Clinical trial NCT03604198: Extension Study to Evaluate the Safety of Long-Term Use of Relacorilant in Patients With Cushing Syndrome
Official title: An Open-Label Extension Study of the Safety of Relacorilant (CORT125134) in the Treatment of the Signs and Symptoms of Endogenous Cushing Syndrome
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Cushing Syndrome
Keywords: Cushing Syndrome
Cushing Disease
Cushing
Hypercortisolemia
Cushingoid
Type 2 Diabetes
Impaired Glucose Intolerance
Hypertension
Adrenal Corticotrophic Hormone (ACTH)
Adrenocortical Carcinoma
Primary Pigmented Nodular Adrenal Disease (PPNAD)
Moon Facies
Dorsocervical Fat Pad
Adrenal Adenoma
Adrenal Carcinoma
Adrenal Autonomy
Cortisol
Lead sponsor: Corcept Therapeutics
Sponsor class: INDUSTRY
First posted: 2018-07-27
Enrollment: 125
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is an open-label extension study to evaluate the long-term safety of relacorilant in patients with endogenous Cushing syndrome who successfully completed participation in a Corcept-sponsored study of relacorilant and may benefit from continuing treatment.

Detailed description: This study is designed to allow continued therapy with relacorilant, a potent, selective glucocorticoid receptor (GR) antagonist in patients who have successfully completed participation of a Corcept-sponsored study of relacorilant (referred to as the "parent" study). Patients may qualify to enter this extension study if they complete their last treatment visit in their parent study and in the Investigator's opinion will benefit from continued treatment.

Once-daily dosing with relacorilant may continue for patients who receive clinical benefits (as judged by the Investigator) until relacorilant is commercially or otherwise available or the study is stopped by the Sponsor. A patient's dose may be maintained, reduced, or increased based on individual response and tolerability.

Eligibility criteria: Inclusion Criteria:

* Major Inclusion Criteria:

  * Have completed a Corcept-sponsored study of relacorilant in endogenous Cushing syndrome with at least 80% compliance with the dosing schedule.
  * According to the Investigator's opinion will benefit from continuing treatment with relacorilant

Exclusion Criteria:

* Major Exclusion Criteria:

  * Premature discontinuation from a relacorilant parent study.
  * Has uncontrolled, clinically significant hypothyroidism or hyperthyroidism
  * Has poorly controlled hypertension
  * Has Stage ≥ 4 renal failure

Primary outcomes:
measure: Long-term safety of relacorilant
timeFrame: 36 months
Secondary outcomes:
Other outcomes:
measure: Long-term benefit of relacorilant
timeFrame: 36 months
measure: Long-term benefit of relacorilant
timeFrame: 36 months
measure: Long-term benefit of relacorilant
timeFrame: 36 months
measure: Long-term benefit of relacorilant
timeFrame: 36 months
measure: Long-term benefit of relacorilant
timeFrame: 36 months
measure: Long-term benefit of relacorilant
timeFrame: 36 months
Locations:
city: Phoenix
country: United States
facility: Site 49
state: Arizona
city: Stanford
country: United States
facility: Site 35
state: California
city: Torrance
country: United States
facility: Site 39
state: California
city: Miami
country: United States
facility: Site 50
state: Florida
city: Atlanta
country: United States
facility: Site 10
state: Georgia
city: Chicago
country: United States
facility: Site 9
state: Illinois
city: Indianapolis
country: United States
facility: Site 1
state: Indiana
city: Metairie
country: United States
facility: Site 5
state: Louisiana
city: Baltimore
country: United States
facility: Site 27
state: Maryland
city: Fall River
country: United States
facility: Site 13
state: Massachusetts
city: Ann Arbor
country: United States
facility: Site 8
state: Michigan
city: Rochester
country: United States
facility: Site 36
state: Minnesota
city: Jackson
country: United States
facility: Site 34
state: Mississippi
city: Saint Louis
country: United States
facility: Site 3
state: Missouri
city: Reno
country: United States
facility: Site 55
state: Nevada
city: Albany
country: United States
facility: Site 6
state: New York
city: New York
country: United States
facility: Site 24
state: New York
city: Wilmington
country: United States
facility: Site 4
state: North Carolina
city: Cleveland
country: United States
facility: Site 43
state: Ohio
city: Oklahoma City
country: United States
facility: Site 41
state: Oklahoma
city: Pittsburgh
country: United States
facility: Site 2
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Site 46
state: Pennsylvania
city: Dallas
country: United States
facility: Site 11
state: Texas
city: El Paso
country: United States
facility: Site 7
state: Texas
city: Fort Worth
country: United States
facility: Site 32
state: Texas
city: Houston
country: United States
facility: Site 12
state: Texas
city: Wien
country: Austria
facility: Site 14
city: Nova Scotia
country: Canada
facility: Site 51
city: Munich
country: Germany
facility: Site 16
city: Wuerzburg
country: Germany
facility: Site 42
city: Ramat Gan
country: Israel
facility: Site 20
city: Tel Aviv
country: Israel
facility: Site 29
city: Ancona
country: Italy
facility: Site 40
city: Messina
country: Italy
facility: Site 44
city: Milano
country: Italy
facility: Site 25
city: Napoli
country: Italy
facility: Site 21
city: Padova
country: Italy
facility: Site 48
city: Torino
country: Italy
facility: Site 52
city: Rotterdam
country: Netherlands
facility: Site 33
city: Kraków
country: Poland
facility: Site 47
city: Lublin
country: Poland
facility: Site 45
city: Bucharest
country: Romania
facility: Site 28
city: Bucuresti
country: Romania
facility: Site 37
city: Bucuresti
country: Romania
facility: Site 31
city: Alicante
country: Spain
facility: Site 53
city: Girona
country: Spain
facility: Site 18
city: Madrid
country: Spain
facility: Site 17
city: Málaga
country: Spain
facility: Site 38
city: Sevilla
country: Spain
facility: Site 19
Study officials:
affiliation: Corcept Therapeutics
name: Katherine Araque, MD, MSCR
role: STUDY_DIRECTOR
References: