Ignite Creation Date:
2025-12-24 @ 5:40 PM
Ignite Modification Date:
2026-04-11 @ 1:06 AM
Study NCT ID:
NCT00554268
Status:
COMPLETED
Last Update Posted:
2016-02-19
First Post:
2007-11-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trial of PBI-05204 in Advanced Cancer Patients
Sponsor:
M.D. Anderson Cancer Center
Organization:
Study Overview
Official Title:
An Open Label Phase I Trial of PBI-05204 in Advanced Cancer Patients
Status:
COMPLETED
Status Verified Date:
2013-04
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 safe dose of PBI-05204 that can be given to patients with advanced solid tumors. The study will also look at how PBI-05204 is processed by the body, how it leaves the body, how it affects the body, and if it is affecting certain proteins in the cancer cells.
Detailed Description:
The Study Drug PBI-05204, made from the oleander plant, is designed to prevent the growth of cancer cells by affecting proteins that lead to cell death.
Screening Tests
Before you can begin receiving the study drug, you will have "screening tests" to help the doctor decide if you are eligible to take part in this study. The following tests will be performed:
* You will have a physical exam, including measurement of vital signs (blood pressure, heart rate, temperature, and breathing rate), height, and weight.
* You will be asked how well you are able to perform the normal activities of daily living (performance status evaluation).
* Your complete medical history will be recorded.
* You will have an electrocardiogram (ECG -- a test that measures the electrical activity of the heart).
* You may have an echocardiogram (a picture of your heart using sound waves), if applicable.
* You will have a computed tomography (CT) scan or magnetic resonance imaging (MRI) to check the status of the disease.
* Blood (about 3-4 teaspoons) and urine will be collected for routine tests.
* Women who are able to have children must have a negative blood (about 2 teaspoons) or urine pregnancy test.
Study Drug Dose Level:
If you are found to be eligible to take part in this study, the amount of PBI-05204 that you take will be based on how many participants have been enrolled before you, and on the safety information that is available. There may be up to 6 participants enrolled in each group. The first group of participants enrolled on this study will receive PBI-05204 at the lowest dose level. If no intolerable side effects are experienced, the next group of participants will take a higher dose level. This process will continue until researchers find the highest dose of PBI-05204 that can be given without intolerable side effects occurring.
Study Drug Administration:
Depending on which group you are enrolled in, you will take the PBI-05204 capsules by mouth every day at the same time or twice a day (every 12 hours). Your Doctor will tell you which schedule you are on. You will take the drug on Days 1-21. On Days 22-28 you will take no study drug. Each 28 days is called a "study cycle".
Study Visits:
At the Predose Visit, 1-7 days before Day 1 of Cycle 1 you will have the following tests and procedures performed:
* You will have a physical exam, including measurement of your vital signs, height, and weight.
* You will have a performance status evaluation.
* Urine will be collected for routine tests.
* You will have an ECG, if applicable
* You will have your heart rate monitored by a Holter monitor. A Holter monitor is a machine that continuously records the heart's rhythms. Electrodes (small conducting patches) are stuck onto your chest and attached to a small recording monitor. You carry the Holter monitor in a pocket or in a small pouch worn around your neck or waist. The monitor is battery operated. After 24 hours, you return the monitor to the study doctor. The study doctor will look at the records and see if there have been any irregular heart rhythms.
* Blood (about 3-4 teaspoons) will be collected for routine tests.
* Women who are able to have children will have a blood (about 2 teaspoons) or urine pregnancy test.
On Day 1 Cycle 1 you will have the following tests and procedures performed:
* You will have a physical exam, including measurement of your vital signs.
* You will have a performance status evaluation.
* You will have an ECG. The ECG will be repeated on Day 1 of every later Cycle.
* Blood (about 3-4 teaspoons) and urine will be collected for routine tests.
* You will take your dose of PBI-05204 by mouth.
* Blood (about 2 teaspoons each time) will be collected for PK testing before you take the first daily dose of the study drug and then 1, 2, 4, 6, and 8 hours later.
* Blood (about 6 teaspoons) will be collected for pharmacodynamic (PD) testing before you take the study drug. PD testing is used to look at how the level of study drug in your body may affect the disease.
On Day 2 of Cycle 1 you will have the following:
* You will take your dose of PBI-05204 by mouth
* You will have an ECG.
On Day 7 of Cycle 1 you will have the following:
* Blood (about 6 teaspoons) will be drawn for PD testing.
* You will take your dose of PBI-05204 by mouth.
* You will have your heart rate monitored by a Holter monitor.
On Day 8 of Cycle 1 you will have the following tests and procedures performed:
* You will have a physical exam, including measurement of your vital signs.
* You will have a performance status evaluation.
