Roll-over Study in Patients With Endogenous Cushing's Syndrome for LCI699 (NCT03606408) | Clinical Trial Compass
CompletedPhase 2
Roll-over Study in Patients With Endogenous Cushing's Syndrome for LCI699
United States127 participantsStarted 2018-10-05
Plain-language summary
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.
Who can participate
Age range18 Years – 75 Years
SexALL
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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 wee…
What they're measuring
1
Number of Participants With Adverse/Serious Adverse Events