- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT05327621
Pamiparib in mCRPC With HRD or BRCA1/2 Mutation
A Single Arm, Open-label, Phase II Study to Assess the Efficacy of Pamiparib in Metastatic Castration-Resistant Prostate Cancer Patients With Homologous Recombination Deficiency (HRD) or BRCA1/2 Mutation
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
Tipo de estudio
Inscripción (Anticipado)
Fase
- Fase 2
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Fangjian Zhou, M.D.
- Número de teléfono: 020-87343656
- Correo electrónico: zhoufj@sysucc.org.cn
Ubicaciones de estudio
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Guangdong
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Guangzhou, Guangdong, Porcelana, 510060
- Reclutamiento
- Sun Yat-sen University Cancer Center
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Contacto:
- Fangjian Zhou, M.D.
- Número de teléfono: 020-87343656
- Correo electrónico: zhoufj@sysucc.org.cn
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- ≥18 years old, male
- Have a histologically or cytologically confirmed adenocarcinoma or poorly differentiated carcinoma without neuroendocrine differentiation of the prostate. Mixed histology is accepted, except for small cell carcinoma.
- Have a deleterious mutation in BRCA1/2 , or HRD score ≥ 9.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤1
- BPI<4
- Metastatic Castration-resistant Prostate Cancer (mCRPC): Presence of measurable target lesion according to RECIST criteria v1.1
- Male subject has been surgically or medically sterilized and has serum testosterone level ≤1.73nmol/L.
- Unsterilized male subject uses an acceptable method of contraception (defined as a barrier method with spermicide) to prevent pregnancy during the duration of the study and for 6 months after the last dose of Pamiparib.
- Experienced disease progression after having received at least 1 prior next-generation androgen receptor-targeted therapies, for metastatic castration-resistant disease.
- Capable of swallowing the whole capsule.
Subjects must have normal organ and bone marrow function at baseline, as defined below:
Hemoglobin ≥ 9.0 g/dL at least 28 days after transfusion . Absolute neutrophil count ≥ 1.5 × 10^9/L. Platelet count ≥ 100 × 10^9/L. Total bilirubin ≤ 1.5 × the upper limit of normal (ULN) specified. Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase/alanine aminotransferase (ALT) serum glutamic pyruvic transaminase) ≤ 3 × the specified ULN, unless liver metastases are present, in which case it must be ≤ 5 × ULN.
- Agree to sign informed consent form
- Agree not to participate in other interventional trials during this trial.
Exclusion Criteria:
Subjects should not enter the study if any of the following exclusion criteria are fulfilled:
- Acute toxicity (CTCAE > grade 2) due to prior cancer therapy.
- Received chemotherapy, endocrine therapy, biotherapy, radionuclide therapy, immunotherapy, experimental drugs, proprietary anticancer drugs or Chinese herbal medicines within 5 (if known) half-lives or 14 days(if unknown) prior to the first day of taking Pamiparib; For bisphosphonates or approved bone targeting therapy, Pamiparib must be administered at a steady dose for ≥28 days prior to the first day of taking Pamiparib.
- Received radiation therapy within 21 days.
- Prior treatment with any PARP inhibitor. Prior chemotherapy with mitoxantrone or platinum-based chemotherapy or cyclophosphamide. Prior treatment with sipuleucel-T or immune check point inhibitors are allowed.
- Subjects with major surgery within 2 weeks before starting study treatment. Subjects expected to receive major surgery during the trial.
- Active second malignancy, with the exception of curatively treated non-melanoma skin cancer, carcinoma in situ, or superficial bladder cancer
- Symptomatic and/or untreated central nervous system metastases
- Immunocompromised subjects, such as those with positive human immunodeficiency virus (HIV) serology.
- Subjects with known active hepatitis (e.g. hepatitis B or C).
- The subject has a serious cardiovascular disease. ( For example, but not limited to: uncontrolled arrhythmia, myocardial infarction)
- Concomitant use of strong CYP3A inducers or moderate CYP3A inducers . If half-lives is known, a 5 half-lives washout period is required before the start of Pamiparib therapy and a 2-week washout period is required when the half-lives is unknown.
- History of intolerance to Pamiparib capsule excipients
- Excluded by investigators
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Pamiparib
Tablets 20mg per os : 40 mg / bid every day in continuous.
Patients will be treated with Pamiparib.
Cycles are defined in 28-day periods.
Disease response will be assessed every 8 weeks (RECIST 1.1).
Safety will be assessed continuously.
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40 mg bid per os , 28 day cycle, number of cycles: until progression or unacceptable toxicity develops.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Radiologic Progression-free Survival (rPFS)
Periodo de tiempo: 3 years
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Radiologic progression-free survival will be assessed from the time of the first dose to radiologic disease progression or death from any cause, whichever comes first.
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3 years
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Tasa de beneficio clínico
Periodo de tiempo: 3 años
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según RECIST, es una respuesta completa (RC), una respuesta parcial (PR) o una enfermedad estable (SD) que dura al menos 16 semanas
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3 años
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Objective Response Rate (ORR)
Periodo de tiempo: From enrollment to primary completion of study (up to approximately 3 years)
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Proportion of patients in complete remission (CR) plus partial remission (PR)
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From enrollment to primary completion of study (up to approximately 3 years)
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Duration of Response (DOR)
Periodo de tiempo: From enrollment to primary completion of study (up to approximately 3 years)
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Time from the start of the first assessment of the tumor as CR or PR to the first assessment of PD (Progressive Disease) or death from any cause.
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From enrollment to primary completion of study (up to approximately 3 years)
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Time to Response (TTR)
Periodo de tiempo: From enrollment to primary completion of study (up to approximately 3 years)
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Time from initiation of treatment to first assessment of tumor as CR or PR.
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From enrollment to primary completion of study (up to approximately 3 years)
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Prostate Specific Antigen (PSA) Response Rate
Periodo de tiempo: From enrollment to primary completion of study (up to approximately 3 years)
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Proportion of patients with a 50% decrease in PSA from baseline
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From enrollment to primary completion of study (up to approximately 3 years)
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Time to PSA Progression
Periodo de tiempo: From enrollment to primary completion of study (up to approximately 3 years)
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Time from initiation of treatment to two consecutive 50% PSA increases from baseline level
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From enrollment to primary completion of study (up to approximately 3 years)
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Overall Survival (OS)
Periodo de tiempo: From enrollment to primary completion of study (up to approximately 3 years)
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Time between the start of treatment and death from any cause
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From enrollment to primary completion of study (up to approximately 3 years)
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Adverse events
Periodo de tiempo: 3 years
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Adverse events are graded according to the CTCAE V4.03
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3 years
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
rPFS stratified by baseline HRD score (HRD score threshold is defined as 9)
Periodo de tiempo: 3 years
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The rPFS is defined as the duration from Pamiparib initiation to radiologic disease progression or death from any cause, whichever comes first.
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3 years
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OS stratified by baseline HRD score (HRD score threshold is defined as 9)
Periodo de tiempo: 3 years
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The OS is defined as the duration from Pamiparib initiation to any death.
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3 years
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Anticipado)
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2021-FXY-385
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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