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

Lymphoma Clinical Trial

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

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial Description

Study Groups:

If you are found to be eligible to take part in this study, you will be enrolled in either a dose escalation group or the dose expansion group.

Dose Escalation:

If you are in a dose escalation group, you will be assigned to a dose level based on when you 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 you are in the dose expansion group, you 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.

You will be given standard drugs to help decrease the risk of side effects. You may ask the study staff for information about how the drugs are given and their risks.

If you have a severe side effect, your dose of study drug may be delayed.

Study Visits:

On Day 1 of each cycle:

• You will have a physical exam.

• Your 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.

• You will have a neurological exam and electromyogram.

• You 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, you 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 you will have an EKG corresponding to the 24 hour PK testing.

Every 3 cycles (every 9 weeks):

• You will have an x-ray, CT, MRI, or PET scan to check the status of the disease.

• If you have lymphoma, you will have a bone marrow biopsy to check the status of the disease.

• You 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 you 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 you receive the study drug.

• On Day 1 of Cycles 2 and Cycle 4, blood will be drawn 1 time before you receive the study drug.

Urine Collection:

Urine will be collected for PK testing at the following time points during Cycles 1 and 3:

• Before you receive the study drug

• 0-2 hours (during the infusion)

• 2-4 hours after you received the study drug

• 4-8 hours after you received the study drug

• 8-12 hours after you received the study drug

• 12-24 hours after you received the study drug

You will collect your urine at home over 24 hours during the following times after you received the study drug:

• Days 1-2

• Days 2-3

• Days 7-8

• Days 14-15

• Days 21-22

Your study doctor will provide you with urine collection bottles. Your urine samples will contain a very small amount of platinum from the study drug. This is not considered to be a risk to you, but as a precaution, the urine collection containers should only be handled by you, and the containers will be labeled as a "Bio-Hazard".

If you have a severe side effect, you may have extra tests until the side effects have gotten better.

Length of Study:

You may continue taking the study drug for as long as you are benefitting. You will be taken off study early if the disease gets worse, intolerable side effects occur, you develop new health problems, your doctor thinks that it is no longer in your best interest to receive the study drug, or if you are unable to follow study directions.

Your 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:

• You will have a physical exam.

• You will have a neurological exam and an electromyogram.

• You will have a chest x-ray.

• You will have an x-ray, CT scan, MRI scan, or PET scan, or a bone marrow biopsy if you have lymphoma, to check the status of the disease.

• Blood (about 3 teaspoons) and urine will be collected for routine tests.

• You will 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. ;

Related Conditions & MeSH terms

• Advanced Cancers
• Lymphoma

• NCT number: NCT01999491
• Study type: Interventional
• Source: M.D. Anderson Cancer Center
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: November 4, 2013
• Completion date: November 2018