A Study of TQ-B3525 Tablets in Subjects With PIK3CA and/or PIK3R1/2 Gene-altered Recurrent/Metastatic Advanced Gynecologic Tumors
A Open-label, Multicenter Phase II Study of TQ-B3525 Tablets in Subjects With PIK3CA and/or PIK3R1/2 Gene-altered Recurrent/Metastatic Advanced Gynecologic Tumors
Descripción general del estudio
Estado
Intervención / Tratamiento
Tipo de estudio
Inscripción (Anticipado)
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
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Jiangsu
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Changzhou, Jiangsu, Porcelana, 213003
- Aún no reclutando
- The First People's Hospital Of Changzhou
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Contacto:
- Weiqing Zhao, Doctor
- Correo electrónico: zwq7860@163.com
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Investigador principal:
- Weiqing Zhao, Doctor
-
Nanjing, Jiangsu, Porcelana
- Aún no reclutando
- Nanjing Drum Tower Hospital
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Contacto:
- Huaijun Zhou, Doctor
- Correo electrónico: zhouhj2007@126.com
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Investigador principal:
- Huaijun Zhou, Doctor
-
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Shanghai
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Shanghai, Shanghai, Porcelana, 200032
- Reclutamiento
- Fudan University Shanghai Cancer Center
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Contacto:
- Xiaohua Wu, Doctor
- Correo electrónico: wu.xh@fudan.edu.cn
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Investigador principal:
- Xiaohua Wu, Doctor
-
Shanghai, Shanghai, Porcelana, 200090
- Aún no reclutando
- Gynecology Hospital of Fudan University
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Contacto:
- Xiaojun Chen, Doctor
- Correo electrónico: cxjlhjj@163.com
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Investigador principal:
- Xiaojun Chen, Doctor
-
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Zhejiang
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Hangzhou, Zhejiang, Porcelana, 310016
- Aún no reclutando
- Sir Run Run Shaw Hospital Medical School Zhejiang University
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Contacto:
- Xian Wang, Doctor
- Correo electrónico: yedw@srrsh.com
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Investigador principal:
- Xian Wang, Doctor
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
1. Pathologically confirmed malignant gynecological neoplasm. 2. Has PIK3CA and/or PIK3R1/2 Gene-altered. 3.Unresectable, locally advanced recurrent and/or metastatic tumors, has at least 1 measurable lesion.
4.Failed with standard treatment or has no effective treatment. 5. 18 years and older, Eastern Cooperative Oncology Group(ECOG) performance status score of 0 to 1, Life expectancy ≥ 3 months.
6. Male or female subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 6 months after the last dose of study (such as intrauterine devices , contraceptives or condoms) ；No pregnant or breastfeeding women, and a negative pregnancy test are received within 7 days before the first administration.
7.Understood and signed an informed consent form.
Exclusion Criteria:
1.Has untreated or active central nervous system metastases. 2.Has diagnosed and/or treated additional malignancy within 3 years prior to the first administration.
3. Insufficient hematopoietic function of bone marrow. 4. Dysfunction of liver and kidney. 5. Bleeding risk. 6. Dysfunction of gastrointestinal tract. 7.Dysfunction of heart and cerebral vessels. 8.Has received PI3K, AKT, mTOR inhibitor. 9.Has participated in other clinical trails within 30 days. 10. Has received surgery, or unhealed wounds within 4 weeks before the first administration.
11. Has received organ grafting, or hematopoietic stem cell transplantation within 60 days before the first administration, or host versus graft reaction.
12. The patients required immunosuppressor, or the whole-body, or absorbable local hormone therapy for immunosuppression purposes and continued to use within 7 days before the initial administration (daily dose of glucocorticoid <10 mg, except metacortandracin or other therapeutic hormones and so on).
13. Has active infections. 14. Has human immunodeficiency virus (HIV). 15. Pregnant or lactating women. 16. Has psychotropic substances abuse or a mental disorder. 17. Has other conditions that make it inappropriate for the patient to be enrolled based on investigator's opinion.
18. Patient's compliance is inadequate.
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: TQ-B3525 tablet
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TQ-B3525 tablet administered orally once a day.
Each cycle is 28 days.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Overall response rate (ORR) assessed by Independent Review Committee
Periodo de tiempo: up to 48 weeks
|
Percentage of participants achieving complete response (CR) and partial response (PR) based on IRC.
|
up to 48 weeks
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Overall response rate (ORR) assessed by Investigator
Periodo de tiempo: up to 48 weeks
|
Percentage of participants achieving complete response (CR) and partial response (PR) assessed by investigator.
|
up to 48 weeks
|
|
Tasa de control de enfermedades (DCR)
Periodo de tiempo: hasta 48 semanas
|
Porcentaje de sujetos que logran respuesta completa (CR) y respuesta parcial (PR) y enfermedad estable (SD).
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hasta 48 semanas
|
|
Duration of disease remission (DOR)
Periodo de tiempo: up to 48 weeks
|
The time from the first evaluation of the subject as CR or PR to the first evaluation of the subject as PD or death (whichever occurs first).
|
up to 48 weeks
|
|
Progression-free survival (PFS)
Periodo de tiempo: up to 48 weeks
|
PFS was defined as the time from the date of study enrollment to the date of the first of the following events, objective disease progression or death due to any cause.
|
up to 48 weeks
|
|
Overall survival (OS)
Periodo de tiempo: up to 72 weeks
|
OS defined as the time from the first dose to death from any cause.
Survival time was censored at the date of last contact for patients who were still alive or lost to follow-up.
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up to 72 weeks
|
|
DOR rate (≥ 6 months) (percentage of subjects with disease remission duration ≥ 6 months)
Periodo de tiempo: up to 48 weeks
|
The percentage of subjects achieving CR or PR was recorded for the first time to 6 months after the first time of objective tumor progression or death due to any cause (whichever occurred first) was recorded.
|
up to 48 weeks
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- TQ-B3525-II-03
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.
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