A Study to Evaluate the Effects of Combining Cabazitaxel With Cisplatin Given Every 3 Weeks in Patients With Advanced Solid Cancer
A Dose-Escalation Study Of The Safety, Tolerability, And Pharmacokinetics Of Cabazitaxel In Combination With Cisplatin Administered Every 3 Weeks In Subjects With Advanced Solid Malignancies
This study is designed as a phase 1, multicenter, open-label, single arm, dose-escalation, study of Cabazitaxel in combination with cisplatin, to determine safety, pharmacokinetics (PK), and efficacy in solid tumors (parts 1 and 2) and single sequence, two-treatment, crossover studies to determine the effect of strong CYP3A4 inhibition and induction on the PK of Cabazitaxel in patients with solid tumors (part 3 and part 4, respectively).
There are 4 parts to the study:
Part 1: Determine the Dose Limiting Toxicities (DLT)'s and Maximum Tolerated Dose (MTD) based on safety.
Part 2: Determine the anti-tumor activity of the combination regimen at the Maximum Tolerated Dose (MTD) in an extended cohort of patients.
Part 3: Determine the effect of a strong CYP3A4 inhibitor (ketoconazole) on the pharmacokinetic (PK) of Cabazitaxel.
Part 4: Determine the effect of a strong CYP3A4 inducer (rifampin) on the pharmacokinetic (PK) of Cabazitaxel.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
The total duration on the study per subject will be about 26 weeks broken down as follows:
- A maximum of 21-day screening phase,
- 21-days (+/- 2 weeks) study treatment cycles,
- 30-day follow-up visit after the last dose of study medication.
- Cut-off date for parts 1, 2, 3 and 4: when the last patient has completed 6 cycles (parts 1 and 2) or 2 cycles (parts 3 and 4) of treatment or discontinued study treatment (for disease progression, unacceptable toxicity, withdrawal of consent, or investigator's decision to withdraw), whichever comes first, in the corresponding part.
Patients still receiving treatment at the cut-off date may continue to receive treatment beyond the cut-off date at investigator's discretion if benefiting.
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 1
Contactos e Locais
Locais de estudo
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California
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Los Angeles, California, Estados Unidos, 90048
- Investigational Site Number 840008
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San Diego, California, Estados Unidos, 92123
- Investigational Site Number 840003
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Illinois
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Decatur, Illinois, Estados Unidos, 62526
- Investigational Site Number 840010
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Maryland
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Baltimore, Maryland, Estados Unidos, 21201
- Investigational Site Number 840002
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Missouri
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St Louis, Missouri, Estados Unidos, 63110
- Investigational Site Number 840006
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Ohio
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Cincinnati, Ohio, Estados Unidos, 45267-0542
- Investigational Site Number 840007
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Texas
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San Antonio, Texas, Estados Unidos, 78229
- Investigational Site Number 840005
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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:
- confirmed metastatic or unremovable advanced solid malignancy that is metastatic or unresectable, and for which standard curative measures do not exist, but for which cisplatin based therapy is appropriate
- signed informed consent
Exclusion criteria
- limited physical functioning (as evaluated by the Eastern Cooperative Oncology Group (ECOG) scale)
- inability to follow study requirements and schedule
- treatment of cancer within 3 weeks of study, concurrent treatment in another clinical trial or with any other cancer therapy
- serious medical illness at same time of study and/or significantly abnormal lab reports
- lack of pregnancy contraception (women of childbearing potential), pregnancy, or breast feeding.
- Women of childbearing potential not protected by highly effective contraceptive method of birth control OTHER than hormonal contraception (Part 4 only).
- prior significant hearing or kidney problems
- continued toxic effects of prior chemotherapy
- cancers that cannot be physically measured (Part 2 only)
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: 1
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
|---|---|
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Dose Limiting Toxicities (DLT)'s of the combination of cabazitaxel and cisplatin (part 1)
Prazo: first cycle (i.e.3 weeks)
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first cycle (i.e.3 weeks)
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Objective response ratio (Complete response (CR) and partial response (PR)) (part 2)
Prazo: up to 6 cycles, ie 18 weeks
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up to 6 cycles, ie 18 weeks
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Pharmacokinetics (PK) of cabazitaxel (part 3 and 4)
Prazo: up to 6 cycles, ie 18 weeks
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up to 6 cycles, ie 18 weeks
|
Medidas de resultados secundários
Medida de resultado |
Prazo |
|---|---|
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Time to progression (TTP) (part 1 and 2)
Prazo: up to 6 cycles, ie 18 weeks
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up to 6 cycles, ie 18 weeks
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Duration of response (DR) (Part 1 and 2)
Prazo: up to 6 cycles, ie 18 weeks
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up to 6 cycles, ie 18 weeks
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Cabazitaxel pharmacokinetic (part 1 and 2)
Prazo: up to 6 cycles, ie 18 weeks
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up to 6 cycles, ie 18 weeks
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Colaboradores e Investigadores
Patrocinador
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Outros números de identificação do estudo
- TCD10870
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