- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT03057366
A Study of [14 C]-Pevonedistat in Participants With Advanced Solid Tumors
A Phase 1 Study to Assess Mass Balance, Pharmacokinetics, and Metabolism of [14C]-Pevonedistat in Patients With Advanced Solid Tumors
Visão geral do estudo
Status
Descrição detalhada
The drug being tested in this study is called Pevonedistat. Pevonedistat is being tested to treat people with advanced solid tumors.
The study will enroll approximately 4 to 6 pharmacokinetics (PK)-evaluable participants in part A. After completion of the mass balance and absorption, distribution, metabolism, excretion (ADME) assessment in Part A of the study, eligible participants will have the opportunity to continue into Part B at a secondary study site, which would begin in approximately 2 weeks of completion of Part A.
- [14C]-Pevonedistat 25 mg/m^2
- Part B (optional): Pevonedistat in combination with chemotherapy regimens (Pevonedistat 25 mg/m^2 + docetaxel 75 mg/m^2 or pevonedistat 20 mg/m^2 + carboplatin 20 mg/m^2 + paclitaxel 175 mg/m^2)
All participants will receive study drug via intravenous route. This multi-center trial will be conducted in Hungary. Participants will remain confined to the study site for 9 to 14 days in Part A. Participation in Part B is optional, participants will be re-evaluated for inclusion/exclusion criteria before administrating treatment. Participants will undergo treatment in Part B for a maximum of 12 cycles (21 days cycle each) and will include approximately 36 weeks for Part A and B combined. Participants will attend an end of study visit 30 days after the last dose of study drug in both Part A and B.
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 1
Contactos e Locais
Locais de estudo
-
-
-
Budapest, Hungria, 1062
- Magyar Honvédség Egészségügyi Központ Onkológiai Osztály
-
Budapest, Hungria, 1076
- PRA Magyarország Kft. Fázis I-es Klinikai Farmakológiai Vizsgálóhely
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Have a histologically or cytologically confirmed metastatic or locally advanced and incurable solid tumor that is felt to be appropriate for treatment with one of the 2 chemotherapy regimens in Part B of this study (carboplatin+paclitaxel or docetaxel), or have progressed despite prior standard therapy, or for whom conventional therapy is not considered effective. The tumor must be radiographically or clinically evaluable and/or measurable.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
- Expected survival longer than 3 months from enrollment in the study.
- Recovered (that is, less than or equal to [<=] Grade 1 toxicity) from the effects of prior antineoplastic therapy.
Exclusion Criteria:
- Has irregular defecation patterns (less than 1 defecation per 2 days or excessive diarrhea) and/or has a history of changes in bowel habits with daily routine or environment changes.
- Prior treatment with radiation therapy involving greater than or equal to (>=) 25% of the hematopoietically active bone marrow.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Outro
- Modelo Intervencional: Atribuição sequencial
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
Experimental: [14C]-Pevonedistat 25 mg/m^2
[14C]-pevonedistat (containing approximately 60-98 mCi [approximately 2.22-3.626
MBq] of radioactive tracer), infusion, intravenously, single dose on Day 1 of Week 1 in Part A. After completion of Part A, participants will have opportunity to continue into Part B. Participant will receive Pevonedistat 25 mg/m^2, infusion, intravenously, single dose on Days 1, 3 and 5 of each 21 day cycle, for up to 12 cycles along with docetaxel 75 mg/m^2, infusion, intravenously, over 1 hour on Day 1 of each 21 day cycle; or pevonedistat 20 mg/m^2, infusion, intravenously, single dose on Days 1, 3 and 5 of each 21 day cycle, for up to 12 cycles, followed by paclitaxel 175 mg/m^2, infusion, intravenously, over 3 hours along with carboplatin 20 mg/m^2, infusion, intravenously, over 30 minutes on Day 1 of 21 each cycle up to 12 cycles.
Based on investigator and sponsor discretion, participants deriving benefits will continue to receive current combination therapy or pevonedistat alone beyond 12 cycles.
|
Pevonedistat infusão intravenosa.
