Resumen

El propósito de este estudio es recopilar datos de seguridad a largo plazo en sujetos que continúan obteniendo beneficio clínico del tratamiento con enzalutamida a partir de su participación en un estudio clínico de enzalutamida patrocinado por Astellas o Medivation (es decir, estudio original) que haya completado, como mínimo, el análisis primario o el período de evaluación especificado en el estudio.

Descripción detallada

Los sujetos deben continuar con el régimen de tratamiento que recibían en el estudio anterior. Los cambios de dosis de cualquiera de las terapias previas que recibían los sujetos según el protocolo anterior están permitidos previa aprobación del monitor médico. La visita del Día 1 de este estudio debe coincidir con la última visita de tratamiento del estudio del que proviene el sujeto (≤7 días después de la última visita del estudio original). Los sujetos serán seguidos de acuerdo con el estándar de atención de la institución local y deberán acudir a la institución cada 24 semanas (±7 días) para revisar los eventos adversos (EA), recoger los medicamentos concomitantes y confirmar que no se cumplen criterios de discontinuación. En cada visita y cada 12 semanas (visita solo de PI) los sujetos deben devolver todos los fármacos del estudio dispensados y recibir más fármaco del estudio si corresponde. Todos los EA (nuevos y en curso desde el estudio del que proviene el sujeto) y los eventos adversos graves (EAG) (incluido el fallecimiento) se recopilarán desde el momento en que el sujeto firme el formulario de consentimiento hasta la visita de fin de estudio. Tras la aprobación de la comercialización en Corea del Sur, este estudio continuó como «estudio clínico poscomercialización» en ese país. En el resto de los países que participaron en este estudio, continuó como estudio clínico.

Elegibilidad

Edad mínima: 18 YearsSexo: MALE

Criterios de inclusión

Subject must currently be receiving enzalutamide for prostate cancer in a study sponsored by Astellas or Medivation and, based on the investigator's assessment, benefit from continued treatment. Subjects participating in investigator-initiated trials are not eligible.
Subject is able to continue on the treatment regimen that the subject was receiving in the prior study. If in the investigator's assessment, a change is needed to the subject's regimen (e.g., dose change in Androgen deprivation therapy (ADT) or dropping of a combination therapy) approval from a medical monitor is required prior to enrollment.
Subject is able to swallow enzalutamide capsules and comply with study requirements.
Subject and female partner who is of childbearing potential must continue to use 2 forms of birth control, of which 1 must be highly effective and 1 must be a barrier method throughout the study and for 3 months after final enzalutamide administration.
Subject agrees to avoid sperm donation during the study and for at least 3 months after final enzalutamide administration.
Subject agrees not to participate in another interventional study while on treatment.
Canada Specific:
Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written Informed Consent and privacy language as per national regulations (e.g., Health Insurance Portability and Accountability Act authorization for the United States sites) must be obtained from the subject prior to any study-related procedures.
Subject must currently be receiving enzalutamide for breast cancer in a study sponsored by Astellas or Medivation/Pfizer and based on the investigator's assessment, benefit from continued treatment. Subjects participating in investigator-initiated trials are not eligible.
Subject is able to continue on the treatment regimen that they were receiving in the prior study. If in the investigator's assessment, a change is needed to the subject's regimen (e.g., dropping of a combination therapy) approval from a medical monitor is required prior to enrollment.
Subject is able to swallow enzalutamide capsules and comply with study requirements.
Subject is either:
Of nonchildbearing potential:
postmenopausal (defined as no spontaneous menses for at least 12 months prior to Day 1 with follicle stimulating hormone (FSH) \> 40 IU/L at Day 1 for women \< 55 years of age),
documented surgically sterile or status post hysterectomy (at least 1 month prior to Day 1),
Or, if of childbearing potential,
must have a negative urine pregnancy test at Day 1 before the first dose of study drug is administered,
must use 2 acceptable methods of birth control starting at Day 1 and through 6 months after the final study drug administration,
must not donate ova starting at first administration of study intervention and throughout 6 months after final study intervention administration.
The 2 acceptable methods of birth control are as follows or per local guidelines where these require additional description of contraceptive methods:
A barrier method (e.g., condom by a male partner) is required; AND
One of the following is required:
Placement of an intrauterine device (IUD) or intrauterine system (IUS);
Additional barrier method including occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository;
Vasectomy or other surgical castration at least 6 months before Day 1.
The subject must not be breastfeeding at Day 1 or during the study period, and for 6 months after the final study drug administration.
Subject agrees not to participate in another interventional study while on treatment.

Criterios de exclusión

Subject met any of the discontinuation criteria or whose cancer progressed on the current enzalutamide clinical study in which subject is enrolling from.
Subject requires treatment with or plans to use either of the following:
New systemic therapy for subjects cancer (palliative radiation therapy is allowed). The treatment with agents administered during previous studies which was stopped and then restarted during this study does not represent new treatment.
Investigational therapy other than enzalutamide.
Subject is currently participating in an investigator-initiated interventional trial and receiving enzalutamide.
Subject has any concurrent disease, infection, or comorbid condition that interferes with the ability of the subject to participate in the study, which places the subject at undue risk or complicates the interpretation of data.
Canada Specific:
Subject will be excluded from participation if any of the following apply:
Subject met any of the discontinuation criteria or whose cancer progressed on the current enzalutamide clinical study in which they are enrolling from.
Subject requires treatment with or plans to use any of the following:
New systemic therapy for their cancer (palliative radiation therapy is allowed). The treatment with agents administered during previous studies which was stopped and then restarted during this study does not represent new treatment.
Investigational therapy other than enzalutamide.
Subject is currently participating in an investigator-initiated interventional trial and receiving enzalutamide.
Subject has any concurrent disease, infection, or comorbid condition that interferes with the ability of the subject to participate in the study, which places the subject at undue risk or complicates the interpretation of data in the opinion of the investigator.

Intervenciones

drug

enzalutamide

Subjects will receive enzalutamide orally once daily at the same time each day.

drug

abiraterone acetate

Subjects enrolling from study 9785-CL-0011 or MDV3100-10 (PLATO) study may receive abiraterone acetate once daily and prednisone twice daily, in addition to enzalutamide

drug

prednisone

Subjects enrolling from study 9785-CL-0011 or MDV3100-10 (PLATO) study may receive abiraterone acetate once daily and prednisone twice daily, in addition to enzalutamide

drug

Leuprolide acetate

Subjects enrolling from study MDV3100-13 (EMBARK) study may receive leuprolide acetate once every 12 weeks in addition to enzalutamide once daily

Ubicaciones

Site AR54005

Buenos Aires, Buenos Aires F.D., Argentina

COMPLETED

Site AR54007

Rosario, Santa Fe Province, Argentina

ACTIVE_NOT_RECRUITING

Site AR54008

Buenos Aires, Argentina

ACTIVE_NOT_RECRUITING

Site AR54003

Cordorba, Argentina

COMPLETED

Site AR54006

San Miguel de Tucumán, Argentina

ACTIVE_NOT_RECRUITING

Site AR54002

San Miguel de Tucumán, Argentina

COMPLETED

Estudio de extensión abierto de fase 2 para sujetos con cáncer de próstata que participaron previamente en un estudio clínico de enzalutamida

Resumen

Descripción detallada

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

enzalutamide

abiraterone acetate

prednisone

Leuprolide acetate

Ubicaciones

Site AR54005

Site AR54007

Site AR54008

Site AR54003

Site AR54006

Site AR54002

Patrocinadores

Contactos

Astellas Pharma Global Development