- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00445198
A Phase 1/2a Study of ABT-263 in Subjects With Small Cell Lung Cancer (SCLC) or Other Non-Hematological Malignancies
A Phase 1/2a Study Evaluating the Safety, Pharmacokinetics, and Efficacy of ABT-263 in Subjects With Small Cell Lung Cancer or Other Non-Hematological Malignancies
Descripción general del estudio
Estado
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 2
- Fase 1
Contactos y Ubicaciones
Ubicaciones de estudio
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Edmonton, Canadá, T6G 1Z2
- Site Reference ID/Investigator# 7493
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Ottawa, Canadá, K1H 8L6
- Site Reference ID/Investigator# 7635
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Arizona
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Peoria, Arizona, Estados Unidos, 85381
- Site Reference ID/Investigator# 13605
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Phoenix, Arizona, Estados Unidos, 85013
- Site Reference ID/Investigator# 5261
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California
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Los Angeles, California, Estados Unidos, 90095-7187
- Site Reference ID/Investigator# 11942
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Sacramento, California, Estados Unidos, 95817
- Site Reference ID/Investigator# 4718
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Colorado
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Aurora, Colorado, Estados Unidos, 80045-0510
- Site Reference ID/Investigator# 3755
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Georgia
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Atlanta, Georgia, Estados Unidos, 30322
- Site Reference ID/Investigator# 8324
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Illinois
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Chicago, Illinois, Estados Unidos, 60612
- Site Reference ID/Investigator# 2623
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Maryland
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Baltimore, Maryland, Estados Unidos, 21231-1000
- Site Reference ID/Investigator# 2625
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Bethesda, Maryland, Estados Unidos, 20892
- Site Reference ID/Investigator# 12343
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02215
- Site Reference ID/Investigator# 11941
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Boston, Massachusetts, Estados Unidos, 02215
- Site Reference ID/Investigator# 2626
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North Carolina
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Charlotte, North Carolina, Estados Unidos, 28204
- Site Reference ID/Investigator# 4934
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Tennessee
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Nashville, Tennessee, Estados Unidos, 37203
- Site Reference ID/Investigator# 2624
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Washington
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Tacoma, Washington, Estados Unidos, 98405
- Site Reference ID/Investigator# 6650
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Leicester, Reino Unido, LE1 5WW
- Site Reference ID/Investigator# 18541
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Manchester, Reino Unido, M20 4BX
- Site Reference ID/Investigator# 2622
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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:
- The subject must be >=18 years of age.(Phase 1 & 2a)
- Histologically and/or cytologically documented diagnosis of small cell lung cancer (North America & UK) or other non-hematological malignancy (North America only).(Phase 1 only)
- Histologically and/or cytologically documented diagnosis of SCLC.(Phase 2a)
- At least one prior chemotherapy treatment regimen(s) and their disease is refractory or experienced progressive disease following the treatment.(Phase 1)
- Extensive-stage SCLC & is chemotherapy naïve(US only) has experienced progressive disease following at least one chemotherapy regimen or their disease is refractory.(Phase 2a)
- Brain metastases with clinically controlled neurologic symptoms, defined as surgical excision and/or radiation therapy followed by 21 days of stable neurologic function & no evidence of CNS disease progression as determined by CT or MRI within 21 days prior to the first dose of study drug.
- ECOG performance score <= 2(Ph 1) <=1(Phase 2a)
- Must be receiving a stable dose of Selective Serotonin Reuptake Inhibitor (SSRI) anti-depressants 21 days prior to 1st dose of study drug.
Adequate bone marrow, renal & hepatic function per local lab reference range at Screening as follows:
- Bone marrow: Absolute Neutrophil count (ANC)>=1000/µL
- Platelets>= 100,000/mm3
- Hemoglobin>=9.0g/dL
- Renal function: Serum creatinine<= 2.0mg/dL or calculated creatinine clearance>=50mL/min
- Hepatic function&enzymes: AST and ALT<=3.0 x the upper normal limit(ULN) of institution's normal range
- Bilirubin<=1.5xULN. If Gilbert's Syndrome may have Bilirubin> 1.5 x ULN
- Coagulation: aPTT and PT<=1.2 x the upper limit of normal
- Should have archived diagnostic tissue available for assessment of Bcl-2 family protein expression.(Phase 2a)
- All female subjects not surgically sterile or postmenopausal(for at least 1 year)and non-vasectomized male subject must practice at least one method of birth control.
