Resumen

El propósito de este estudio es permitir el uso continuado de pasireotida en pacientes que están en tratamiento con pasireotida en un estudio patrocinado por Novartis y que se benefician del tratamiento según el criterio del investigador.

Descripción detallada

Este es un estudio de fase IV, multicéntrico, abierto, para proporcionar suministro continuo de pasireotida a pacientes en tratamiento en un estudio actual patrocinado por Novartis y que se benefician del tratamiento con pasireotida sola o en combinación con otro tratamiento para la enfermedad de Cushing y la acromegalia. Los pacientes elegibles darán su consentimiento y podrán continuar el tratamiento con pasireotida sola o en combinación con otro tratamiento para la enfermedad de Cushing y la acromegalia en este protocolo. Todos los pacientes en sus visitas programadas tendrán información de dispensación de fármacos y eventos adversos y eventos adversos graves reportados recopilados. Un paciente alcanzará el final del estudio cuando el tratamiento con pasireotida se suspenda de forma permanente y se haya realizado la visita de fin de tratamiento. Todos los pacientes deben ser seguidos para evaluaciones de seguridad durante 3 meses después de la última dosis del tratamiento con pasireotida LAR y durante 1 mes después de la última dosis del tratamiento con pasireotida s.c. Se espera que el estudio permanezca abierto durante aproximadamente 10 años o hasta que los pacientes inscriptos ya no necesiten tratamiento con pasireotida o puedan obtener suministro comercial según las regulaciones locales para su condición médica.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Patient is currently participating in a Novartis-sponsored study receiving pasireotide (LAR and/or s.c.) on monotherapy or combination therapy (for Cushing's Disease or Acromegaly), and has fulfilled all required assessments in the parent study and patients that are benefiting from the study treatment have no other alternatives.
Patient is currently benefiting from the treatment with pasireotide, as determined by the investigator
Patient has demonstrated compliance, as assessed by the investigator, with the parent study requirements.
Willingness and ability to comply with scheduled visits, treatment plans and any other study procedures.
Written informed consent obtained prior to enrolling in roll-over study and receiving study medication.
If consent cannot be expressed in writing, it must be formally documented and witnessed, ideally via an independent trusted witness.

Criterios de exclusión

Patient has been permanently discontinued from pasireotide study treatment in the parent study due to unacceptable toxicity, non-compliance to study procedures, withdrawal of consent or any other reason.
Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test.
Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during the study treatment and for 30 days after the final dose of pasireotide s.c. and 84 days after the final dose of pasireotide LAR. Highly effective contraception is defined as either:
Total abstinence (when this is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception
Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy) or tubal ligation at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment.
Male sterilization (at least 6 months prior to enrolling). For female patients on the study the vasectomized male partner should be the sole partner for that patient.
Use of oral, injected or implanted hormonal methods of contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS), or other forms of hormonal contraception that have comparable efficacy (failure rate \<1%), for example hormone vaginal ring or transdermal hormone contraception.
In case of use of oral contraception women should have been stable on the same pill for a minimum of 3 months before taking study treatment.
Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (i.e. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy), total hysterectomy, or tubal ligation at least six weeks ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child-bearing potential.
Sexually active males, unless they use a condom during intercourse while taking drug and for 1 months after pasireotide s.c. last dose and 3 months after pasireotide LAR last dose, 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

Administered subcutaneously in strengths 0.3mg, 0.6mg and 0.9mg. Doses to be taken BID or TID, dependent on parent study guidelines.

drug

Cabergoline

Cabergoline tablet 0.5mg or 1.0mg taken by mouth once daily may be combined with subcutaneous formulation of pasireotide for Cushing's Disease or Acromegaly. Dose is dependent on parent study guidelines.

drug

Pasireotide LAR

Long Acting Release is administered by a single intramuscular (i.m.) monthly injection. The strengths are 10mg, 20mg, 40mg and 60mg. All doses to be taken q28days. Strength is dependent on parent study guidelines.

Protocolo de extensión de pasireotida abierto, multicéntrico, para pacientes que hayan completado un estudio previo de pasireotida patrocinado por Novartis y que, en opinión del investigador, se beneficien de continuar el tratamiento con pasireotida

Resumen

Descripción detallada

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

Pasireotide

Cabergoline

Pasireotide LAR

Ubicaciones

Recordati Investigative Site

Recordati Investigative Site

Patrocinadores