- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00874107
Efficacy/Safety of Imprime PGG® Injection With Bevacizumab and Paclitaxel/Carboplatin in Patients With Untreated Advanced Non-Small Cell Lung Cancer (NSCLC)
A Phase 2, Randomized, Efficacy and Safety Study of Imprime PGG® Injection in Combination With Bevacizumab and Concomitant Paclitaxel and Carboplatin Therapy in Patients With Previously Untreated Advanced (Stage IIIB or IV) Non-Small Cell Lung Cancer
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
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Halle/Saale, Alemania
- Hospital Marth-Maria Halle Dolau
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Kassel, Alemania
- Clinical Kassel GmbH
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Köln, Alemania
- Kliniken der Stadt Koln gGmbH
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Mainz, Alemania
- University of Mainz
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Munich, Alemania
- University of Munich
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Oldenburg, Alemania
- Pius-Hospital Oldenburg
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Ulm, Alemania, 89081
- Universitätsklinikum Ulm
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Arkansas
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Fayetteville, Arkansas, Estados Unidos, 72703
- Highlands Oncology Group
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Ohio
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Canton, Ohio, Estados Unidos, 44718
- Gabrail Cancer Center
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Texas
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San Antonio, Texas, Estados Unidos, 78229
- University of Texas Health Science Center, San Antonio
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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:
- Has read, understood and signed the informed consent form (ICF) approved by the Independent Review Board/Ethics Committee (IRB/EC);
- Is between the ages of 18 and 75 years old, inclusive;
- Has histologically or cytologically confirmed stage IIIB (malignant pericardial or pleural effusion) or stage IV non-small cell lung cancer;
- Has non-squamous, non-small cell lung cancer
- Has measurable disease, defined as at least one tumor that fulfills the criteria for a target lesion according to RECIST;
- Has an ECOG performance status of 0 or 1;
- Has a life expectancy of > 3 months;
Has adequate hematologic function as evidenced by:
- ANC ≥ 1,500/μL
- PLT ≥ 100,000/μL
- HGB ≥ 9 g/dL obtained within 1 week prior to the first dose of study medication;
Has adequate renal function as evidenced by:
- Serum creatinine ≤ 1.5 X the upper limit of normal (ULN) for the reference lab
- Urine dipstick for proteinuria of < 1+ (i.e., either 0 or trace) within 2 weeks of Day 1 If urine dipstick is ≥ 1+, then urine protein excretion must be ≤ 500 mg over a 24 hour collection obtained within 1 week prior to the first dose of study medication;
Has adequate hepatic function as evidenced by:
- Serum total bilirubin ≤ 1.0 mg/dL
- AST ≤ 2.5X ULN for the reference lab (≤ 5X ULN for subjects with known hepatic metastases)
- ALT ≤ 2.5X ULN for the reference lab (≤ 5X ULN for subjects with known hepatic metastases) obtained within 1 week prior to the first dose of study medication;
Has adequate coagulation function as evidenced by:
- INR ≤ 1.5
- PTT ≤ ULN for the reference lab obtained within 1 week prior to the first dose of study medication;
- If a woman of childbearing potential or a fertile man (and his partners), must agree to use an effective form of contraception (hormonal contraceptive, double-barrier method or abstinence) during the study.
Exclusion Criteria:
- Has received prior systemic chemotherapy at any time for lung cancer;
- Has received previous radiation therapy to >30% of active bone marrow or any radiation therapy within 3 weeks of Day 1;
- Has a known hypersensitivity to baker's yeast, or has an active yeast infection;
- Has had previous exposure to Betafectin® or Imprime PGG;
- Has an active infection;
Presents with any of the following medical diagnoses/conditions at the time of screening:
- Central nervous system (CNS) metastases
- Uncontrolled hypertension (>150/100 mmHg) or hypertension that requires > two agents for adequate control
- Peripheral neuropathy ≥ grade 2 from any cause
- Fever of >38.5° C within 3 days prior to screening or Day 1, initial dosing
- Known HIV/AIDs, Hepatitis B, Hepatitis C, connective tissue or autoimmune disease, or other clinical diagnosis, ongoing or intercurrent illness that in the physician's opinion could interfere with participation
Has a history of any of the following medical diagnoses/conditions:
- Arterial or venous thromboembolic or hemorrhagic disorders including stroke, transient ischemic attack or cerebral infarction
- Deep vein thrombosis within 1 year prior to screening
- Myocardial infarction or an unstable or uncontrolled disease or condition related to or impacting cardiac function (e.g., unstable angina, congestive heart failure) within the previous 6 months
- Second malignancy within the previous 5 years, other than basal cell carcinoma, cervical intra-epithelial neoplasia or curatively treated prostate cancer with a PSA of <2.0 ng/mL
- Has a known hypersensitivity to bevacizumab, murine proteins, or any component of bevacizumab;
- Has a know sensitivity to polyethoxylated castor oil;
- Has previously received treatment with bevacizumab;
- Has had surgery within 4 weeks of Day 1 or needle or open biopsy within 1 week of Day 1;
- Has a non-healing wound or gastric ulcer;
- Has a non-healed bone fracture;
- Is receiving systemic anti-coagulation therapy (e.g., dipyridalmole (Persantine®), ticlopidine (Ticlid®), clopidogrel (Plavix®) and /or cilostazol (Pletal®);
- Is receiving chronic daily treatment with aspirin (>100 mg/day) or other nonsteroidal anti-inflammatory agents known to inhibit platelet function within 1 week of Day 1;
Presents with any of the following medical diagnoses/conditions at the time of screening:
a. Predominant squamous cell histology
Has a history of any of the following medical diagnoses/conditions:
- Hemoptysis (≥ ½ tsp red blood)
- Bleeding diathesis or coagulopathy
- If female, is pregnant or breast-feeding;
- Is receiving concurrent investigational therapy or has received investigational therapy within a period of 30 days prior to the first scheduled day of dosing (investigational therapy is defined as treatment for which there is currently no regulatory-authority-approved indication);
- Has previously received an organ or progenitor/stem cell transplant.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: 1
Imprime PGG + bevacizumab + paclitaxel/carboplatin
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4 mg/kg, i.v. over 2 hr, weekly until progression or discontinuation
15 mg/kg, i.v., over 90 minutes, on Day 1 only of each 3-week treatment cycle
200 mg/m2, i.v. over 3 hr, on Day 2 of each 3-week treatment cycle for the first 4 to 6 treatment cycles.