* Blood (about 3-4 teaspoons) and urine will be collected for routine tests.
* You will take your dose of PBI-05204 by mouth.
* Blood (about 2 teaspoons each time) will be collected for PK testing before you take the first daily dose of the study drug and then 1, 2, 4, 6, and 8 hours later. Additional blood (about 2 teaspoons each time) will also be collected for PK testing before you take the second daily dose of the study drug and then 1, 2, 4, and 12 hours later.
* You will have an ECG.
On Day 15 of Cycle 1 you will have the following tests and procedures performed:
* You will have a physical exam, including measurement of your vital signs.
* You will have a performance status evaluation.
* You will have an ECG.
* Blood (about 3-4 teaspoons) and urine will be collected for routine tests.
* You will take your dose of PBI-05204 by mouth.
* Blood (about 2 teaspoons each time) will be collected for PK testing before you take the first daily dose of the study drug and then 1, 2, 4, 6, and 8 hours later.
On Day 21 of Cycle 1 you will have the following tests and procedures performed:
* You will have a physical exam, including measurement of your vital signs.
* You will have a performance status evaluation.
* Blood (about 3-4 teaspoons) and urine will be collected for routine tests.
* You will take your dose of PBI-05204 by mouth.
* Blood (about 2 teaspoons each time) will be collected for PK testing before you take the first daily dose of the study drug and then 1, 2, 4, 6, and 8 hours later. Additional blood (about 2 teaspoons each time) will also be collected for PK testing before you take the second daily dose of the study drug and then 1, 2, 4, and 12 hours later.
* Blood (about 6 teaspoons) will be collected for PD testing.
During the last week of Cycle 2, the following tests and procedures will be performed:
* You will have a physical exam, including measurement of your vital signs, height and weight.
* You will have a performance status evaluation.
* Blood (about 3-4 teaspoons) and urine will be collected for routine tests.
* You will have a CT or MRI scan to check the status of the disease.
* Women who are able to have children will have a blood (about 2 teaspoons) or urine pregnancy test.
On Day 1 of Cycles 3 and beyond you will have a physical exam, including measurement of your vital signs.
At the end of every 2 cycles beginning with Cycle 4 (Cycles 4, 6, 8, and so on) blood (about 3-4 teaspoons) and urine will be collected for routine tests. You will have a CT or MRI.
If you are enrolled in the expansion group, blood (about 2 teaspoons each time) will be collected for PK testing before you take the daily dose of the study drug and then 1, 2, 4, 6, 8 and 24 hours later on Day 1 of Cycle 1. On Days 8, 15 and 21 of Cycle 1, blood (about 2 teaspoons each time) will also be collected for PK testing before you take the daily dose of the study drug and then 1, 2, 4, 6 and 8 hours later.
If you are enrolled in the expansion group, you will also have two mandatory tumor biopsies collected within 1- 7 days before you take your daily dose of the study drug and once during Days 15-21 of Cycle 1. To collect the biopsy, your doctor will insert a needle into the tumor and withdraw a small piece of the tumor. The tumor tissue will be studied to look at special "markers" in the tumor that may help researchers predict who may benefit from the study drug.
Length of Study:
You will remain on study until the disease gets worse, you decide to come off study, your doctor decides it is in your best interest to come off the study, you have intolerable side effects, or the sponsor closes the study.
If you decided to leave the study early you must tell the study doctor in writing and return any unused study drug. You must complete the end-of-study visit.
End-of-Study Visit:
Once you are off-study, you will have an end-of-study visit within 30 days after the last dose of PBI-05204. At this visit, the following tests and procedures will be performed:
* You will have a physical exam, including a measurement of your vital signs.
* You will have a performance status evaluation.
* You will have an ECG.
* You will have your heart rate monitored by a Holter monitor.
* Blood (about 3-4 teaspoons) and urine will be collected for routine tests
* You will have a CT/MRI scan to assess your tumors.
* Women who are able to have children must have a blood (about 2 teaspoons) or urine pregnancy test.
Long-Term Follow-up:
After you complete the end-of-study visit, your study doctor will continue to contact you or your family doctor for a minimum of 30 days. You may be contacted by a phone call (less than 5 minutes), and you will be asked about your general health.
This is an investigational study. PBI-05204 is not FDA approved or commercially available. At this time, PBI-05204 is only being used in research. Up to 52 patients will take part in this study. All will be enrolled at M. D. Anderson.
Screening Tests
Before you can begin receiving the study drug, you will have "screening tests" to help the doctor decide if you are eligible to take part in this study. The following tests will be performed:
* You will have a physical exam, including measurement of vital signs (blood pressure, heart rate, temperature, and breathing rate), height, and weight.