Exclusion Criteria:
- Underlying or predisposing condition of bleeding or currently exhibits signs of bleeding.
- Recent history of non-chemotherapy induced thrombocytopenia associated bleeding within 1 year prior to first dose of study drug.
- Active peptic ulcer disease or other potentially hemorrhagic esophagitis/gastritis.
- The subject has active immune thrombocytopenic purpura (ITP),active autoimmune hemolytic anemia (AIHA), or a history of being refractory to platelet transfusions (within 1 year prior to the first dose of study drug).
- Currently receiving or requires anticoagulation therapy or any drug or herbal supplements that affect platelet function, with exception of low-dose anticoagulation medications that are used to maintain the patency of a central intravenous catheter.
- Received any anti-cancer therapy including chemotherapy, immunotherapy, radiotherapy, hormonal (with the exception of hormones for hypothyroidism or estrogen replacement therapy (ERT), anti estrogen analogs, agonists required to suppress serum testosterone levels), or any investigational therapy within 14 days prior to the first dose of study drug, or has not recovered to less than a grade 2 adverse effect(s) of the previous therapy.
- Received a biologic (G-CSF, GM-CSF or erythropoietin) within 28 days prior to the first dose of study drug.
- Steroid therapy for anti-neoplastic intent within seven days prior to the first dose of study drug.
- Has consumed grapefruit or grapefruit products within 3 days prior to the first dose of study drug.
- Significant history of cardiovascular disease, renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, or hepatic disease that in the opinion of the investigator would adversely affect his/her participating in this study.
- Positive for HIV
A history of other active malignancies within the past 3 years prior to screening, with the exception of:
- Adequately treated in situ carcinoma of the cervix uteri
- Basal or squamous cell carcinoma of the skin
- Previous malignancy confined and surgically resected with curative intent
Evidence of other clinically significant uncontrolled condition(s) including, but not limited to:
- Active systemic fungal infection
- Diagnosis of fever and neutropenia within 1 week prior to study drug administration.
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)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Phase 1 and Phase 2a
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Phase 1 dosing under two different schedules: 14 days on drug, 7 days off or continuous dosing. - 50 patients with SCLC and non-hematologic malignancies. Enrollment is closed in this arm of the study. Phase 2a dosing under two different schedules: 14 days on drug, 7 days off or continuous dosing. - 40 patients with SCLC |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
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Safety assessment
Periodo de tiempo: Repeating sequence of 14 days on therapy and 7 days off or continuous dosing
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Repeating sequence of 14 days on therapy and 7 days off or continuous dosing
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Dose limiting toxicity determination
Periodo de tiempo: Repeating sequence of 14 days on therapy and 7 days off or continuous dosing
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Repeating sequence of 14 days on therapy and 7 days off or continuous dosing
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Maximum tolerated dose determination
Periodo de tiempo: Repeating sequence of 14 days on therapy and 7 days off or continuous dosing
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Repeating sequence of 14 days on therapy and 7 days off or continuous dosing
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Pharmacokinetic profile evaluation
Periodo de tiempo: Repeating sequence of 14 days on therapy and 7 days off or continuous dosing
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Repeating sequence of 14 days on therapy and 7 days off or continuous dosing
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
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Extended safety assessment at the recommended Phase 2 dose
Periodo de tiempo: Repeating sequence of 14 days on therapy and 7 days off or continuous dosing
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Repeating sequence of 14 days on therapy and 7 days off or continuous dosing
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Preliminary efficacy assessment
Periodo de tiempo: Repeating sequence of 14 days on therapy and 7 days off or continuous dosing
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Repeating sequence of 14 days on therapy and 7 days off or continuous dosing
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Publicaciones y enlaces útiles
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 (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- M06-822
- 2006-003298-28 (Número EudraCT)
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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