Roll-over Study in Patients With Endogenous Cushing's Syndrome for LCI699

An Open-label, Multi-center, Roll-over Study to Assess Long Term Safety in Patients With Endogenous Cushing's Syndrome Who Have Completed a Prior Novartis-sponsored Osilodrostat (LCI699) Study and Are Judged by the Investigator to Benefit From Continued Treatment With Osilodrostat

ClinicalTrials.gov Identifier: NCT03606408

Novartis Reference Number: CLCI699C2X01B

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

The purpose of this study is the evaluation of long-term safety of osilodrostat in patients who have already received osilodrostat treatment in a previous Global Novartis-sponsored trial and who, based on investigators' judgement, will continue benefiting with its administration.

Condition 
Cushing's Syndrome
Phase 
Phase 2
Overall status 
Recruiting
Enrollment count 
180 participants
Start date 
Oct 05, 2018
Completion date 
Sep 27, 2023
Gender 
All
Age(s)
18 Years - 75 Years (Adult, Older Adult)

Interventions

Drug
osilodrostat
osilodrostat, in the form of film coated tablets for oral administration, in the following tablet strengths: 1mg, 5mg, 10mg. Each strength has unique tablet size, colour and imprint.

Eligibility Criteria

Inclusion Criteria:

Patient is currently participating in a Global Novartis-sponsored study receiving osilodrostat for any type of endogenous CS and has fulfilled all their requirements in the parent study.
Patient is currently benefiting from treatment with osilodrostat, as determined by the Investigator.
Patient has demonstrated compliance, as assessed by the Investigator, with the parent study protocol requirements.
Willingness and ability to comply with scheduled visits and treatment plans.
Written informed consent obtained prior to enrolling into the roll-over study before evaluating the applicability of the subject's participating in the study. -- If consent cannot be expressed in writing, it must be formally documented and witnessed, ideally via an independent trusted witness.

Exclusion Criteria:

Patient has been permanently discontinued from osilodrostat study treatment in a parent Novartis-sponsor study.
Patients who are receiving osilodrostat in combination with unapproved or experimental treatments for any type of endogenous CS.
Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test. Pregnant or nursing (lactating) women

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 of study after stopping medication. Highly effective contraception methods include:

Total abstinence (when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception
Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy, or tubal ligation. at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment
Male sterilization (at least 6 months prior to baseline). The vasectomized male partner should be the sole partner for that subject
Use of oral, (estrogen and progesterone), injected or implanted hormonal methods of contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS), or other forms of hormonal contraception that have comparable efficacy (failure rate <1%), for example hormone vaginal ring or transdermal hormone contraception.

