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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...
Date First Received: April 6, 2011
Last Updated: April 6, 2011
Verified by: Novartis, April 2011
Clinical Trial Phase: Phase 2 | Start Date: March 2011
Overall Status: Recruiting
Estimated Enrollment: 12
Condition Keyword(s):
Additional Keyword(s) Provided by Clinical Trial Investigators:
Intervention(s):
Condition MeSH Term(s), Assigned with an Experimental Algorithm:
Intervention MeSH Term(s), Assigned with an Experimental Algorithm:
Brief Summary
Official Title: “A Proof of Concept, Open-label, Forced Titration, Multi-center Study to Assess the Safety/Tolerability and Efficacy of 10-weeks Treatment of LCI699 in Patients With Cushing's Disease”
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.
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Study Primary Completion Date: December 2011
Intervention(s) in this Clinical Trial
- Drug: LCI699
Arms, Groups and Cohorts in this Clinical Trial
- Experimental: LCI699
Outcome Measures for this Clinical Trial
Primary Measures
- Change in 24 hour urine free cortisol concentration
- Time Frame: 10 weeks
Safety Issue?: No
- Time Frame: 10 weeks
Secondary Measures
- Changes in hormone levels, e.g. testosterone, estradiol
- Time Frame: 10 weeks
Safety Issue?: No
- Time Frame: 10 weeks
- Changes in metabolic abnormalities, e.g. insulin, Hemoglobin A1C (HbA1C)
- Time Frame: 10 weeks
Safety Issue?: No
- Time Frame: 10 weeks
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Patients with confirmed Cushing's Disease with confirmation of pituitary origin of excess Adrenocorticotropic Hormone (ACTH)
- Patients on medical treatment must complete a washout period prior to baseline
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%)
- Other protocol-defined inclusion/exclusion criteria may apply
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 75 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: Novartis Pharmaceuticals Industry
Overall Clinical Trial Officials and Contacts
Novartis Pharmaceuticals Study Director Novartis Pharmaceuticals
Overall Contact: Novartis Pharmaceuticals 001-862-778-8300
Additional Information
Information obtained from ClinicalTrials.gov on April 07, 2011
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01331239
Study ID Number: CLCI699C2201
ClinicalTrials.gov Identifier: NCT01331239
Health Authority: France: Afssaps - French Health Products Safety Agency
Clinical Trials Authorship and Review
Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.
From http://clinicaltrialsfeeds.org/clinical-trials/show/NCT01331239