Effects of Metyrapone in Patients With Endogenous Cushing's Syndrome
Information source: HRA Pharma
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cushing's Syndrome
Intervention: metyrapone (Drug)
Phase: Phase 3
Status: Not yet recruiting
Sponsored by: HRA Pharma
Summary
The purpose of this prospective, international phase III/IV study is to assess the efficacy
and safety of metyrapone in patients with endogenous Cushing's syndrome during up to 36
weeks of treatment. The ability of metyrapone (250 mg capsules) to normalize urinary free
cortisol (UFC) levels will be assessed during up to 36 weeks (9 months) of treatment.
Clinical Details
Official title: Prospective, Single Arm, Open-label, Multicenter, International Study to Assess the Effects of Metyrapone in Patients With Endogenous Cushing's Syndrome During a 12-week Treatment Period Followed by an Extension Period of 24 Weeks
Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Normalization of cortisol levels (urinary free cortisol)
Detailed description:
This study will include Cushing disease patients with persistent or recurrent disease (after
pituitary surgery) or who are newly diagnosed but are unsuitable for early surgery or wish
to defer surgery. It will also include patients with ectopic ACTH syndrome (either occult,
after surgery failure, or inoperable or metastatic) and patients with Cushing's syndrome
from adrenal causes.
The ability of metyrapone to normalize urinary free cortisol levels will be assessed during
up to 36 weeks (9 months) of treatment. Patients participating in this study and who are
controlled or close to the target at the end of a 3-months period may continue with an
optional extension period of 6 months in which the long-term efficacy and safety profiles of
metyrapone will be assessed. This extension study is intended to provide new findings to
consolidate existing efficacy and safety data on metyrapone in the treatment of Cushing's
syndrome.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Patients with endogenous Cushing's syndrome:
- Cushing disease patients with persistent or recurrent disease (after pituitary
surgery) or who are newly diagnosed but are unsuitable for early surgery or wish to
defer surgery;
- Patients with ectopic ACTH syndrome (either occult, after surgery failure, or
inoperable or metastatic);
- Patients with Cushing's syndrome from adrenal causes
Exclusion Criteria:
1. Pseudo Cushing's syndrome
2. Cyclic Cushing's syndrome defined by at least one normal UFC value among at least
three 24-hour urinary sampling measurements over the previous 2 months
3. Advanced adrenocortical carcinoma or ectopic ACTH secretion (EAS) secondary to a
small cell lung carcinoma
4. Life expectancy less than 3 months
5. Pituitary or adrenal surgery or pituitary irradiation or surgery of the
ACTH-secreting ectopic tumor or bilateral adrenalectomy planned before the week 12
visit
6. Pituitary irradiation within the previous 5 years (for Cushing's disease patients)
7. Enlarged pituitary adenoma (greater than 1 cm in vertical diameter and leaving less
than 2 mm from the chiasma) or compression of the optic chiasma on the pituitary MRI
for patients with Cushing's disease
8. Severe uncontrolled hypertension (>180/110 mmHg) despite anti-hypertensive therapy
(for otherwise eligible patients, blood pressure medication may be adjusted to meet
this criterion)
9. Severe hypokalemia (< 2. 5 mmol/L) despite corrective measures
10. White blood cell counts <3 x 109 /L; hemoglobin <10 g/dL; platelets <100 x 109 /L
11. Any other severe acute or chronic medical or psychiatric condition, or laboratory
abnormality that in the judgment of the investigator, would present excess risk
associated with study participation or study drug administration, or which, in the
judgment of the investigator, would make the patient inappropriate for entry into
this study.
Locations and Contacts
Additional Information
Starting date: January 2015
Last updated: November 19, 2014
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