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A Phase 1 Dose-Escalation and Pharmacokinetic Study of NC-4016 in Patients With Advanced Solid Tumors or Lymphoma

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Qué se está evaluando

NC-4016

Medicamento
Quiénes están siendo reclutados

Enfermedades hemáticas y linfáticas+5

+ Enfermedades del sistema inmunitario

+ Trastornos Inmunoproliferativos

A partir de 18 años
+22 Criterios de eligibilidad
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Cómo está diseñado el estudio

Estudio de Tratamiento

Fase 1
Intervencional
Inicio del estudio: noviembre de 2013
Ver detalles del protocolo

Resumen

Patrocinador PrincipalNanoCarrier Co., Ltd.
Última actualización: 27 de enero de 2026
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Fecha de inicio: 1 de noviembre de 2013

Fecha en la que se inscribió al primer participante.

Study Groups: If participants are found to be eligible to take part in this study, they will be enrolled in either a dose escalation group or the dose expansion group. Dose Escalation: If participants are in a dose escalation group, they will be assigned to a dose level based on when they joined this study. Up to 6 dose levels of NC-4016 will be tested and at least 3 patients will be enrolled at each dose level. The first group of participants will receive the lowest dose level of NC-4016. Each new group will receive a higher dose of NC-4016 than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of NC-4016 is found. Dose Expansion: If participants are in the dose expansion group, they will receive NC-4016 at the highest dose that was tolerated in the escalation groups. Study Drug Administration: Each study cycle is 21 days. On Day 1 of each cycle, you will receive NC-4016 by vein over 2 hours. Participants will be given standard drugs to help decrease the risk of side effects. They may ask the study staff for information about how the drugs are given and their risks. If participants have a severe side effect, their dose of study drug may be delayed. Study Visits: On Day 1 of each cycle: * Participants will have a physical exam. * Their vital signs (blood pressure, heart rate, breathing rate, and temperature) will be monitored every 20 minutes during the infusion and 1 hour after the end of the infusion during Cycle 1 and right before and at the end of the infusion for all other cycles. * Blood (about 3 teaspoons) will be drawn for routine tests. * Participants will have a neurological exam and electromyogram. * Participants will have an EKG before the start of the infusion, at the end of the infusion, and 1 hour after the end of the infusion (Cycle 1 and 2 only). After Cycle 1, Participants will only have 1 EKG before dosing. On Days 8 and 15 of each cycle, blood (about 3 teaspoons) will be drawn for routine tests. On Day 2 of Cycle 1 participants will have an EKG corresponding to the 24 hour PK testing. Every 3 cycles (every 9 weeks): * Participants will have an x-ray, CT, MRI, or PET scan to check the status of the disease. * If participants have lymphoma, they will have a bone marrow biopsy to check the status of the disease. * Participants will have a nerve conduction evaluation. * If the doctor thinks it is needed, blood (about 1 teaspoon) will be drawn for tumor marker testing. PK Testing: Blood (about 1 teaspoon each time) will be drawn for pharmacokinetic (PK) testing. PK testing measures the amount of study drug in the body at different time points. * On Day 1 of Cycles 1 and 3, blood will be drawn before, then at 0.5, 1, and 2 hours during the infusion, and then 9 more times up to 12 hours after participants receive the study drug (13 draws total each day). * On Days 2, 3, 4, 6, 8, and 15 of Cycles 1 and 3, blood will be drawn 1 time after participants receive the study drug. * On Day 1 of Cycles 2 and Cycle 4, blood will be drawn 1 time before participants receive the study drug. Urine Collection: Urine will be collected for PK testing at the following time points during Cycles 1 and 3: * Before participants receive the study drug * 0-2 hours (during the infusion) * 2-4 hours after they received the study drug * 4-8 hours after they received the study drug * 8-12 hours after they received the study drug * 12-24 hours after they received the study drug Participants will collect their urine at home over 24 hours during the following times after they received the study drug: * Days 1-2 * Days 2-3 * Days 7-8 * Days 14-15 * Days 21-22 The study doctor will provide participants with urine collection bottles. Urine samples will contain a very small amount of platinum from the study drug. This is not considered to be a risk, but as a precaution, the urine collection containers should only be handled by participants, and the containers will be labeled as a "Bio-Hazard". If participants have a severe side effect, they may have extra tests until the side effects have gotten better. Length of Study: Participants may continue taking the study drug for as long as they are benefitting. Participants will be taken off study early if the disease gets worse, intolerable side effects occur, they develop new health problems, their doctor thinks that it is no longer in their best interest to receive the study drug, or if they are unable to follow study directions. Participants' participation on the study will be over after the end-of-dosing visit. End-of-Dosing Visit: Within 28 days after the last dose of NC-4016 participants will: * Have a physical exam. * Have a neurological exam and an electromyogram. * Have a chest x-ray. * Have an x-ray, CT scan, MRI scan, or PET scan, or a bone marrow biopsy if they have lymphoma, to check the status of the disease. * Blood (about 3 teaspoons) and urine will be collected for routine tests. * Have an EKG and an ECHO or MUGA. * If the doctor thinks it is needed, blood (about 1 teaspoon) will be drawn for tumor marker testing. This is an investigational study. NC-4016 is not commercially available or FDA approved. It is currently being used for research purposes only. The study doctor can explain how NC-4016 is designed to work. Up to 40 participants will be enrolled in this study. All will be enrolled at MD Anderson.

