Trial Outcomes & Findings for An Extension Study of CORLUX in the Treatment of Endogenous Cushing's Syndrome (NCT NCT00936741)
NCT ID: NCT00936741
Last Updated: 2014-04-02
Results Overview
Subjects who received at least one dose of mifepristone were included in the safety analysis.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
30 participants
Primary outcome timeframe
Up to three years.
Results posted on
2014-04-02
Participant Flow
Subjects completing 24 weeks of mifepristone treatment under Corcept protocol C1073-400 (NCT00569582) were eligible to continue treatment in C1073-415 at the dose being administered at the end of treatment in C1073-400 (NCT00569582).
Only subjects who had completed C1073-400 (NCT00569582) were enrolled. All subjects received active drug (no placebo).
Participant milestones
| Measure |
Open-label
mifepristone at doses from 300 mg/day up to 1200 mg/day daily
|
|---|---|
|
Overall Study
STARTED
|
30
|
|
Overall Study
COMPLETED
|
21
|
|
Overall Study
NOT COMPLETED
|
9
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
An Extension Study of CORLUX in the Treatment of Endogenous Cushing's Syndrome
Baseline characteristics by cohort
| Measure |
Open-label
n=30 Participants
mifepristone at doses from 300 mg/day up to 1200 mg/day daily
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
27 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
|
Age, Continuous
|
46.1 years
STANDARD_DEVIATION 11.74 • n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to three years.Population: Subjects who received one dose of study drug were included in the safety and ITT analyses.
Subjects who received at least one dose of mifepristone were included in the safety analysis.
Outcome measures
| Measure |
Open-label
n=30 Participants
mifepristone at doses from 300 mg/day up to 1200 mg/day daily
|
|---|---|
|
Number of Participants With Adverse Events
|
30 participants
|
SECONDARY outcome
Timeframe: Up to three years.The mean Investigator's rating of the change in subject's signs and symptoms of Cushing's syndrome from Baseline (Entry into C1073-415) to Endpoint on the Physician's Global Assessment of Disease Severity was ranked on a 9-point scale (9 = much worse, 7 = worse, 5 = no change, 3 = better, 1 = much better). Higher scores indicate more severe illness. Scoring was done at all visits except the 6 Week Follow-up visit; the final visit result (Endpoint) is reported here. The instruction was "Rate the change in the subject's signs and symptoms of Cushing's from Baseline (1 = much better to 9 = much worse)".
Outcome measures
| Measure |
Open-label
n=30 Participants
mifepristone at doses from 300 mg/day up to 1200 mg/day daily
|
|---|---|
|
The Long-term Benefit of Mifepristone Treatment in Cushing's Syndrome as Measured by Changes in the Score on the Physician's Global Assessment of Disease Severity
|
3.3 units on a scale
Standard Deviation 1.74
|
Adverse Events
Mifepristone 300 to 1200 mg Daily
Serious events: 18 serious events
Other events: 30 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Mifepristone 300 to 1200 mg Daily
n=30 participants at risk
mifepristone at doses from 300 mg/day to 1200 mg/day
|
|---|---|
|
Cardiac disorders
Pericarditis
|
3.3%
1/30 • Number of events 1 • up to 36 months from entry.
|
|
Endocrine disorders
Adrenal Insufficiency
|
6.7%
2/30 • Number of events 2 • up to 36 months from entry.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
3.3%
1/30 • Number of events 1 • up to 36 months from entry.
|
|
Immune system disorders
Amyloidosis
|
3.3%
1/30 • Number of events 1 • up to 36 months from entry.
|
|
Infections and infestations
Pneumonia
|
6.7%
2/30 • Number of events 2 • up to 36 months from entry.
|
|
Infections and infestations
Arthritis Bacterial
|
3.3%
1/30 • Number of events 1 • up to 36 months from entry.
|
|
Infections and infestations
Gastroenteritis
|
3.3%
1/30 • Number of events 1 • up to 36 months from entry.
