Terminé

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

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Ce qui est testé

NC-4016

Médicament
Qui peut participer

Maladies hématologiques et lymphatiques+5

+ Maladies du Système Immunitaire

+ Troubles immunoprolifératifs

À partir de 18 ans
+22 critères d'éligibilité
Voir tous les critères d'éligibilité
Comment se déroule l'étude

Étude thérapeutique

Phase 1
Interventionnel
Date de début : novembre 2013
Voir le détail du protocole

Résumé

Sponsor principalNanoCarrier Co., Ltd.
Dernière mise à jour : 27 janvier 2026
Issu d'une base de données validée par les autorités. Revendiquer en tant que partenaire

Date de début de l'étude : 1 novembre 2013

Date à laquelle le premier participant a commencé l'étude.

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.

Titre officielA Phase 1 Dose-Escalation and Pharmacokinetic Study of NC-4016 in Patients With Advanced Solid Tumors or Lymphoma
Sponsor principalNanoCarrier Co., Ltd.
Dernière mise à jour : 27 janvier 2026
Issu d'une base de données validée par les autorités. Revendiquer en tant que partenaire

Protocole

Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.
Détails du design

34 participants à inclure

Nombre total de participants que l'essai clinique vise à recruter.

Traitement

Cette étude teste un ou plusieurs traitements pour évaluer leur efficacité contre une maladie ou un problème de santé spécifique. L'objectif est de voir si un nouveau médicament ou une thérapie fonctionne mieux, ou provoque moins d'effets secondaires que les options existantes.



Éligibilité

Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.
Conditions
Critères

Tout sexe

Le sexe biologique des participants éligibles à s'inscrire.

À partir de 18 ans

Tranche d'âge des participants éligibles à participer.

Volontaires sains non autorisés

Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.

Conditions

Pathologie

Maladies hématologiques et lymphatiquesMaladies du Système ImmunitaireTroubles immunoprolifératifsLymphomeMaladies lymphatiquesTroubles LymphoprolifératifsNéoplasmes par type histologiqueNéoplasmes

Critères

11 critères d'inclusion nécessaires pour participer
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

Voir plus de critères

11 critères d'exclusion empêchent la participation
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 l'étude

Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.
Groupes de traitement
Objectifs de l'étude

Un seul groupe d'intervention est désigné dans cette étude

Cette étude ne comporte pas de groupe placebo. 

Groupes de traitement

Groupe I

Expérimental
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

Objectifs de l'étude

Objectifs principaux

Objectifs secondaires

Centres d'étude

Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.

Cette étude comporte 1 site

Suspendu

University of Texas MD Anderson Cancer Center

Houston, United StatesOuvrir University of Texas MD Anderson Cancer Center dans Google Maps
Terminé1 Centres d'Étude