TriangleNCT01371565 · REGISTRY CONDITION SEARCH
Compassionate Use of CORLUX® (Mifepristone) in the Treatment of Signs and Symptoms of Endogenous Cushing's Syndrome
Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.
- Phase
- PHASE3
- Status at capture
- COMPLETED
- Registry last update
- 2014-03-18
This is a compassionate use study. In addition to providing compassionate use access to mifepristone, objectives of the study will be to evaluate the safety and utility of mifepristone in the treatment of the signs and symptoms of endogenous Cushing's syndrome when given on a compassionate use basis. The study will only enroll subjects whose physicians have determined that medical treatment is needed to control the symptoms or signs of hypercortisolemia.
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
Who could take part
- eligibility Criteria
- Inclusion Criteria: 1. Have a confirmed diagnosis of endogenous hypercortisolemia caused by ACTH dependent or ACTH independent etiologies including: * Cushing's Disease that (more than one may apply) * has recurred after primary pituitary surgery * has persisted despite pituitary surgery (failed pituitary surgery) * has been treated with radiation therapy to the pituitary * is not treatable with surgery * exists in subjects who are not candidates for or who refuse surgery * Ectopic ACTH * Ectopic CRF secretion * Adrenal adenoma * Adrenal carcinoma * Adrenal autonomy 2. Have documented biochemical evidence of endogenous hypercortisolemia which includes elevated urinary free cortisol. 3. Require medical treatment of hypercortisolemia. Exclusion Criteria: Individuals not eligible to be enrolled into the study are those who: * Have de novo Cushing's disease and are surgical candidates for pituitary surgery. * Have an acute or unstable medical problem, which could be aggravated by mifepristone treatment. * Taking medications within 14 days of the baseline visit (Day 1) that a) have a large first pass metabolism largely mediated by CYP3A4 and a narrow therapeutic margin and/or b) are strong CYP3A4 inhibitors. * Female patients of reproductive potential, who are pregnant or who are unable or unwilling to use medically acceptable, non-hormonal methods of contraception during the study. * Have received investigational treatment (drug, biological agent or device) within 30 days of Screening * Have a history of an allergic reaction or intolerance to CORLUX (mifepristone) * Have a non-endogenous source of hypercortisolemia such as factious hypercortisolemia (exogenous source of glucocorticoid, iatrogenic Cushing's syndrome), factious or therapeutic use of ACTH * Have Pseudo-Cushing's syndrome. * Postmenopausal women with an intact uterus who have experienced unexplained vaginal bleeding within 12 months of Screening are excluded.
- healthy Volunteers
- false
- minimum Age
- 18 Years
- sex
- ALL
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- intervention Names
- Drug: Mifepristone
- label
- mifepristone
- type
- EXPERIMENTAL
- interventions
- arm Group Labels
- mifepristone
- description
- mifepristone at doses from 300mg/day up to 1200mg/day
- name
- Mifepristone
- other Names
- CORLUX®
- type
- DRUG
Study design
- allocation
- NA
- intervention Model
- SINGLE_GROUP
- masking Info
- masking
- NONE
- primary Purpose
- TREATMENT
Enrollment
- count
- 4
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- description
- Safety was assessed at all visits and adverse events were recorded.
- measure
- Number of Participants With Adverse Events
- time Frame
- 6 months
Full study description
- brief Summary
- This is a compassionate use study. In addition to providing compassionate use access to mifepristone, objectives of the study will be to evaluate the safety and utility of mifepristone in the treatment of the signs and symptoms of endogenous Cushing's syndrome when given on a compassionate use basis. The study will only enroll subjects whose physicians have determined that medical treatment is needed to control the symptoms or signs of hypercortisolemia.
Source references
Source notices and limitations
Discovery and provenance
- release id
- ctgov-registry-1336d216cbd1bbff780dac70
- edge id
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- payload
- clinical indication matching status
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- end exclusive
- true
- id
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- link basis
- returned_by_explicit_condition_and_posted_results_filter_query
- nct id
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- occurrences
- context exact
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- end
- 11
- exact text
- NCT01371565
- start
- 0
- offset unit
- unicode_code_points
- query cond
- Pituitary Tumors
- query disease state id
- ds-pituitary-tumors
- source file
- /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-pituitary-tumors-000.json
- source file sha256
- 3ef78ce4ecba793eb2b9932bd51babe9d6d7cee15aba0d82d9e98002353b720a
- source json pointer
- /studies/0/protocolSection/identificationModule/nctId
- source kind
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- source record id
- Source null
- source string basis
- parsed_JSON_string_unmodified
- source string sha256
- a04afa0e2e28670e76b987c2470a68d959a87ecbf997be3e0526b0d924c2ef57
Preserved source evidence · Not medical advice