- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00695448
Phase I Open-Label, Dose-Escalation Study of GSK1059615 in Patients With Solid Tumors or Lymphoma
23 de julio de 2017 actualizado por: GlaxoSmithKline
A Phase I Open-Label, Dose-Escalation Study of the Phosphoinositide 3-Kinase Inhibitor GSK1059615 in Patients With Solid Tumors or Lymphoma
This is an open-label, multi-center Phase I study conducted to define the recommended Phase 2 dose, toxicity profile, pharmacokinetics and biologically active dose range of GSK1059615.
Descripción general del estudio
Tipo de estudio
Intervencionista
Inscripción (Actual)
11
Fase
- Fase 1
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Tennessee
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Nashville, Tennessee, Estados Unidos, 37203
- GSK Investigational Site
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Texas
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Houston, Texas, Estados Unidos, 77030-4009
- GSK Investigational Site
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Written informed consent provided.
- 18 years old or older.
- Histologically- or cytologically- confirmed diagnosis of solid tumor malignancy or lymphoma that is not responsive to accepted standard therapies or for which there is no standard or curative therapy.
- Performance Status score of 0 or 1 according to the Eastern Cooperative Oncology Group (ECOG) scale.
- A life expectancy of > 12 weeks.
- Able to swallow and retain oral medication.
- A male is eligible to enter and participate in the study if he either:
- agrees to abstain from sexual intercourse from the first dose of study drug and until 21 days after last dose of study medication, or
- agrees to use a condom and occlusive cap (diaphragm or cervical/vault cap) with spermicidal foam/gel/film/cream/suppository from the first dose of study drug and until 21 days after last dose of study medication, or
- is surgically sterile. NOTE: Male patients must use contraception to prevent pregnancy in a female partner and prevent exposure of any partner to semen by any means (refer to protocol).
- A female is eligible to enroll in the study if she is of:
Non-child bearing potential (i.e., physiologically incapable of becoming pregnant) including any woman who is characterized by at least one of the following:
- Has had a hysterectomy
- Has had a bilateral oophorectomy (ovariectomy)
- Has had a bilateral tubal ligation
- Is post-menopausal (total cessation of menses for ≥ 1 year) Childbearing potential, has a negative serum pregnancy test at screening, and agrees to one of the following from at least 2 weeks prior to the first dose of study drug and until 21 days after last dose of study medication:
- Use an intrauterine device (IUD) with a documented failure rate of
- less than 1% per year.
- Have intercourse only with a vasectomized partner who is sterile
- and is the sole sexual partner for that woman.
- Complete abstinence from sexual intercourse.
- Use double barrier contraception defined as condom with
- spermicidal jelly, foam, suppository, or film; OR diaphragm with
- spermicide; OR male condom and diaphragm. NOTE: Oral contraceptives are not reliable due to potential for drug-drug interaction.
- Adequate organ system function as defined in the protocol.
Exclusion Criteria:
- Use of an investigational anti-cancer drug within 28 days or 5 half-lives preceding the first dose of GSK1059615.
- Chemotherapy within the last 3 weeks (6 weeks for prior nitrosourea or mitomycin C). Chemotherapy regimens given continuously or on a weekly basis with limited potential for delayed toxicity are permitted with approval of the GSK medical monitor if administered at least 2 weeks prior to the first dose of study drug.
- Trastuzumab within the last 4 weeks.
- Any major surgery, radiotherapy, or immunotherapy within the last 4 weeks.
- Prior use of any PI3K inhibitor.
- Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to the study drug. (To date there are no known FDA approved drugs chemically related to GSK1059615).
- Current use of a prohibited medication or requires any of these medications during treatment with GSK1059615 as per protocol.
- Current use of warfarin for therapeutic anticoagulation.
- NOTE: Low molecular weight heparin and prophylactic low-dose warfarin are permitted. PT/PTT must meet the inclusion criteria. Patients taking warfarin must have their INR followed closely.
- Presence of an active gastrointestinal disease or other condition known to interfere significantly with the absorption, distribution, metabolism, or excretion of drugs.
- Unresolved toxicity greater than Grade 1 from previous anti-cancer therapy except alopecia. Patients with stable Grade 2 neuropathy can be enrolled with approval by the GSK Medical Monitor.
- QTc interval ≥ 480 msecs.
- History of acute coronary syndromes (including unstable angina and myocardial infarction), atrial fibrillation, coronary angioplasty, or stenting within the past 24 weeks.
- Class II, III, or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system.
- Symptomatic or untreated leptomeningeal or brain metastases. Patients previously treated for these conditions who are asymptomatic and off of corticosteroid and P450-inducing anti-epileptic medication for at least 2 months are permitted.
- Primary malignancy of the central nervous system.
- Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol.
- Concurrent condition that in the investigator's opinion would jeopardize compliance with the protocol.
- Nursing female.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: 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: Cohorts
The starting dose is 6mg once daily (QD); dose is to be escalated using a standard 3 + 3 dose escalation scheme.
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GSK1059615 is dosed orally once daily for 21 days of a 28-day cycle.
Patients continue treatment for subsequent cycles as long as eligible and receiving benefit.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
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Adverse events (AEs) and changes in laboratory values and vital signs as per protocol.
Periodo de tiempo: 21 days
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21 days
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
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Pharmacokinetic parameter values for GSK1059615 following single and repeated dosing, including area under the plasma drug concentration curve (AUC), maximum observed plasma drug concentration (Cmax)
Periodo de tiempo: 21 days
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21 days
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time to maximum observed plasma drug concentration, and half-life of GSK1059615.
Periodo de tiempo: 21 days
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21 days
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Metabolic profiling in plasma and urine, and amount excreted in urine (subset of patients).
Periodo de tiempo: 21 days
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21 days
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Tumor response as defined by RECIST in the protocol.
Periodo de tiempo: 56 days
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56 days
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Change from baseline in protein markers in tumor and/or blood.
Periodo de tiempo: 28 days
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28 days
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Blood glucose and insulin levels.
Periodo de tiempo: Daily for 28 days
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Daily for 28 days
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
24 de junio de 2008
Finalización primaria (Actual)
31 de marzo de 2009
Finalización del estudio (Actual)
31 de marzo de 2009
Fechas de registro del estudio
Enviado por primera vez
9 de junio de 2008
Primero enviado que cumplió con los criterios de control de calidad
9 de junio de 2008
Publicado por primera vez (Estimar)
11 de junio de 2008
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
25 de julio de 2017
Última actualización enviada que cumplió con los criterios de control de calidad
23 de julio de 2017
Última verificación
1 de julio de 2017
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- PIK111051
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Datos del estudio/Documentos
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Protocolo de estudio
Identificador de información: PIK111051Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
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Conjunto de datos de participantes individuales
Identificador de información: PIK111051Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
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Formulario de informe de caso anotado
Identificador de información: PIK111051Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
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Plan de Análisis Estadístico
Identificador de información: PIK111051Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
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Especificación del conjunto de datos
Identificador de información: PIK111051Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
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Informe de estudio clínico
Identificador de información: PIK111051Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
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Formulario de consentimiento informado
Identificador de información: PIK111051Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
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. .
Ensayos clínicos sobre Tumores Sólidos
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AstraZenecaReclutamientoAdv Solid Malig - H&N SCC, ATM Pro / Def NSCLC, cáncer gástrico, de mama y de ovarioEspaña, Estados Unidos, Bélgica, Reino Unido, Francia, Hungría, Canadá, Corea, república de, Australia