|
|
Infections and infestations
Groin abscess
|
3.3%
1/30 • Number of events 1 • up to 36 months from entry.
|
|
Infections and infestations
Subcutaneous abscess
|
3.3%
1/30 • Number of events 1 • up to 36 months from entry.
|
|
Injury, poisoning and procedural complications
Hip Fracture
|
3.3%
1/30 • Number of events 1 • up to 36 months from entry.
|
|
Investigations
Blood Postassium Decreased
|
13.3%
4/30 • Number of events 4 • up to 36 months from entry.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
3.3%
1/30 • Number of events 1 • up to 36 months from entry.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
3.3%
1/30 • Number of events 1 • up to 36 months from entry.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
|
3.3%
1/30 • Number of events 1 • up to 36 months from entry.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma in situ
|
3.3%
1/30 • Number of events 1 • up to 36 months from entry.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
3.3%
1/30 • Number of events 1 • up to 36 months from entry.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
3.3%
1/30 • Number of events 1 • up to 36 months from entry.
|
|
Nervous system disorders
Amnesia
|
3.3%
1/30 • Number of events 1 • up to 36 months from entry.
|
|
Nervous system disorders
Cerebral infarction
|
3.3%
1/30 • Number of events 1 • up to 36 months from entry.
|
|
Nervous system disorders
Cerebrovascular accident
|
3.3%
1/30 • Number of events 1 • up to 36 months from entry.
|
|
Psychiatric disorders
Anxiety
|
3.3%
1/30 • Number of events 1 • up to 36 months from entry.
|
|
Renal and urinary disorders
Nephrolithiasis
|
3.3%
1/30 • Number of events 1 • up to 36 months from entry.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
3.3%
1/30 • Number of events 1 • up to 36 months from entry.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.3%
1/30 • Number of events 1 • up to 36 months from entry.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
3.3%
1/30 • Number of events 1 • up to 36 months from entry.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
3.3%
1/30 • Number of events 1 • up to 36 months from entry.
|
|
Vascular disorders
Hypertensive crisis
|
3.3%
1/30 • Number of events 1 • up to 36 months from entry.
|
Other adverse events
| Measure |
Mifepristone 300 to 1200 mg Daily
n=30 participants at risk
mifepristone at doses from 300 mg/day to 1200 mg/day
|
|---|---|
|
Endocrine disorders
Adrenal insufficiency
|
10.0%
3/30 • Number of events 3 • up to 36 months from entry.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
16.7%
5/30 • Number of events 6 • up to 36 months from entry.
|
|
Gastrointestinal disorders
Nausea
|
50.0%
15/30 • Number of events 29 • up to 36 months from entry.
|
|
Gastrointestinal disorders
Vomiting
|
23.3%
7/30 • Number of events 14 • up to 36 months from entry.
|
|
General disorders
Fatique
|
40.0%
12/30 • Number of events 14 • up to 36 months from entry.
|
|
General disorders
Oedema peripheral
|
23.3%
7/30 • Number of events 10 • up to 36 months from entry.
|
|
Infections and infestations
Nasopharyngitis
|
20.0%
6/30 • Number of events 7 • up to 36 months from entry.
|
|
Infections and infestations
Upper respiratory tract infection
|
20.0%
6/30 • Number of events 7 • up to 36 months from entry.
|
|
Investigations
Blood potassium decreased
|
46.7%
14/30 • Number of events 46 • up to 36 months from entry.
|
|
Investigations
Thyroid function test abnormal
|
20.0%
6/30 • Number of events 6 • up to 36 months from entry.
|
|
Nervous system disorders
Headache
|
36.7%
11/30 • Number of events 22 • up to 36 months from entry.
|
|
Nervous system disorders
Dizziness
|
23.3%
7/30 • Number of events 9 • up to 36 months from entry.
