Ignite Creation Date:
2025-12-24 @ 10:12 PM
Ignite Modification Date:
2026-01-06 @ 9:40 PM
Study NCT ID:
NCT03168035
Status:
COMPLETED
Last Update Posted:
2018-02-23
First Post:
2017-04-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of NC-4016 in Patients With Advanced Solid Tumors or Lymphoma
Sponsor:
NanoCarrier Co., Ltd.
Organization:
Study Overview
Official Title:
A Phase 1 Dose-Escalation and Pharmacokinetic Study of NC-4016 in Patients With Advanced Solid Tumors or Lymphoma
Status:
COMPLETED
Status Verified Date:
2018-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical research study is to find the highest tolerated dose of NC-4016 that can be given to patients with advanced solid tumors or lymphoma. The safety of the drug will also be studied.
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: