issue: No ]
Changes in metabolic abnormalities, e.g. insulin, Hemoglobin A1C (HbA1C) [ Time Frame: baseline, 10 weeks ] [ Designated as safety issue: No ]
Safety and tolerability of multiple doses of LCI699 [ Time Frame: baseline, 10 weeks ] [ Designated as safety issue: Yes ]
Change in 24 hour urine free cortisol concentration [ Time Frame: baseline, 22 weeks ] [ Designated as safety issue: No ]
Safety and tolerability of multiple doses of LCI699 [ Time Frame: baseline, 22 weeks ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Changes in hormone levels, e.g. testosterone, estradiol [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
Changes in metabolic abnormalities, e.g. insulin, Hemoglobin A1C (HbA1C) [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Safety and Efficacy of LCI699 in Cushing's Disease Patients

Official Title ^ICMJE

A Proof of Concept, Open-label, Forced Titration, Multi-center Study to Assess the Safety/Tolerability and Efficacy of 10-weeks Treatment of LCI699 Followed by a 12 - Week Treatment Period of LCI699 in Patients With Cushing's Disease

Brief Summary

This exploratory study is a proof of concept study to determine whether LCI699 can safely reduce the level of urinary free cortisol in patients with Cushing's disease. In addition, this study will evaluate the long term efficacy and safety of LCI699 including an additional 12 week of treatment followed by a 12 month long term optional extension.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Cushing's Disease

Intervention ^ICMJE

Drug: LCI699

Study Arm (s)

Experimental: LCI699

Ascending dose from 2mg bid or 5 mg bid, up to 50 mg bid

Intervention: Drug: LCI699

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2014

Estimated Primary Completion Date

August 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Patients with a confirmed diagnosis of Cushing's Disease (persistent or recurrent) as evidenced by increased 24-hour urine free cortisol (UFC), normal or increased morning plasma Adrenocorticotropic Hormone (ACTH), and pituitary origin of excess ACTH.
Patients with de novo Cushing's disease can be included only if they are not considered candidate for surgery

Exclusion Criteria:

Patients treated with mitotane 6 months prior to Visit 1
Patients with compression of the optic chiasm
Patients with a known inherited syndrome as the cause for hormone over secretion
Patients with Cushing's syndrome due to ectopic ACTH secretion or adrenal Cushing's syndrome
Patients with pseudo-Cushing's syndrome
Patients who are not biochemically euthyroid
Diabetic patients with poorly controlled diabetes (HbA1c >9%)
Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for 1 week after completion of dosing.

Other protocol-defined inclusion/exclusion criteria may apply

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Novartis Pharmaceuticals	1-888-669-6682
Contact: Novartis Pharmaceuticals	+41-61-324-1111 ext +41613241111

Location Countries ^ICMJE

United States, France, Italy, Japan

Administrative Information

NCT Number ^ICMJE

NCT01331239

Other Study ID Numbers ^ICMJE

CLCI699C2201, 2010-022403-22

Has Data Monitoring Committee

Responsible Party

Novartis ( Novartis Pharmaceuticals )

Study Sponsor ^ICMJE

Novartis Pharmaceuticals

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Novartis Pharmaceuticals

Information Provided By

Novartis

Verification Date

April 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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