A trial with Metyrapone in Cushing's syndrome

• Register: EUCTR
• Last refreshed on: 7 April 2015
• Main ID: EUCTR2013-002063-26-IT
• Date of registration: 23/07/2013
• Prospective Registration: Yes
• Primary sponsor: S.C.D.U. MEDICINA INTERNA 1 Ospedale San Luigi Orbassano
• Public title: A trial with Metyrapone in Cushing's syndrome
• Scientific title: A prospective open-label Phase 2 study of METYRAPONE as a preoperative treatment in patients with ACTH-independent Cushing’s syndrome due to adrenal adenoma. - METYX01
• Date of first enrolment: 08/09/2013
• Target sample size: 15
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-002063-26
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no

Countries of recruitment

Italy

Contacts

• Name: Study Coordinator
• Affiliation: S.C.D.U. MEDICINA INTERNA 1 Ospedale San Luigi Orbassano

• Name: Study Coordinator
• Affiliation: S.C.D.U. MEDICINA INTERNA 1 Ospedale San Luigi Orbassano

Key inclusion & exclusion criteria

Inclusion criteria:
Both sexes and age= 18 years

- Confirmed diagnosis of ACTH-independent Cushing’s syndrome validated by all the following criteria:
• two 24 h urinary collections for UFC at least 1.5 times the upper normal value, within 2 weeks prior to enrollment.
• levels of serum ACTH lower than the normal range
• CT-confirmed diagnosis of adrenal adenoma (size 2-4 cm, regular shape and margins, homogeneous density <10 HU). Unenhanced adrenal CT scan should be performed within 4 weeks prior to enrollment.
• Adrenalectomy planned.


- ECOG performance status = 2

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion criteria:
Patients who meet any of the following exclusion criteria are not eligible for enrollment.

- Prior metyrapone therapy

- Mitotane therapy within 6 months prior entering the study (mitotane levels should be undetectable prior to enrollment)

- Cushing’s syndrome with ACTH levels that are not clearly suppressed

- Hypercortisolism due to an adrenal tumor of uncertain dignity (suspicious for malignancy)



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Hormonal diseases [C19]

Cushing's syndrome

Intervention(s)

Trade Name: Matyrapone
Product Name: Metyrapone
Product Code: Metyrapone
Pharmaceutical Form: Capsule, soft

Primary Outcome(s)

Main Objective: The primary objective of this study is to assess the efficacy of METYRAPONE in attaining normalization of 24-h urinary free cortisol (UFC) excretion or a =50% decrease from baseline using the mean of 2 UFC measurements within 3 months of treatment.

Primary end point(s): Primary
All patients will be included in the efficacy analysis. The primary efficacy variable is UFC.

Timepoint(s) of evaluation of this end point: 3 months

Secondary Objective: • time to response
• dose-response relationship
• effect of METYRAPONE on levels of serum cortisol, UFC, salivary cortisol, ACTH, 11-deoxicortisol, deoxycorticosterone, total testosterone, androstenedione, DHEA-S in terms of percent variation relative to baseline.
• improvement of the clinical signs associated to hypercortisolism (blood pressure, body mass index, waist)

Secondary Outcome(s)

Secondary end point(s): The secondary efficacy variables include other hormones (including serum and salivary cortisol levels), laboratory tests, and clinical signs and symptoms.

Timepoint(s) of evaluation of this end point: 3 months

Secondary ID(s)

METYX01

Source(s) of Monetary Support

HRA Pharma