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- Ensaio Clínico NCT01688791
A Study of MK-8109 (Vintafolide) Given Alone or With Chemotherapy in Participants With Advanced Cancers (MK-8109-001)
9 de fevereiro de 2015 atualizado por: Endocyte
A Phase I Dose Escalation Study Evaluating Vintafolide (MK-8109) Chemotherapy Alone or in Combination in Adult Subjects With Advanced Cancers
This trial will be conducted in three parts.
Part A is a dose escalation trial followed by a dose confirmation trial in folate receptor (FR) 100% endometrial cancer participants.
The primary hypothesis of this trial is that administration of vintafolide in combination with carboplatin and paclitaxel is safe and tolerable.
Part B is a single dose, dose escalation, pharmacokinetic (PK), and QTc interval trial.
The primary objectives include determination of the maximum single tolerated dose of vintafolide and to evaluate the effect of this single maximum dose on the QTc interval.
Part C is a weekly dose escalation trial of vintafolide followed by a dose confirmation.
The primary hypothesis of this part is that weekly vintafolide has acceptable safety and tolerability in participants with advanced cancers.
Visão geral do estudo
Status
Rescindido
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Real)
37
Estágio
- Fase 1
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion criteria for all participants:
- Histologically-confirmed metastatic or locally advanced solid tumor that has failed to respond to standard therapy, progressed despite standard therapy, or for which standard therapy does not exist or is unacceptable to the participant
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- At least one measurable metastatic or recurrent lesion
- No history of a previous malignancy with the exception of cervical intraepithelial neoplasia, basal cell carcinoma of the skin, or adequately treated localized prostate carcinoma; or has undergone potentially curative therapy with no evidence of disease for five years
- Adequate organ function
- Female participants of childbearing potential must be willing to use acceptable methods of birth control or abstain from heterosexual activity for the course of the study through 90 days after the last dose of study therapy
- Male participants must agree to use an adequate method of contraception for heterosexual activity starting with the first dose of study therapy through 90 days after the last dose of study therapy
Inclusion criteria for Part A:
- Tumor lesions characterized as folate receptor (FR) 100% as determined by an etarfolide Sequential Single Photon Emission Computed Tomography (SPECT) and CT scan
- Histologically-confirmed diagnosis of locally advanced or metastatic or recurrent endometrial cancer
Inclusion criteria for Parts B & C:
- Must have an etarfolatide SPECT/CT scan to determine FR status
Exclusion criteria for all participants:
- Part A & Part C if enrolled after completion of Part B: Chemotherapy, radiotherapy, or biological therapy (including monoclonal antibodies) within 4 weeks prior to drug administration, or not recovered from adverse events due to agents administered more than 4 weeks earlier
- Part B: Chemotherapy, radiotherapy, or biological therapy (including monoclonal antibodies) within 3 weeks prior to drug administration, or not recovered from adverse events due to agents administered more than 4 weeks earlier
- Currently participating or has participated in a study with an investigational compound or device within 28 days of initial dosing on this study
- Part A, dose escalation, Parts B and C: More than 3 prior cytotoxic regimens for metastatic disease.
- Part A, dose confirmation: Has received more than 2 prior cytotoxic regimens for metastatic disease.
- Primary central nervous system (CNS) tumor
- Active CNS metastases and/or carcinomatous meningitis.
- Known hypersensitivity to the components of the study therapy or its analogs
- Recent (i.e., ≤ 6 weeks) history of abdominal surgery or peritonitis
- Bowel occlusion or sub-occlusion
- Prior whole abdominal or whole pelvis radiation therapy or radiation therapy to >10% of the bone marrow at any time in the past or prior radiation therapy within the last 3 years to the breast / sternum, head, or neck
- Requires anti-folate therapy for the management of co-morbid conditions
- Known regular user (including "recreational use") of any illicit drugs or had a recent history (within the last year) of drug or alcohol abuse
- Pregnant or breastfeeding or expecting to conceive, or donate sperm within the span of the study
- Human Immunodeficiency Virus (HIV)-positive
- Active Hepatitis B or C
- Symptomatic ascites or pleural effusion.
- History of stem cell or bone marrow transplant
Exclusion Criteria for Part B:
- Permanent pacemaker
- Unable to refrain from use of all concomitant medications on Day 1
- Structural heart disease, history of myocardial infarction (MI), or unstable angina
- History of cardiac arrhythmia, congestive heart failure (CHF), sick sinus syndrome, second or third degree atrioventricular (AV) block
- History of risk factors for Torsades de Pointes such as CHF, uncorrected hypokalemia, family history of long QT syndrome
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Part A: Vintafolide BIW
Vintafolide, intravenously (IV), on Days 1, 4, 8, and 11 of each 21-day cycle.
Carboplatin, IV, at a dose of area under the curve (AUC)5, administered on Day 1 of each 21-day cycle.
Paclitaxel, IV, at a dose of 175 mg/m^2, administered on Day 1 of each 21-day cycle
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Outros nomes:
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Experimental: Part A: Vintafolide TIW
Vintafolide, intravenously (IV) on Days 1, 3, 5, 8, 10, and 12 of each 21-day cycle.
Carboplatin, IV, at a dose of area under the curve (AUC)5, administered on Day 1 of each 21-day cycle.
Paclitaxel, IV, at a dose of 175 mg/m^2, administered on Day 1 of each 21-day cycle
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Outros nomes:
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Experimental: Parts B & C: Vintafolide Single Dose & Weekly (QW)
Single dose, dose escalation, vintafolide (Part B) followed by 2 week observation.
Those completing Part B will have the option to continue on to Part C (weekly dosing, dose finding, on Days 1, 8, and 15 in a 21-day cycle until disease progression or toxicity) unless they experience severe and/or persistent drug related toxicity.
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Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
|---|---|
|
Parts A and C: Number of participants with dose-limiting toxicities (DLTs)
Prazo: Cycle 1 (21 days)
|
Cycle 1 (21 days)
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Part B: Change from Baseline in QTc interval
Prazo: 30 minutes pre-dose and up to 2 hours post-dose
|
30 minutes pre-dose and up to 2 hours post-dose
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Part C: Number of Participants Experiencing an Adverse Event (AE)
Prazo: Up to 18 weeks (six 3-week cycles)
|
Up to 18 weeks (six 3-week cycles)
|
Medidas de resultados secundários
Medida de resultado |
Prazo |
|---|---|
|
Number of participants whose best response is partial response (PR) or complete response (CR)
Prazo: Week 6
|
Week 6
|
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Progression free survival
Prazo: Week 6
|
Week 6
|
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Disease control rate
Prazo: Week 6
|
Week 6
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Part B: Pharmacokinetics (PK) of vintafolide, including Area Under the Curve (AUC) and Maximum Concentration (Cmax)
Prazo: Day 1
|
Day 1
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Part B: PK of Vintafolide Metabolites, including AUC and Cmax
Prazo: Day 1
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Day 1
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo
1 de dezembro de 2012
Conclusão Primária (Real)
1 de setembro de 2014
Conclusão do estudo (Real)
1 de setembro de 2014
Datas de inscrição no estudo
Enviado pela primeira vez
17 de setembro de 2012
Enviado pela primeira vez que atendeu aos critérios de CQ
17 de setembro de 2012
Primeira postagem (Estimativa)
20 de setembro de 2012
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
10 de fevereiro de 2015
Última atualização enviada que atendeu aos critérios de controle de qualidade
9 de fevereiro de 2015
Última verificação
1 de fevereiro de 2015
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 8109-001
- 2012-002799-14 (Número EudraCT)
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 .