|
|
Blood and lymphatic system disorders
Anaemia
|
6.7%
2/30 • Number of events 2 • up to 36 months from entry.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
6.7%
2/30 • Number of events 2 • up to 36 months from entry.
|
|
Cardiac disorders
Atrioventricular block first degree
|
6.7%
2/30 • Number of events 2 • up to 36 months from entry.
|
|
Cardiac disorders
Sinus bradycardia
|
13.3%
4/30 • Number of events 6 • up to 36 months from entry.
|
|
Cardiac disorders
Tachycadia
|
10.0%
3/30 • Number of events 3 • up to 36 months from entry.
|
|
Endocrine disorders
Cushing's syndrome
|
6.7%
2/30 • Number of events 2 • up to 36 months from entry.
|
|
Endocrine disorders
Gynaecomastia
|
10.0%
3/30 • Number of events 3 • up to 36 months from entry.
|
|
Endocrine disorders
Hypothyroidism
|
10.0%
3/30 • Number of events 3 • up to 36 months from entry.
|
|
Eye disorders
Cataract nuclear
|
6.7%
2/30 • Number of events 3 • up to 36 months from entry.
|
|
Eye disorders
Diplopia
|
6.7%
2/30 • Number of events 2 • up to 36 months from entry.
|
|
Eye disorders
Vision blurred
|
6.7%
2/30 • Number of events 3 • up to 36 months from entry.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
6.7%
2/30 • Number of events 2 • up to 36 months from entry.
|
|
Gastrointestinal disorders
Abdominal distension
|
6.7%
2/30 • Number of events 2 • up to 36 months from entry.
|
|
Gastrointestinal disorders
Abdominal pain
|
10.0%
3/30 • Number of events 3 • up to 36 months from entry.
|
|
Gastrointestinal disorders
Constipation
|
10.0%
3/30 • Number of events 3 • up to 36 months from entry.
|
|
Gastrointestinal disorders
Diarrhoea
|
10.0%
3/30 • Number of events 4 • up to 36 months from entry.
|
|
Gastrointestinal disorders
Toothache
|
6.7%
2/30 • Number of events 2 • up to 36 months from entry.
|
|
General disorders
Chest pain
|
6.7%
2/30 • Number of events 4 • up to 36 months from entry.
|
|
Infections and infestations
Pneumonia
|
10.0%
3/30 • Number of events 3 • up to 36 months from entry.
|
|
Infections and infestations
Sinusitis
|
6.7%
2/30 • Number of events 2 • up to 36 months from entry.
|
|
Infections and infestations
Urinary tract infection
|
13.3%
4/30 • Number of events 7 • up to 36 months from entry.
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
10.0%
3/30 • Number of events 3 • up to 36 months from entry.
|
|
Injury, poisoning and procedural complications
Contusion
|
10.0%
3/30 • Number of events 3 • up to 36 months from entry.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
6.7%
2/30 • Number of events 2 • up to 36 months from entry.
|
|
Investigations
Androgens increased
|
6.7%
2/30 • Number of events 3 • up to 36 months from entry.
|
|
Investigations
Blood cholesterol increased
|
13.3%
4/30 • Number of events 4 • up to 36 months from entry.
|
|
Investigations
Blood corticotrophin increased
|
6.7%
2/30 • Number of events 2 • up to 36 months from entry.
|
|
Investigations
Blood creatinine increased
|
6.7%
2/30 • Number of events 2 • up to 36 months from entry.
|
|
Investigations
Blood potassium increased
|
6.7%
2/30 • Number of events 3 • up to 36 months from entry.
|
|
Investigations
Blood testosterone free increased
|
10.0%
3/30 • Number of events 4 • up to 36 months from entry.
|
|
Investigations
Blood testosterone increased
|
10.0%
3/30 • Number of events 3 • up to 36 months from entry.
|
|
Investigations
Electrocardiogram QT prolonged
|
10.0%
3/30 • Number of events 3 • up to 36 months from entry.
|
|
Investigations
Protein urine
|
6.7%
2/30 • Number of events 2 • up to 36 months from entry.
|
|
Investigations
Urine cortisol / creatinine ratio increased
|
6.7%
2/30 • Number of events 3 • up to 36 months from entry.
|
|
Investigations
White blood cell count increased
|
6.7%
2/30 • Number of events 2 • up to 36 months from entry.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
10.0%
3/30 • Number of events 4 • up to 36 months from entry.