AUC of 6 mg./mL · min based on the Calvert formula; i.v. over 30 min, on Day 2 of each 3-week treatment cycle for the first 4 to 6 treatment cycles
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Otro: 2
bevacizumab + paclitaxel/carboplatin
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15 mg/kg, i.v., over 90 minutes, on Day 1 only of each 3-week treatment cycle
200 mg/m2, i.v. over 3 hr, on Day 2 of each 3-week treatment cycle for the first 4 to 6 treatment cycles.
AUC of 6 mg./mL · min based on the Calvert formula; i.v. over 30 min, on Day 2 of each 3-week treatment cycle for the first 4 to 6 treatment cycles
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
To determine the objective response rate (ORR) in each study arm
Periodo de tiempo: Approximately 1.5 years
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Approximately 1.5 years
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
---|---|
To determine the disease control rate (DCR) in each study arm
Periodo de tiempo: Approximately 1.5 years
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Approximately 1.5 years
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To determine the complete response (CR), partial response (PR), and stable disease (SD) rates in each study arm
Periodo de tiempo: Approximately 1.5 years
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Approximately 1.5 years
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To determine the duration of objective tumor response in each study arm
Periodo de tiempo: Approximately 1.5 years
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Approximately 1.5 years
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To determine the duration of stable disease in each study arm
Periodo de tiempo: Approximately 1.5 years
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Approximately 1.5 years
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To determine the duration of time to progression (TTP) in each study arm
Periodo de tiempo: Approximately 1.5 years
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Approximately 1.5 years
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To assess the safety of the dosing regimen within each study arm
Periodo de tiempo: Approximately 1.5 years
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Approximately 1.5 years
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To determine the pharmacokinetic (PK) profile of Imprime PGG (in active treatment arm only)
Periodo de tiempo: Approximately 1.5 years
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Approximately 1.5 years
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Folker Schneller, MD, Klinikum Rechts der Isar der Technischen Universitaet Muenchen
Publicaciones y enlaces útiles
Publicaciones Generales
- Salvador C, Li B, Hansen R, Cramer DE, Kong M, Yan J. Yeast-derived beta-glucan augments the therapeutic efficacy mediated by anti-vascular endothelial growth factor monoclonal antibody in human carcinoma xenograft models. Clin Cancer Res. 2008 Feb 15;14(4):1239-47. doi: 10.1158/1078-0432.CCR-07-1669.
- Engel-Riedel W, Lowe J, Mattson P, Richard Trout J, Huhn RD, Gargano M, Patchen ML, Walsh R, Trinh MM, Dupuis M, Schneller F. A randomized, controlled trial evaluating the efficacy and safety of BTH1677 in combination with bevacizumab, carboplatin, and paclitaxel in first-line treatment of advanced non-small cell lung cancer. J Immunother Cancer. 2018 Feb 27;6(1):16. doi: 10.1186/s40425-018-0324-z.
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
- Enfermedades de las vías respiratorias
- Neoplasias
- Enfermedades pulmonares
- Neoplasias por sitio
- Neoplasias de las vías respiratorias
- Neoplasias torácicas
- Carcinoma Broncogénico
- Neoplasias Bronquiales
- Neoplasias Pulmonares
- Carcinoma de pulmón de células no pequeñas
- Efectos fisiológicos de las drogas
- Mecanismos moleculares de acción farmacológica
- Agentes antineoplásicos
- Moduladores de tubulina
- Agentes antimitóticos
- Moduladores de mitosis
- Agentes antineoplásicos, fitogénicos
- Agentes antineoplásicos inmunológicos
- Inhibidores de la angiogénesis
- Agentes moduladores de la angiogénesis
- Sustancias de crecimiento
- Inhibidores del crecimiento
- Carboplatino
- Paclitaxel
- Bevacizumab
Otros números de identificación del estudio
- BT-CL-PGG-LCA0821
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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