Saturday, April 9, 2011

Clinical Trial: Safety and Efficacy of LCI699 in Cushing's Disease Patients

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

Secondary Measures

  • Changes in hormone levels, e.g. testosterone, estradiol
    • Time Frame: 10 weeks
      Safety Issue?: No
  • Changes in metabolic abnormalities, e.g. insulin, Hemoglobin A1C (HbA1C)
    • Time Frame: 10 weeks
      Safety Issue?: No

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