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
Visão geral do estudo
Status
Intervenção / Tratamento
Tipo de estudo
Inscrição (Antecipado)
Estágio
- Fase 2
Contactos e Locais
Locais de estudo
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Jiangsu
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Changzhou, Jiangsu, China, 213003
- Ainda não está recrutando
- The First People's Hospital of Changzhou
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Contato:
- Weiqing Zhao, Doctor
- E-mail: zwq7860@163.com
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Investigador principal:
- Weiqing Zhao, Doctor
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Nanjing, Jiangsu, China
- Ainda não está recrutando
- Nanjing Drum Tower Hospital
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Contato:
- Huaijun Zhou, Doctor
- E-mail: zhouhj2007@126.com
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Investigador principal:
- Huaijun Zhou, Doctor
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Shanghai
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Shanghai, Shanghai, China, 200032
- Recrutamento
- Fudan University Shanghai Cancer Center
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Contato:
- Xiaohua Wu, Doctor
- E-mail: wu.xh@fudan.edu.cn
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Investigador principal:
- Xiaohua Wu, Doctor
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Shanghai, Shanghai, China, 200090
- Ainda não está recrutando
- Gynecology Hospital of Fudan University
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Contato:
- Xiaojun Chen, Doctor
- E-mail: cxjlhjj@163.com
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Investigador principal:
- Xiaojun Chen, Doctor
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Zhejiang
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Hangzhou, Zhejiang, China, 310016
- Ainda não está recrutando
- Sir Run Run Shaw Hospital Medical School Zhejiang University
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Contato:
- Xian Wang, Doctor
- E-mail: yedw@srrsh.com
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Investigador principal:
- Xian Wang, Doctor
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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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.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Overall response rate (ORR) assessed by Independent Review Committee
Prazo: up to 48 weeks
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Percentage of participants achieving complete response (CR) and partial response (PR) based on IRC.
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up to 48 weeks
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Overall response rate (ORR) assessed by Investigator
Prazo: up to 48 weeks
|
Percentage of participants achieving complete response (CR) and partial response (PR) assessed by investigator.
|
up to 48 weeks
|
|
Taxa de controle de doenças (DCR)
Prazo: até 48 semanas
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Porcentagem de indivíduos que atingiram resposta completa (CR) e resposta parcial (PR) e doença estável (SD).
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até 48 semanas
|
|
Duration of disease remission (DOR)
Prazo: up to 48 weeks
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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)
Prazo: 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)
Prazo: 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
|
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DOR rate (≥ 6 months) (percentage of subjects with disease remission duration ≥ 6 months)
Prazo: 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.
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up to 48 weeks
|
Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Antecipado)
Conclusão do estudo (Antecipado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- TQ-B3525-II-03
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