- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT00496600
Phase I Study of Patupilone and RAD001
Phase I Study of Patupilone and RAD001 in Patients With Refractory Solid Tumor Malignancy
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Primary Endpoint To identify the maximum tolerated doses (MTD) of the combination of patupilone and RAD001
Secondary Endpoints To assess the toxicity of patupilone and RAD001 To determine if concentrations of RAD001 are elevated in the presence of patupilone To evaluate tumor response using standard imaging modalities (CT scan, x-ray, bone scan) To develop pharmacodynamic markers that may predict or indicate response to mTOR inhibition or patupilone treatment.
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 1
Contactos e Locais
Locais de estudo
-
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New Jersey
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New Brunswick, New Jersey, Estados Unidos, 08901
- The Cancer Institute of New Jersey
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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:
- All patients must have malignancy refractory to standard therapy or for whom no standard, effective therapy is available.
- Patient must have performance status 0-2 on the ECOG Performance Status (see Appendix B)
- Patient's disease must be measurable (RECIST) or evaluable (e.g., cytologically or radiologically detectable disease such as ascites, peritoneal deposits, or lesions which do not fulfill RECIST criteria for measurable disease).
- Patients must have intact intestinal absorption
- Patients must have adequate organ function
- Patient must have recovered from toxicity of prior chemotherapy and/or radiotherapy. Patient may not have received chemotherapy in the prior 4 weeks. Patients may have not received radiotherapy in the prior 3 weeks.
- Patient (male or female) must be ≥ 18 years old.
- Women must not be pregnant or lactating. Female patients of childbearing potential must have a negative pregnancy test within 7 days before initiation of study drug dosing. Post menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential. Male and female patients of reproductive potential must agree to employ an effective barrier method of birth control throughout the study, and for three months following discontinuation of study drug.
- Signed written informed consent.
Exclusion Criteria:
- Patient has received greater than 3 prior cytotoxic regimens for metastatic disease.
- Prior therapy with epothilones, rapamycin, rapamycin analogs, or known sensitivity to these agents
- Prior treatment with any investigational drug within the preceding 4 weeks.
- Patient has history of bone marrow or stem cell transplant.
- Patient has received prior radiation therapy to greater than 25% of the bone marrow.
- Patients has newly diagnosed, not yet treated or uncontrolled brain metastases or leptomeningeal disease.
- Patient has known hypersensitivity to the components of study drugs or its analogs.
- Patient with known Grade 3 or 4 hypersensitivity to macrolide antibiotics (eg. clarithromycin, erythromycin, azithromycin).
- Patient with any active (acute or chronic) or uncontrolled infection requiring systemic therapy.
- Patients with chronic treatment with systemic steroids or another immunosuppressive agent
- Patient with known HIV infection.
- Patients with unresolved diarrhea within the last 7 days prior to start of treatment.
- Concomitant treatment with medications that are listed as clinically relevant inducers or inhibitors of cytochrome P450 (CYP3A).
- Patients taking Coumadin® or other agents containing warfarin, with the exception of low dose Coumadin® (1 mg or less) administered prophylactically for maintenance of in-dwelling lines or ports
- Herbal preparations or related over-the-counter preparations containing herbal ingredients (eg. St. John's Wort)
- Any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study such as: unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction ≤ 6 months prior to first study treatment, serious uncontrolled cardiac arrhythmia, or severely impaired lung function
- Any patient with uncontrolled diabetes as defined by fasting serum glucose >1.5 x ULN
- Any patient with nonmalignant medical illnesses that are uncontrolled or whose control may be jeopardized by the treatment with the study therapy
- Patients with liver disease such as cirrhosis, chronic active hepatitis, or chronic persistent hepatitis
- Patients receiving immunization with attenuated live vaccines during study participation.
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)
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
---|---|
To identify the maximum tolerated doses (MTD) of the combination of patupilone and RAD001
Prazo: 3 years
|
3 years
|
Medidas de resultados secundários
Medida de resultado |
Prazo |
---|---|
find toxicity of patupilone and RAD001, see if concentrations of RAD001 are elevated with patupilone, evaluate tumor response using standard imaging, develop pharmacodynamic markers that may predict/indicate response to mTOR inhibition or patupilone trt
Prazo: 3 years
|
3 years
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Mark Stein, MD, Rutgers, The State University of New Jersey
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
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 050612
- CRAD001US16
- 0220060307 (Outro identificador: CINJ IRB)
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