Estudo para Avaliar a Segurança e a Tolerabilidade de Camizestrant em Combinação com Atirmociclib em Mulheres com Cancro da Mama Avançado (SERENA-1b)
Um Estudo de Fase IIa, Aberto, para Avaliar a Segurança, a Farmacocinética e a Eficácia Preliminar do Camizestrant em Combinação com o Atirmociclib em Participantes com Cancro da Mama Avançado ER-positivo, HER2-negativo (SERENA-1b)
A study to investigate camizestrant in combination with atirmociclib in participants with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer previously treated with a cyclin dependent kinase 4/6 (CDK4/6) inhibitor.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
This is a Phase IIa, sequential assignment, non- randomized, open-label treatment study to determine the safety, tolerability, pharmacokinetics (PK) and preliminary anti-tumor activity of camizestrant in combination with atirmociclib.
The single-arm study includes:
- Screening period
- Atirmociclib single dose period
- Doublet intervention period
- Post-treatment follow-up period
Tipo de estudo
Inscrição (Estimado)
Estágio
- Fase 2
Contactos e Locais
Contato de estudo
- Nome: AstraZeneca Clinical Study Information Center
- Número de telefone: 1-877-240-9479
- E-mail: information.center@astrazeneca.com
Locais de estudo
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Missouri
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St Louis, Missouri, Estados Unidos, 63108
- Recrutamento
- Research Site
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Rhode Island
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East Providence, Rhode Island, Estados Unidos, 02915
- Recrutamento
- Research Site
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Tennessee
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Nashville, Tennessee, Estados Unidos, 37203
- Recrutamento
- Research Site
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Cambridge, Reino Unido, CB2 0QQ
- Recrutamento
- Research Site
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London, Reino Unido, EC1M6BQ
- Recrutamento
- Research Site
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Manchester, Reino Unido, M20 4GJ
- Recrutamento
- Research Site
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Main Inclusion Criteria:
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Participants with advanced adenocarcinoma of the breast and must have received prior adequate therapy in accordance with local practice for their tumor type and stage of disease.
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Metastatic or locoregionally recurrent disease and radiological or objective evidence of progression on or after the last systemic therapy prior to starting investigational medicinal products.
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Eastern cooperative oncology group (ECOG)/World Health Organization (WHO) performance status 0 to 1, and a minimum life expectancy of 12 weeks.
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At least one lesion that is measurable and/or non-measurable, as per RECIST 1.1 and that can be accurately assessed at baseline and is suitable for repeated assessment by computed tomography (CT), magnetic resonance imaging (MRI), or plain X-ray, or clinical examination.
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Menopausal status
- Pre-menopausal women must start GnRH agonist therapy at least 4 weeks before study treatment and continue throughout the study.
- Post-menopausal women must meet one of these criteria: bilateral oophorectomy, age ≥60 years, age ≥50 years with ≥12 months amenorrhea and intact uterus without hormonal therapy, or age <60 years with ≥12 months amenorrhea and post-menopausal hormone levels.
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Histological or cytological confirmation of adenocarcinoma of the breast.
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Participants of childbearing potential must agree to use one highly effective contraceptive measure.
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Documentation of ER-positive tumor irrespective of progesterone receptor status.
Main Exclusion Criteria:
- A participant who has received 2 or more lines of CDK4/6 inhibitors in the advanced disease setting.
- A participant who has received prior camizestrant or atirmociclib treatment in the advanced disease setting.
- Patients previously treated with other next generation selective estrogen receptor degrader (SERDs) or other experimental ETs in the advanced disease setting.
- Patients previously treated with other experimental cyclin-dependent kinase (CDK) inhibitors are not eligible.
- Inability to swallow oral medications.
- Any unresolved toxicities of Grade ≥ 2 from prior anti-cancer therapy (with the exception of alopecia).
- Presence of life-threatening metastatic visceral disease.
- Any evidence of severe or uncontrolled systemic diseases.
- Contraindication to or known intolerance/hypersensitivity of/to camizestrant or atirmociclib.
