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



Status:Recruiting
Conditions:Endocrine
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - 75
Updated:3/28/2019
Start Date:October 5, 2018
End Date:October 24, 2023
Contact:Novartis Pharmaceuticals
Email:novartis.email@novartis.com
Phone:1-888-669-6682

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Open-label Multi-center Roll-over Study to Assess Long Term Safety in Endogenous Cushing's Syndrome Patients Who Have Completed a Prior Novartis-sponsored Osilodrostat Study and the Investigator Judges to Benefit From Continued Treatment

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.


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.
We found this trial at
4
sites
New York, New York 10032
Principal Investigator: Pamela U. Freda
Phone: 212-305-4921
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1500 East Medical Center Drive
Ann Arbor, Michigan 48109
800-865-1125
Principal Investigator: Richard Auchus
Phone: 734-615-8914
University of Michigan Comprehensive Cancer Center The U-M Comprehensive Cancer Center's mission is the conquest...
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1275 York Ave
New York, New York 10021
(212) 639-2000
Principal Investigator: Eliza B. Geer
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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