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| Name | Class |
|---|---|
| M.D. Anderson Cancer Center | OTHER |
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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.
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:
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):
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.
Urine Collection:
Urine will be collected for PK testing at the following time points during Cycles 1 and 3:
Participants will collect their urine at home over 24 hours during the following times after they received the study drug:
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NC-4016 | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NC-4016 | Drug | Dose Escalation Group Starting Dose: 15 mg/m2 by vein on Day 1 of a 21 Day cycle. Dose Expansion Group Starting Dose: Maximum tolerated dose from Dose Escalation Group. |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Tolerated Dose (MTD) of NC-4016 | MTD defined as the highest dose level at which no more than 1 of 6 dose limiting toxicity (DLT) evaluable patients experience a DLT during Cycle 1 of dosing. DLT determined by NCI CTCAE v4.03, 14 June 2010. | 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | calculated for all patients using noncompartmental analysis | During the First 4 Cycles of Treatment (each cycle is 21 days) |
| Tmax | calculated for all patients using noncompartmental analysis |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| University of Texas MD Anderson Cancer Center Website | View source |
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| ID | Term |
|---|---|
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
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| ID | Term |
|---|---|
| C000627050 | NC-4016 |
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| During the First 4 Cycles of Treatment (each cycle is 21 days) |
| AUC | calculated for all patients using noncompartmental analysis | During the First 4 Cycles of Treatment (each cycle is 21 days) |
| T1/2 | calculated for all patients using noncompartmental analysis | During the First 4 Cycles of Treatment (each cycle is 21 days) |
| CL | calculated for all patients using noncompartmental analysis | During the First 4 Cycles of Treatment (each cycle is 21 days) |
| Vss | calculated for all patients using noncompartmental analysis | During the First 4 Cycles of Treatment (each cycle is 21 days) |
| Vz | calculated for all patients using noncompartmental analysis | During the First 4 Cycles of Treatment (each cycle is 21 days) |
| Excretion Profile of Total and Free (Ultrafiltrate) Platinum (Pt) | Cycle 1 and Cycle 3 (each cycle is 21 days) |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |