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Safety and Efficacy of LCI699 in Cushing's Disease Patients.

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01331239
First received: April 6, 2011
Last updated: May 27, 2017
Last verified: May 2017
April 6, 2011
May 27, 2017
March 23, 2011
December 21, 2018   (Final data collection date for primary outcome measure)
Change in 24 hour urine free cortisol concentration [ Time Frame: baseline, 10 weeks ]
Change in 24 hour urine free cortisol concentration [ Time Frame: 10 weeks ]
Complete list of historical versions of study NCT01331239 on ClinicalTrials.gov Archive Site
  • Changes on steroid hormones of the HPA-axis in plasma, urine and saliva [ Time Frame: baseline, 10 weeks, 22 weeks ]
  • Changes in metabolic abnormalities, e.g. insulin, Hemoglobin A1C (HbA1C) [ Time Frame: baseline, 10 weeks, 22 weeks ]
  • Safety and tolerability of multiple doses of LCI699 [ Time Frame: baseline, 10 weeks ]
  • Change in 24 hour urine free cortisol concentration [ Time Frame: baseline, 22 weeks ]
  • Safety and tolerability of multiple doses of LCI699 [ Time Frame: baseline, 22 weeks ]
  • Changes in hormone levels, e.g. testosterone, estradiol [ Time Frame: 10 weeks ]
  • Changes in metabolic abnormalities, e.g. insulin, Hemoglobin A1C (HbA1C) [ Time Frame: 10 weeks ]
Not Provided
Not Provided
 
Safety and Efficacy of LCI699 in Cushing's Disease Patients.
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
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. A second extension will provide patients who are clinically benefitting from LCI699 an opportunity to continue to have access to the drug until LCI699 is commercially available and reimbursed or through the availability of a local access program.
Not Provided
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Cushing's Disease
Drug: LCI699
Experimental: LCI699
Ascending dose from 2mg bid or 5 mg bid, up to 30 mg bid
Intervention: Drug: LCI699
Bertagna X, Pivonello R, Fleseriu M, Zhang Y, Robinson P, Taylor A, Watson CE, Maldonado M, Hamrahian AH, Boscaro M, Biller BM. LCI699, a potent 11β-hydroxylase inhibitor, normalizes urinary cortisol in patients with Cushing's disease: results from a multicenter, proof-of-concept study. J Clin Endocrinol Metab. 2014 Apr;99(4):1375-83. doi: 10.1210/jc.2013-2117. Epub 2013 Dec 11.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
33
December 21, 2018
December 21, 2018   (Final data collection date for primary outcome measure)

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.
  • Patients who have received pituitary irradiation within five years prior to Visit 1.
  • Patients with risk factors for QTc prolongation or Torsade de Pointes.

Other protocol-defined inclusion/exclusion criteria may apply

Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
France,   Italy,   Japan,   United States
 
 
NCT01331239
CLCI699C2201
2010-022403-22 ( EudraCT Number )
No
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: Undecided
Plan Description:

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
May 2017

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