Outros nomes:
Infusão intravenosa de docetaxel.
Infusão intravenosa de carboplatina.
Infusão intravenosa de paclitaxel.
[14C]-Pevonedistat intravenous infusion.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
---|---|
Part A: Cmax: Maximum Observed Plasma and Whole Blood Concentration for Pevonedistat
Prazo: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
|
Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
|
Part A: Tmax: Time to Reach the Maximum Plasma and Whole Blood Concentration (Cmax) for Pevonedistat
Prazo: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
|
Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
|
Part A: AUClast: Area Under the Plasma and Whole Blood Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for Pevonedistat
Prazo: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
|
Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
|
Part A: Cmax: Maximum Observed Plasma and Whole Blood TRA Concentration for [14C]-Pevonedistat Drug-related Material
Prazo: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
|
Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
|
Part A: Tmax: Time to Reach the Maximum Plasma and Whole Blood TRA Concentration (Cmax) for [14C]-Pevonedistat Drug-related Material
Prazo: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
|
Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
|
Part A: AUClast: Area Under the Plasma and Whole Blood TRA Concentration Curve From Time 0 to Time of the Last Quantifiable Concentration for [14C]-Pevonedistat Drug-related Material
Prazo: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
|
Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
|
Part A: Aeurine,14C: Cumulative Amount of [14C]-Pevonedistat Excreted in Urine up to the Last Sampling Interval
Prazo: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
|
Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
|
Part A: Aefeces,14C: Cumulative Amount of [14C]-Pevonedistat Excreted in Feces up to the Last Sampling Interval
Prazo: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
|
Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
|
Part A: Aetotal,14C: Total Cumulative Excretion of [14C]-Pevonedistat From the Body
Prazo: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
|
Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
|
Part A: Aeurine: Cumulative Amount of Pevonedistat Dose Excreted in Urine at 144-168 Hours Post-dose
Prazo: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
|
Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
|
Part A: Feurine: Cumulative Percentage of Pevonedistat Dose Excreted in Urine at 144-168 Hours Post-dose
Prazo: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
|
Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
|
Part A: Renal Clearance (CLR) for Pevonedistat
Prazo: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
|
Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Prazo: Part A: From first dose of study drug in Part A up to Day 31; Part B: From first dose of study drug in Part B up to Cycle 11 Day 35 (Cycle length is equal to [=] 21 days)
|
Part A: From first dose of study drug in Part A up to Day 31; Part B: From first dose of study drug in Part B up to Cycle 11 Day 35 (Cycle length is equal to [=] 21 days)
|
|
Part A: Percent Distribution of Total Radioactivity (TRA) for Pevonedistat and Its Metabolites in Plasma, Urine and Feces
Prazo: Up to 168 hours post-dose
|
Up to 168 hours post-dose
|
|
Part B: Number of Participants With Best Overall Response as Per Investigator's Assessment
Prazo: Up to Cycle 11 (Cycle length =21 days)
|
The best overall response was defined as the participants with best response among complete response (CR) or partial response (PR) or stable disease (SD), or progressive disease (PD).
It was assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
CR: disappearance of all target lesions.
Any pathological lymph nodes must have reduction in short axis to less than (<) 10 millimeter (mm).
PR: at least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters as the best overall response after randomization.
SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study).
|
Up to Cycle 11 (Cycle length =21 days)
|
Colaboradores e Investigadores
Patrocinador
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
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 (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
- Pevonedistat-1013
- U1111-1169-6648 (Identificador de registro: WHO)
- 2016-004132-37 (Número EudraCT)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
Ensaios clínicos em Pevonedistate
-
Vanderbilt-Ingram Cancer CenterNational Cancer Institute (NCI)Ativo, não recrutandoSíndromes Mielodisplásicas | Neoplasia MieloproliferativaEstados Unidos
-
Beat AML, LLCRecrutamentoLeucemia Mielóide Aguda Não Tratada AnteriormenteEstados Unidos