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: Camizestrant + Atirmociclib
Participants will receive a single dose of atirmociclib on Day -1 followed by combination of camizestrant and atirmociclib from Day 1. |
Camizestrant will be administered orally. Atirmociclib will be administered orally. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Number of participants with adverse events (AEs) and serious AEs
Prazo: Up to Post-Treatment Follow up (Day 30 Post Dose)
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To investigate the safety and tolerability of camizestrant in combination with atirmociclib. |
Up to Post-Treatment Follow up (Day 30 Post Dose)
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Maximum concentration observed (Cmax)
Prazo: At pre-defined intervals from Day -1 to Day 57
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To characterize the PK profile and parameters of atirmociclib. |
At pre-defined intervals from Day -1 to Day 57
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|
Area under plasma concentration-time curve from time 0 to infinity (AUCinf)
Prazo: At pre-defined intervals from Day -1 to Day 57
|
To characterize the PK profile and parameters of atirmociclib. |
At pre-defined intervals from Day -1 to Day 57
|
|
Area under plasma concentration-time curve from time 0 to last quantifiable concentration (AUClast)
Prazo: At pre-defined intervals from Day -1 to Day 57
|
To characterize the PK profile and parameters of atirmociclib. |
At pre-defined intervals from Day -1 to Day 57
|
|
Time to reach maximum (peak) plasma concentration following drug administration (tmax)
Prazo: At pre-defined intervals from Day -1 to Day 57
|
To characterize the PK profile and parameters of atirmociclib. |
At pre-defined intervals from Day -1 to Day 57
|
|
Terminal elimination rate constant (λz)
Prazo: At pre-defined intervals from Day -1 to Day 57
|
To characterize the PK profile and parameters of atirmociclib. |
At pre-defined intervals from Day -1 to Day 57
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Terminal elimination half-life (t½λz)
Prazo: At pre-defined intervals from Day -1 to Day 57
|
To characterize the PK profile and parameters of atirmociclib. |
At pre-defined intervals from Day -1 to Day 57
|
|
Apparent total body clearance (CL/F)
Prazo: At pre-defined intervals from Day -1 to Day 57
|
To characterize the PK profile and parameters of atirmociclib. |
At pre-defined intervals from Day -1 to Day 57
|
|
Apparent volume of distribution at steady state (Vss/F)
Prazo: At pre-defined intervals from Day -1 to Day 57
|
To characterize the PK profile and parameters of atirmociclib. |
At pre-defined intervals from Day -1 to Day 57
|
|
Apparent volume of distribution based on the terminal phase (Vz/F)
Prazo: At pre-defined intervals from Day -1 to Day 57
|
To characterize the PK profile and parameters of atirmociclib. |
At pre-defined intervals from Day -1 to Day 57
|
|
Maximum concentration observed at steady state (Cssmax)
Prazo: At pre-defined intervals from Day -1 to Day 57
|
To characterise the PK profile and parameters of atirmociclib and camizestrant after administration in combination with each other. |
At pre-defined intervals from Day -1 to Day 57
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Area under the curve from 0 to the end of dosing interval (AUC0-tau)
Prazo: At pre-defined intervals from Day -1 to Day 57
|
To characterise the PK profile and parameters of atirmociclib and camizestrant after administration in combination with each other. |
At pre-defined intervals from Day -1 to Day 57
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Area under the curve from 0 to the end of dosing interval at steady state (AUCss0-tau)
Prazo: At pre-defined intervals from Day -1 to Day 57
|
To characterise the PK profile and parameters of atirmociclib and camizestrant after administration in combination with each other. |
At pre-defined intervals from Day -1 to Day 57
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Time to reach maximum plasma concentration at steady state (tssmax)
Prazo: At pre-defined intervals from Day -1 to Day 57
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To characterise the PK profile and parameters of atirmociclib and camizestrant after administration in combination with each other. |
At pre-defined intervals from Day -1 to Day 57
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Objective Response Rate (ORR)
Prazo: Up to 2 years
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To assess the preliminary anti-tumor activity and efficacy of camizestrant in combination with atirmociclib. |
Up to 2 years
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Duration of Response (DOR)
Prazo: Up to 2 years
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To assess the preliminary anti-tumor activity and efficacy of camizestrant in combination with atirmociclib. |
Up to 2 years
|
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Clinical Benefit Rate at 24 Weeks (CBR24)
Prazo: At 24 weeks
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To assess the preliminary anti-tumor activity and efficacy of camizestrant in combination with atirmociclib. |
At 24 weeks
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Percentage change in tumor size
Prazo: Up to 2 years
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To assess the preliminary anti-tumor activity and efficacy of camizestrant in combination with atirmociclib. |
Up to 2 years
|
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Progression Free Survival (PFS)
Prazo: Up to 2 years
|
To assess the preliminary anti-tumor activity and efficacy of camizestrant in combination with atirmociclib. |
Up to 2 years
|
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Progression-free survival landmark 6 months (PFSLM6m)
Prazo: At 6 months
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To assess the preliminary anti-tumor activity and efficacy of camizestrant in combination with atirmociclib. |
At 6 months
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Progression-free survival landmark 12 months (PFSLM12m)
Prazo: At 12 months
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To assess the preliminary anti-tumor activity and efficacy of camizestrant in combination with atirmociclib. |
At 12 months
|
Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
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
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- D853CC00001
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Prazo de Compartilhamento de IPD
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Critérios de acesso de compartilhamento IPD
When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- SEIVA
Informações sobre medicamentos e dispositivos, documentos de estudo
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