- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00177281
Safety Study of S-CKD602 in Patients With Advanced Malignancies
A Phase I Study to Evaluate the Safety and Pharmacokinetics of S-CKD602 in Patients With Advanced Malignancies
Descripción general del estudio
Descripción detallada
The main purposes of this study are:
To determine the maximum tolerated dose (highest dose that can safely be given to subjects) of S CKD602 when given every three weeks.
To determine the incidence and severity of toxicity (side-effects) of S CKD602 when given every three weeks.
To determine a subject's body handles the drug (pharmacokinetics) following administration of S CKD602.
In addition to the above, we would also like to analyze how the genes (material inside each cell that is responsible for cell functioning and appearance) found in a subject's blood affect how the study drug S-CKD602 is broken down in a subject's body. This process is referred to as "metabolic genotyping analyses". This evaluation is performed using a blood sample and is optional.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 1
Contactos y Ubicaciones
Ubicaciones de estudio
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Pennsylvania
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Pittsburgh, Pennsylvania, Estados Unidos, 15232
- University of Pittsburgh Medical Center
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
Male or female subjects with an age > 18 years Histologically or cytologically proven malignancy, unresponsive to curative surgery, radiotherapy, conventional chemotherapy or for which no conventional therapy exists. (Measurable or evaluable disease is desirable, but not required) Note: This study is restricted to patients with advanced solid tumors, subjects with hematological malignancies are excluded (including lymphoma and leukemia) ECOG Performance Status 0- 2 Adequate bone marrow function, without the support of cytokines and/or Epoetin Alpha within 5 days prior to dosing: Absolute neutrophil count (ANC) >1,500/mm3, platelet count > 100,000/mm3, Hgb > 9.0 g/dL. Adequate liver function: total bilirubin level < 2.0 mg/dL, ALT and AST < 2.0 x institutional upper limit of normal in the absence of liver metastasis, or < 4.0 x institutional upper limit of normal in the presence of liver metastasis.
Adequate renal function: serum creatinine < 1.5 mg/dL. At least 3 weeks since prior chemotherapy or cancer surgery (6 weeks for nitrosourea or mitomycin C).
Normal cardiac function with no history of uncontrolled heart disease. Women subjects (if of child bearing potential and sexually active) and male subjects (if sexually active with a partner of child bearing potential) must use medically acceptable methods of birth control prior to study entry and for the duration of the study. Medically acceptable methods of contraception that may be used by the subject and/or his/her partner include abstinence, birth control pills or patches, diaphragm and spermicide, IUD, condom and vaginal spermicide, surgical sterilization, post menopausal, vasectomy, and progestin implant or injection.
Written informed consent.
Exclusion Criteria:
Subject is pregnant or is breast feeding. Subject's life expectancy is less than 3 months. Subject exhibits confusion, disorientation, or has a history of major Psychiatric illness, which may potentially impair subject's understanding of the informed consent.
Subject has signs and symptoms of acute infection requiring systemic therapy. Subject has used another investigational agent within 30 days of dosing with S CKD602.
Subjects with known allergic reactions to camptothecin analogs, dextran sulfate or other components of S-CKD602 Symptomatic or uncontrolled brain leptomeningeal metastasis. CT scans are not required unless there is clinical suspicion of central nervous disease.
Not recovered from reversible toxicity of prior therapy. Subjects with known brain metastases because of their poor prognosis because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
Concurrent radiation therapy or radiation within 3 weeks of starting treatment with S-CKD602.
Concurrent anti-neoplastic agents.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
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To determine the maximum tolerated dose of S CKD602 when given every three weeks.
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To determine the incidence and severity of toxicity of S CKD602 when given every three weeks.
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Medidas de resultado secundarias
Medida de resultado |
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To determine the pharmacokinetics of CKD 602 following administration of S CKD602.
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Ramesh K Ramanathan, MD, University of Pittsburgh
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 03-052
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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