A Randomized, Double-blind, Multicenter, Phase III Study to Evaluate the Efficacy and Safety of Pasireotide LAR in Patients With Cushing's Disease

CompletadoFase 3ClinicalTrials.gov

ID: NCT01374906Tipo: INTERVENTIONALInicio: 4 de nov de 2011Fin estimado: 21 de dic de 2016

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Resumen

This is a randomized, double-blind, multicenter, phase III study to evaluate the safety and efficacy of 2 dosing regiments of Pasireotide long acting release (LAR) in patients with Cushing's disease.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Karnofsky performance status ≥ 60 (i.e. requires occasional assistance, but is able to care for most of their personal needs)
For patients on medical treatment for Cushing's disease the following washout periods must be completed before screening assessments are performed
Inhibitors of steroidogenesis (ketoconazole, metyrapone): 1 week
Pituitary directed agents: Dopamine agonists (bromocriptine, cabergoline) and PPARγ agonists (rosiglitazone or pioglitazone): 4 weeks
Octreotide LAR, Lanreotide SR and Lanreotide autogel: 14 weeks
Octreotide (immediate release formulation): 1 week

Criterios de exclusión

Patients who are considered candidates for surgical treatment at the time of study entry
Patients who have received pituitary irradiation within the last ten years prior to visit 1
Patients who have had any previous pasireotide treatment
Patients who have been treated with mitotane during the last 6 months prior to Visit 1
Diabetic patients on antihyperglycemic medications with poor glycemic control as evidenced by HbA1c \>8%
Patients with risk factors for torsade de pointes, i.e. patients with a baseline QTcF \>470 ms, hypokalemia, uncontrolled hypothyroidism, family history of long QT syndrome, or concomitant medications known to prolong QT interval
Female patients who are pregnant or lactating, or are of childbearing potential (defined as all women physiologically capable of becoming pregnant) and not practicing an effective method of contraception/birth control. Sexually active males must use a condom during intercourse while taking the drug and for 2 months after the last dose of study drug and should not father a child in this period. A condom is required to be used also by vasectomized men in order to prevent delivery of the drug via seminal fluid

Intervenciones

drug

pasireotide LAR

Pasireotide long-acting was administered as an intra-muscular depot intragluteal injection once every 28 days (±2 days). Patients were administered pasireotide long-acting 10 mg or 30 mg for four months, followed by either continuation of the starting dose, or dose up-titration (if mUFC was still \>1.5xULN unless titration was precluded by safety reasons).

drug

SOM230 LAR 30 mg

starting dose of 30 mg i.m. administered once every 28 days for 4 months, followed by dose up-titration or continuation of starting dose.

drug

SOM230 LAR 10 mg

starting does of SOM230 LAR 10 mg i.m. administered once every 28 days for 4 months, followed by dose up-titration or continuation of the starting dose.

Ubicaciones

Novartis Investigative Site

Buenos Aires, Argentina

Novartis Investigative Site

Córdoba, Argentina

Patrocinadores

PrincipalNovartis Pharmaceuticals

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