- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02040558
Trial to Study the Safety of Intravenous MNK-010 in Advanced Solid Tumors
4 de abril de 2017 actualizado por: Mallinckrodt
A Multicenter, Open-Label, Phase 1 First in Human Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Intravenous MNK-010 in Subjects With Advanced Solid Tumors
This is a multicenter, open-label, dose escalation study of MNK-010 in subjects with advanced solid malignancies who have failed conventional therapy.
The safety, tolerability, pharmacokinetic (PK) profile, and preliminary antitumor activity of ascending doses of MNK-010 will be evaluated in subjects with advanced solid tumors.
Descripción general del estudio
Tipo de estudio
Intervencionista
Inscripción (Actual)
44
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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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02215
- Dana Farber Cancer Institute
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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:
- Diagnosis of an advanced solid tumor malignancy.
- Histological or cytological evidence of malignancy.
- Advanced malignancy, metastatic or unresectable, that has recurred or progressed following standard therapy or failed standard therapy; or for which no standard therapy currently exists, or for which subject is not a candidate for, or is unwilling to undergo, standard therapy.
- Disease that is currently not amenable to curative surgical intervention.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 and a life expectancy > 12 weeks.
- Subject (and/or parent/guardian for subject who otherwise is unable to provide independent consent, if acceptable to and approved by the site and/or site's IRB) must be willing to give written informed consent and be able to adhere to dose and visit schedules.
- 18 years or older, of either sex, and of any race
- Female subjects of childbearing potential must have negative pregnancy test within 7 days prior to first dose of study drug; practicing an acceptable form of birth control for greater than 2 months prior to screening and commits to use for the duration of the study and for 3 months following the last dose of study treatment.
- Male subjects must be sterile (biologically or surgically) or commit to the use of a reliable method of birth control for the duration of the study until at least 3 months after the last dose of study treatment in such a manner that the risk of pregnancy for a partner is minimized.
- Prior to study treatment administration, at least 21 days must have elapsed since the subject's prior investigational or non-investigational systemic therapy, or any major surgery, and at least 21 days since prior radiotherapy.
- Subjects with a history of prior radiotherapy are eligible if they meet the following parameters: Prior to study treatment administration, must be ≥ 21 days post-therapy and have recovered from all toxicities; must have evidence of measurable disease outside the radiation fields or radiologically confirmed progression of disease; must not have had > 25% of their functional bone marrow irradiated. Must have radiologically measureable disease, a life expectancy > 12 weeks, and adequate organ function.
Exclusion Criteria:
- Subject has received any chemotherapy, immunotherapy, vaccines, monoclonal antibodies, whether conventional or investigational, major surgery within 21 days, or radiotherapy within 21 days of treatment in this study, or at any time during the study.
- Subject has an active, uncontrolled systemic infection considered opportunistic, life-threatening, or clinically significant at the time of treatment.
- Subject has symptomatic or untreated central nervous system (CNS) metastases; any type of active seizure disorder; febrile neutropenia; ≥ Grade 2 peripheral neuropathy; peritoneal or pleural effusions requiring a tap more frequently than every 14 days; QT interval corrected (QTc) prolongation or a prior history of serious arrhythmias or significant abnormalities on screening ECG; previously experienced a severe reaction to a liposomal product or a taxane; received IV treatment for bacterial/fungal infection within 7 days of screening.
- Subject has known significant cardiovascular disease or cerebrovascular accident within 3 months of enrollment, or within the timeframe as stipulated in the additional criteria outlined in the protocol.
- Subject requires the use of the following concomitant treatments/procedures at any time, per protocol.
- Subject requires either moderate or strong (if weak, 2 or more) inhibitors or inducers of Cytochrome P450 3A (CYP3A) mediated metabolism.
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: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: MNK-010
Subjects will receive 1 dose of MNK-010 followed by a 7-day post dose assessment period per treatment cycle.
Dose levels will be based upon the amount of active delivered per square meter of body surface area (mg/m2).
Cycles will repeat every 3 weeks (21 days) based on toxicity and response, as determined by a Safety Review Committee (SRC).
Subjects will continue treatment with MNK-010 until unacceptable toxicity, documented progression of disease, another criterion for discontinuation is met, or until 4 treatment cycles have been completed.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Maximum tolerated dose (MTD)
Periodo de tiempo: 27 months
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MTD of MNK-010
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27 months
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Treatment-emergent adverse events (TEAEs)
Periodo de tiempo: 27 months
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Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), adverse events (AEs) of at least Grade 3 severity, and discontinuations due to AEs.
AEs will be evaluated and categorized in accordance with the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events
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27 months
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Clinical labs
Periodo de tiempo: 27 months
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Changes from baseline in clinical laboratory assessments, vital signs, arterial oxygen saturation (SaO2) by pulse oximetry, physical examination, and 12-lead electrocardiograms (ECGs)
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27 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Plasma PK
Periodo de tiempo: 27 months
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Standard plasma PK parameters will be measured following single and multiple doses.
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27 months
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Overall response
Periodo de tiempo: 27 months
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Best confirmed overall response based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
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27 months
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
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
1 de julio de 2013
Finalización primaria (Actual)
1 de mayo de 2016
Finalización del estudio (Actual)
1 de julio de 2016
Fechas de registro del estudio
Enviado por primera vez
13 de enero de 2014
Primero enviado que cumplió con los criterios de control de calidad
17 de enero de 2014
Publicado por primera vez (Estimar)
20 de enero de 2014
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
5 de abril de 2017
Última actualización enviada que cumplió con los criterios de control de calidad
4 de abril de 2017
Última verificación
1 de abril de 2017
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- COV10100386
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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