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
6.7%
2/30 • Number of events 2 • up to 36 months from entry.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
10.0%
3/30 • Number of events 4 • up to 36 months from entry.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
6.7%
2/30 • Number of events 2 • up to 36 months from entry.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.7%
2/30 • Number of events 3 • up to 36 months from entry.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.7%
5/30 • Number of events 5 • up to 36 months from entry.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
6.7%
2/30 • Number of events 3 • up to 36 months from entry.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
10.0%
3/30 • Number of events 4 • up to 36 months from entry.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
6.7%
2/30 • Number of events 5 • up to 36 months from entry.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
13.3%
4/30 • Number of events 5 • up to 36 months from entry.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.7%
2/30 • Number of events 2 • up to 36 months from entry.
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
6.7%
2/30 • Number of events 2 • up to 36 months from entry.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
6.7%
2/30 • Number of events 2 • up to 36 months from entry.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pituitary tumor benign
|
10.0%
3/30 • Number of events 4 • up to 36 months from entry.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
6.7%
2/30 • Number of events 2 • up to 36 months from entry.
|
|
Nervous system disorders
Muscular weakness
|
6.7%
2/30 • Number of events 3 • up to 36 months from entry.
|
|
Psychiatric disorders
Anxiety
|
10.0%
3/30 • Number of events 3 • up to 36 months from entry.
|
|
Psychiatric disorders
Depression
|
10.0%
3/30 • Number of events 5 • up to 36 months from entry.
|
|
Psychiatric disorders
Insomnia
|
13.3%
4/30 • Number of events 4 • up to 36 months from entry.
|
|
Psychiatric disorders
Panic attack
|
6.7%
2/30 • Number of events 2 • up to 36 months from entry.
|
|
Psychiatric disorders
Sleep disorder
|
6.7%
2/30 • Number of events 3 • up to 36 months from entry.
|
|
Renal and urinary disorders
Nephrolithiasis
|
10.0%
3/30 • Number of events 3 • up to 36 months from entry.
|
|
Renal and urinary disorders
Pollakiuria
|
6.7%
2/30 • Number of events 2 • up to 36 months from entry.
|
|
Reproductive system and breast disorders
Endometrial disorder
|
13.3%
4/30 • Number of events 7 • up to 36 months from entry.
|
|
Reproductive system and breast disorders
Endometrial hypertrophy
|
33.3%
10/30 • Number of events 12 • up to 36 months from entry.
|
|
Reproductive system and breast disorders
Metrorrhagia
|
13.3%
4/30 • Number of events 5 • up to 36 months from entry.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
6.7%
2/30 • Number of events 4 • up to 36 months from entry.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
13.3%
4/30 • Number of events 8 • up to 36 months from entry.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.0%
3/30 • Number of events 4 • up to 36 months from entry.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
6.7%
2/30 • Number of events 4 • up to 36 months from entry.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
6.7%
2/30 • Number of events 3 • up to 36 months from entry.
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
6.7%
2/30 • Number of events 2 • up to 36 months from entry.
|
|
Vascular disorders
Hot flush
|
6.7%
2/30 • Number of events 2 • up to 36 months from entry.
|
|
Vascular disorders
Hypertension
|
30.0%
9/30 • Number of events 14 • up to 36 months from entry.
|
|
Vascular disorders
Hypotension
|
6.7%
2/30 • Number of events 3 • up to 36 months from entry.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60