- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT00364195
Tesmilifene in Combination With Docetaxel in the Treatment of Metastatic Breast Cancer
A Pharmacokinetic Interaction and Safety and Efficacy Phase II, Open Label Study With a Safety Lead-in Evaluating Docetaxel Plus Tesmilifene (YMB1002) in Patients With Metastatic Breast Cancer Suitable for Treatment With Docetaxel
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Primary Objective:
1. To evaluate whether the co-administration of a fixed dose of tesmilifene (5.3 mg/kg) with a standard dose of docetaxel (100 mg/m2) alters the plasma pharmacokinetics of docetaxel compared to the pharmacokinetics of docetaxel when given alone.
Secondary Objectives:
- To correlate plasma tesmilifene levels during and following the infusion with the acute tesmilifene-related adverse events observed during and after the infusion.
- To collect safety information for tesmilifene when administered in combination with docetaxel.
- To evaluate response rate, duration of response and overall survival in metastatic breast cancer patients receiving docetaxel plus tesmilifene.
Tipo de estudo
Inscrição (Antecipado)
Estágio
- Fase 2
Contactos e Locais
Locais de estudo
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Belgrade, Sérvia
- Clinical Hospital Center Bezanijska Kosa
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Belgrade, Sérvia
- Institute for Oncology and Radiology of Serbia (IORS)
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Sremska Kamenica, Sérvia
- Institute of Oncology Sremska Kamenica
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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:
- Patients with documented histological/cytological proof of metastatic and/or recurrent breast cancer suitable for treatment with docetaxel
- Patients must have documented hormone receptor status (ER/PR) and Her-2 neu status determined either by Immunohistochemistry or FISH, within 21 days of randomisation, if possible, otherwise receptor status from patient history can be used, if determined from earlier biopsy/surgery. Patients may be randomised whilst results of hormone receptor status (ER/PR) and Her-2 neu status are pending from the laboratory.
- Radiological investigations must be conducted within 21 days prior to randomization. Exceptions will be made only for patients who have had NEGATIVE examinations with 35 days prior to randomisation.
- Presence of at least one uni-dimensional measurable lesion. 5. Disease free interval (DFI) less than or equal to 24 months (from the time of initial surgery to randomization date).
6. Previous hormone therapy, chemotherapy and radiation therapy allowed as defined in the protocol 7. Patients with an ECOG status of 0, 1 or 2. 8. Have a life expectancy of at least 6 months 9. Patients must be female and aged ≥ 18 years and ≤ 65 years 10. Patients must be willing and able to follow instructions and make all required study visits.
11. Patients must be willing and able to give written consent to participate in this study.
12. Patients must have adequate organ and marrow function as defined in the protocol.
13. All women of child-bearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity of 25 IU/L of BHCG) within 72 hours prior to randomization.
14. Patients must have a negative blood tests for HIV and Hepatitis B and C within 4 weeks prior to randomisation.
Exclusion Criteria:
- Patients with previous malignancies, excluding curatively treated basal or squamous cell carcinoma of the skin or in-situ cervical cancer or any other cancer treated more than five years prior to study entry and presumed cured.
- Patients with known brain or meningeal metastases (CT scan not required to rule this out unless there is a clinical suspicion of CNS disease).
- Patients whose only measurable disease is in the bone.
- Patients using chemotherapeutic agents for any malignancy within 4 weeks prior to study entry or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
- Patients who have received treatment with any other investigational drug within the preceding 4 weeks.
- Patient who have received hormone treatment for cancer within 6 weeks or 5 half-lives of enrolment (whichever is shorter).
- Pregnant and breast-feeding females.
- Patients with history of seizure disorder.
- Patients with clinically significant cardiovascular, pulmonary, renal, endocrine, hepatic, respiratory, neurologic, psychiatric, immunologic, gastrointestinal, haematologic, metabolic or any other condition or laboratory abnormality that, in the opinion of the Investigator or Medical Director of YM BioSciences Inc., makes the patient unsuitable for participation in the study.
- Known allergy or hypersensitivity to test article ingredients.
- Patients on COX 1 or 2 prostaglandin inhibitors (e.g. ASA, other NSAID's, Celebrex®, Vioxx® ) who can not comply with guidelines or concomitant therapy as outlined in appendix V, i.e.; avoid from midnight before treatment until midnight post treatment. Patients who are required to take low dose aspirin (81 mg) may be allowed to continue taking low dose aspirin.
- Patients on H1 antagonists (e.g., antihistamines, antidepressants or antiemetics) detailed in appendix V who can not comply with guidelines or concomitant therapy as outlined in appendix V, i.e.; avoid from 12 hours before the start of protocol treatment begins until the patient is off protocol treatment.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição cruzada
- Mascaramento: Nenhum (rótulo aberto)
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
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To evaluate whether the co-administration of a fixed dose of tesmilifene (5.3 mg/kg) with a standard dose of docetaxel (100 mg/m2) alters the plasma pharmacokinetics of docetaxel compared to the pharmacokinetics of docetaxel when given alone.
|
Medidas de resultados secundários
Medida de resultado |
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To correlate plasma tesmilifene levels during and following the infusion with the acute tesmilifene-related adverse events observed during and after the infusion.
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To collect safety information for tesmilifene when administered in combination with docetaxel.
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To evaluate response rate, duration of response and overall survival in metastatic breast cancer patients receiving docetaxel plus tesmilifene.
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Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
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
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- YMB1002 203
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 .
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