Collection of Pharmacokinetic Samples From People With Unanticipated Response, Significant Toxicity or Concern of Future Toxicity
Cancer · Solid Tumors · Neoplasm
De qué trata este estudio
El registro no identifica actualmente este estudio como reclutando. Consulta su estado antes de planificar una evaluación.
- Tipo de estudio
- Observacional
- Fase
- No aplica / no indicada
- Rango de edad
- 2 años - No especificado
- Sexo admitido
- Todos los sexos
- Voluntarios sanos
- Aceptados
- Participantes
- 100 Estimado
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Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.
Acerca de la investigación
Background:
\- Certain drugs - even when they are meant to help people - cause side effects. These are unwanted effects of the drug. There are many reasons why a drug might cause side effects in one person and not in another. It may be because of how much of the drug is in the person s blood at one time. Researchers want to study the blood of people having drug side effects to better understand why they happen.
Objective:
\- To obtain blood samples from participants being treated with an investigational or FDA approved drug at the NIH who are having or are anticipated to have bad side effects that are thought to be due to large amount of the drug in their blood. The samples will be used to assess the cause of the side effects.
Eligibility:
\- People 2 years and older who are currently enrolled in clinical trials at the NIH Intramural Research Program (IRP).
Design:
\- Participants will give blood samples.
Leer la descripción completa
Background:
- Pharmacology is the study of pharmaceutical compounds and encompasses several parameters, including how the body handles the substance (pharmacokinetics, PK), what the substance does to the body at the molecular level (pharmacodynamics), overall efficacy (response), and any adverse events or toxicity encountered.
- The Clinical Pharmacology Program (CPP) within the Center for Cancer Research (CCR) of the National Cancer Institute (NCI) has sensitive, state of the art bioanalytical instrumentation that can accurately and precisely quantitate drug concentrations in plasma.
- Currently, the CPP can only analyze samples from clinical trials that have explicit instructions (within the Pharmacokinetics section) to do so in the IRB approved protocol.
- However, clinical trial protocols without a Pharmacokinetics section may still need occasional pharmacokinetic plasma samples drawn and drug concentration measurements performed to help explain unexpected AEs or toxicity or anticipated altered pharmacokinetics.
- The administration of probe substrates can be used to determine the phenotype of enzymes and transporters responsible for drug disposition, providing a useful tool to better understand the cause of unexpected AEs or toxicities of clinical trial participants.
Objectives:
- Primary Objective: To assess PK samples/profiles from participants being treated with an investigational agent or FDA approved therapy at the NIH who are exhibiting or are anticipated to exhibit unusual response or toxicity that is believed to be due to high drug concentration in order to assess the cause of the toxicity and adverse events
- Exploratory Objective: To use phenotyping probes to research how individuals with genetic defects in drug metabolism genes might handle the probe, assessing blood concentrations to ascertain the rate of metabolism of enzymes and transporters
Eligibility:
\- Any participants who are currently enrolled in IRB approved NIH Intramural Research Program (IRP) clinical trials are eligible.
Design:
- The CPP will measure the drug plasma concentration (or send the sample out to a third party if the assay is commercially available).
- The CPP will measure the plasma concentration of enzyme or transporter phenotyping probe substrates (or send the sample out to a third party if the assay is commercially available) in select participants enrolled on clinical trials at the CCR.
- The accrual ceiling for this study is 100 participants. The anticipated accrual rate for this protocol is less than 10 participants per year, and based on the accrual ceiling, the duration of accrual and the total study duration is 10 years.
¿Quién podría participar?
La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.
- INCLUSION CRITERIA:
- Any individuals greater than or equal to 2 years of age who are currently enrolled in IRB approved NIH Intramural Research Program (IRP) clinical trials are eligible. (Exception: Participants \<18 years old will not be eligible for probe administration.)
- Ability of subject or a Legally Authorized Representative (LAR) to understand and the willingness to sign a written informed consent document.
- Individuals who have received or are anticipated to receive an investigational agent or FDA approved therapy at the NIH who meet one of the following criteria:
- Individuals in whom altered pharmacokinetics are anticipated to occur based on pharmacogenetics, history of toxicities with similar agents, drug interactions, or other patient-specific factors which may alter absorption, distribution, metabolism, or excretion.
OR,
\-- Individuals who are exhibiting unusual response or toxicity that is believed to be due to high drug concentration in order to assess the cause of toxicity and adverse events.
Población del estudio
Any participants greater than or equal to 2 years of age who are currently enrolled in IRB approved NIH Intramural Research Program (IRP) clinical trials are eligible.
Entiende la evaluación inicialTratamiento, grupos y participación
El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.
- Asignación
- No informado
- Enmascaramiento
- No informado
1
Participants who are currently enrolled in IRB approved NIH Intramural Research Program clinical trial
Qué evalúan los investigadores
Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.
Medidas principales
To obtain PK sample
Plazo: study completion
Measure drug concentrations in blood.
Revisa las tablas completas y sus limitaciones en el registro oficial.
Abrir resultados oficiales ↗Centros de investigación (1)
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1 centros
National Institutes of Health Clinical CenterBethesda, Maryland, United StatesEstado desconocido
Equipo y fechas
- Patrocinador principal
- National Cancer Institute (NCI)
- Inicio del estudio
- 31 jul 2014 Real
- Finalización primaria
- 1 may 2029 Estimado
- Finalización del estudio
- 1 may 2030 Estimado
- Primera publicación
- 3 jun 2014 Estimado
- Última actualización
- 10 nov 2026 Real
Contactos oficiales del estudio
No hay un contacto central indicado. Revisa los centros y el registro oficial.
Título oficial del estudio
Collection of Pharmacokinetic and Probe Substrate Samples From Participants With Unanticipated Response, Significant Toxicity or Concern of Future Toxicity
Consulta a Wellness Clinical Research
Tu mensaje va a WCR, incluso si otra organización realiza este estudio. WCR puede orientarte, pero podría no realizar este estudio, tener acceso a su equipo ni poder inscribirte.
Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.
Consultado: 12 nov 2026 · Última actualización del registro: 10 nov 2026