Study Locations

United States
University of Colorado
Recruiting
Aurora, 80045
Colorado
United States
Emory University School of Medicine G2304 - C2301
Recruiting
Atlanta, 30322
Georgia
United States
Northwestern University SC - LCI699C2301
Recruiting
Chicago, 60611
Illinois
United States
University of Michigan Comprehensive Cancer Center
Recruiting
Ann Arbor, 48109
Michigan
United States
Columbia University Medical Center New York Presbyterian Neuroendocrine Unit
Recruiting
New York, 10032
New York
United States
Memorial Sloan Kettering Cancer Center
Recruiting
New York, 10065
New York
United States
Cleveland Clinic Foundation
Recruiting
Cleveland, 44195
Ohio
United States
Oregon Health and Science University
Recruiting
Portland, 97239
Oregon
United States
University of Pennsylvania Medical Center Univ Penn
Recruiting
Philadelphia, 19104
Pennsylvania
United States
Medical College of Wisconsin MCW 2
Recruiting
Milwaukee, 53226
Wisconsin
United States
Argentina
Novartis Investigative Site
Recruiting
Caba, C1180AAX
Buenos Aires
Argentina
Austria
Novartis Investigative Site
Active, not recruiting
Vienna, A-1090
-
Austria
Belgium
Novartis Investigative Site
Recruiting
Leuven, 3000
-
Belgium
Brazil
Novartis Investigative Site
Recruiting
Fortaleza, 60020-181
CE
Brazil
Novartis Investigative Site
Recruiting
Rio de Janeiro, 21941-913
RJ
Brazil
Novartis Investigative Site
Recruiting
Sao Paulo, 04039 004
SP
Brazil
Novartis Investigative Site
Recruiting
Sao Paulo, 05403 000
SP
Brazil
Bulgaria
Novartis Investigative Site
Recruiting
Sofia, 1431
-
Bulgaria
Canada
Novartis Investigative Site
Active, not recruiting
Edmonton, T6G 2B7
Alberta
Canada
Novartis Investigative Site
Recruiting
Halifax, B3H 1V7
Nova Scotia
Canada
Novartis Investigative Site
Active, not recruiting
Montreal, H2W 1T8
Quebec
Canada
Novartis Investigative Site
Recruiting
Sherbrooke, J1H 5N4
Quebec
Canada
China
Novartis Investigative Site
Recruiting
Chengdu, 610041
Sichuan
China
Novartis Investigative Site
Recruiting
Beijing, 100034
-
China
Novartis Investigative Site
Recruiting
Beijing, 100730
-
China
Costa Rica
Novartis Investigative Site
Recruiting
San Pedro, 1406 1200
San Jose, Costa Rica
Costa Rica
France
Novartis Investigative Site
Active, not recruiting
Pessac, 33604
Cedex
France
Novartis Investigative Site
Active, not recruiting
Le Kremlin Bicetre, 94275
-
France
Novartis Investigative Site
Active, not recruiting
Lille Cedex, 59037
-
France
Novartis Investigative Site
Active, not recruiting
Paris, 75014
-
France
Germany
Novartis Investigative Site
Completed
Erlangen, 91054
-
Germany
Novartis Investigative Site
Active, not recruiting
Muenchen, 81377
-
Germany
India
Novartis Investigative Site
Active, not recruiting
New Delhi, 110029
-
India
Italy
Novartis Investigative Site
Recruiting
Ancona, 60126
AN
Italy
Novartis Investigative Site
Recruiting
Padova, 35128
PD
Italy
Novartis Investigative Site
Recruiting
Pisa, 56124
PI
Italy
Novartis Investigative Site
Recruiting
Napoli, 80131
-
Italy
Japan
Novartis Investigative Site
Active, not recruiting
Nagoya, 460-0001
Aichi
Japan
Novartis Investigative Site
Completed
Nishinomiya, 663 8501
Hyogo
Japan
Korea, Republic of
Novartis Investigative Site
Active, not recruiting
Seoul, 03080
-
Korea, Republic of
Novartis Investigative Site
Active, not recruiting
Seoul, 03722
-
Korea, Republic of
Poland
Novartis Investigative Site
Recruiting
Krakow, 31-501
-
Poland
Novartis Investigative Site
Active, not recruiting
Warszawa, 03 242
-
Poland
Russian Federation
Novartis Investigative Site
Recruiting
Moscow, 117036
-
Russian Federation
Spain
Novartis Investigative Site
Recruiting
Sevilla, 41013
Andalucia
Spain
Novartis Investigative Site
Recruiting
La Coruna, 15006
Galicia
Spain
Novartis Investigative Site
Active, not recruiting
Madrid, 28009
-
Spain
Novartis Investigative Site
Recruiting
Valencia, 46026
-
Spain
Thailand
Novartis Investigative Site
Recruiting
Bangkok, 10330
-
Thailand
Novartis Investigative Site
Recruiting
Bangkok, 10700
-
Thailand
Novartis Investigative Site
Recruiting
Songkla, 90110
-
Thailand
Turkey
Novartis Investigative Site
Recruiting
Istanbul, 34098
TUR
Turkey
Novartis Investigative Site
Recruiting
Altunizade, 34662
-
Turkey
Novartis Investigative Site
Recruiting
Kocaeli, 41380
-
Turkey

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
1-888-669-6682
Name: 
Novartis Pharmaceuticals
Phone: 
+41613241111
Email: 

Have a question?

Call 1-999-669-6682 or email [email protected]