Título OficialA Phase 1 Dose-Escalation and Pharmacokinetic Study of NC-4016 in Patients With Advanced Solid Tumors or Lymphoma
Patrocinador PrincipalNanoCarrier Co., Ltd.
Última actualización: 27 de enero de 2026
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Protocolo

Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.
Detalles del Diseño

Se reclutarán 34 pacientes

Número total de participantes que el ensayo clínico espera reclutar.

Estudio de Tratamiento

Estos estudios prueban nuevas formas de tratar una enfermedad, condición o problema de salud. El objetivo es determinar si un nuevo medicamento, terapia o enfoque funciona mejor o tiene menos efectos secundarios que las opciones existentes.



Elegibilidad

Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.
Condiciones
Criterios

Cualquier sexo

Sexo biológico de los participantes elegibles para inscribirse.

A partir de 18 años

Rango de edades de los participantes que pueden unirse al estudio.

Voluntarios sanos no permitidos

Indica si personas sanas, sin la condición que se estudia, pueden participar.

Condiciones

Patología

Enfermedades hemáticas y linfáticasEnfermedades del sistema inmunitarioTrastornos InmunoproliferativosEnfermedades LinfáticasLinfomaTrastornos LinfoproliferativosNeoplasiasNeoplasias por tipo histológico

Criterios

11 criterios de inclusión requeridos para participar
Have signed written informed consent prior to the initiation of any study-specific procedures

Be a male or female 18 years or older

Have a histologically or cytologically confirmed diagnosis of advanced solid tumor or lymphoma, or primitive hepatocarcinoma with radiological diagnosis

Have advanced or metastatic disease refractory to standard curative or palliative therapy or contraindication to standard therapy

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11 criterios de exclusión impiden participar
Have peripheral neuropathy of Grade 3 or Grade 4 at screening, according to National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE)v4.03, 14 June 2010 scale; or TNSc score greater than 4

Have an interval from previous neurotoxic platinums of less than 6 months and/or from previous other neurotoxic drugs less than 3 months (eg, taxanes) unless reasonably recovered from all grades of neurotoxicity as judged by the investigator

Have a history of thrombocytopenia with complications including hemorrhage or bleeding >= Grade 2 using NCI CTCAE v4.03, 14 June 2010 that required medical intervention or any hemolytic condition or coagulation disorders that would make participation unsafe in the opinion of the investigator

Have unresolved toxicity from previous treatment or previous investigational agents; excluding alopecia. Clinical judgment by the investigator is allowed to determine if grade 1 fatigue at screening is residual toxicity from prior treatment or is a symptom of the patient's general condition or disease. The investigator and medical monitor will discuss the eligibility of patients with baseline toxicity

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Plan de Estudio

Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.
Grupos de Tratamiento
Objetivos del Estudio

Un solo grupo de intervención está designado en este estudio

0% de probabilidad de ser asignado al grupo placebo

Grupos de Tratamiento

Grupo I

Experimental
Dose Escalation Group: NC-4016 will be administered as 2-hour intravenous infusion once every 3 weeks. Initial dose level 15 mg/m2. The dose level of NC-4016 in subsequent cohorts determined by the toxicity profile of the previous cohort, and dose level increased to 25, 30, 40, 60, and 80 mg/m2 or higher at each subsequent cycle until the highest dose level is reached or DLT prohibits further dose-level escalation. Dose level 1 will be the starting dose level (DL). If 2 out of the first 3 patients enrolled at DL1 experience a DLT during Cycle 1 or Cycle 2,then the next cohort of patients will be enrolled at DL0 (10 mg/m2). Dose Expansion Group: Maximum tolerated dose from Dose Escalation Group

Objetivos del Estudio

Objetivos Primarios

Objetivos Secundarios

Centros del Estudio

Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.

Este estudio tiene una ubicación

Suspendido

University of Texas MD Anderson Cancer Center

Houston, United StatesAbrir University of Texas MD Anderson Cancer Center en Google Maps
Completado1 Centros de Estudio