* You will be asked how well you are able to perform the normal activities of daily living (performance status evaluation).
* Your complete medical history will be recorded.
* You will have an electrocardiogram (ECG -- a test that measures the electrical activity of the heart).
* You may have an echocardiogram (a picture of your heart using sound waves), if applicable.
* You will have a computed tomography (CT) scan or magnetic resonance imaging (MRI) to check the status of the disease.
* Blood (about 3-4 teaspoons) and urine will be collected for routine tests.
* Women who are able to have children must have a negative blood (about 2 teaspoons) or urine pregnancy test.
Study Drug Dose Level:
If you are found to be eligible to take part in this study, the amount of PBI-05204 that you take will be based on how many participants have been enrolled before you, and on the safety information that is available. There may be up to 6 participants enrolled in each group. The first group of participants enrolled on this study will receive PBI-05204 at the lowest dose level. If no intolerable side effects are experienced, the next group of participants will take a higher dose level. This process will continue until researchers find the highest dose of PBI-05204 that can be given without intolerable side effects occurring.
Study Drug Administration:
Depending on which group you are enrolled in, you will take the PBI-05204 capsules by mouth every day at the same time or twice a day (every 12 hours). Your Doctor will tell you which schedule you are on. You will take the drug on Days 1-21. On Days 22-28 you will take no study drug. Each 28 days is called a "study cycle".
Study Visits:
At the Predose Visit, 1-7 days before Day 1 of Cycle 1 you will have the following tests and procedures performed:
* You will have a physical exam, including measurement of your vital signs, height, and weight.
* You will have a performance status evaluation.
* Urine will be collected for routine tests.
* You will have an ECG, if applicable
* You will have your heart rate monitored by a Holter monitor. A Holter monitor is a machine that continuously records the heart's rhythms. Electrodes (small conducting patches) are stuck onto your chest and attached to a small recording monitor. You carry the Holter monitor in a pocket or in a small pouch worn around your neck or waist. The monitor is battery operated. After 24 hours, you return the monitor to the study doctor. The study doctor will look at the records and see if there have been any irregular heart rhythms.
* Blood (about 3-4 teaspoons) will be collected for routine tests.
* Women who are able to have children will have a blood (about 2 teaspoons) or urine pregnancy test.
On Day 1 Cycle 1 you will have the following tests and procedures performed:
* You will have a physical exam, including measurement of your vital signs.
* You will have a performance status evaluation.
* You will have an ECG. The ECG will be repeated on Day 1 of every later Cycle.
* Blood (about 3-4 teaspoons) and urine will be collected for routine tests.
* You will take your dose of PBI-05204 by mouth.
* Blood (about 2 teaspoons each time) will be collected for PK testing before you take the first daily dose of the study drug and then 1, 2, 4, 6, and 8 hours later.
* Blood (about 6 teaspoons) will be collected for pharmacodynamic (PD) testing before you take the study drug. PD testing is used to look at how the level of study drug in your body may affect the disease.
On Day 2 of Cycle 1 you will have the following:
* You will take your dose of PBI-05204 by mouth
* You will have an ECG.
On Day 7 of Cycle 1 you will have the following:
* Blood (about 6 teaspoons) will be drawn for PD testing.
* You will take your dose of PBI-05204 by mouth.
* You will have your heart rate monitored by a Holter monitor.
On Day 8 of Cycle 1 you will have the following tests and procedures performed:
* You will have a physical exam, including measurement of your vital signs.
* You will have a performance status evaluation.
* Blood (about 3-4 teaspoons) and urine will be collected for routine tests.
* You will take your dose of PBI-05204 by mouth.
* Blood (about 2 teaspoons each time) will be collected for PK testing before you take the first daily dose of the study drug and then 1, 2, 4, 6, and 8 hours later. Additional blood (about 2 teaspoons each time) will also be collected for PK testing before you take the second daily dose of the study drug and then 1, 2, 4, and 12 hours later.
* You will have an ECG.
On Day 15 of Cycle 1 you will have the following tests and procedures performed:
* You will have a physical exam, including measurement of your vital signs.
* You will have a performance status evaluation.
* You will have an ECG.
* Blood (about 3-4 teaspoons) and urine will be collected for routine tests.
* You will take your dose of PBI-05204 by mouth.
* Blood (about 2 teaspoons each time) will be collected for PK testing before you take the first daily dose of the study drug and then 1, 2, 4, 6, and 8 hours later.
On Day 21 of Cycle 1 you will have the following tests and procedures performed:
* You will have a physical exam, including measurement of your vital signs.
* You will have a performance status evaluation.
* Blood (about 3-4 teaspoons) and urine will be collected for routine tests.
* You will take your dose of PBI-05204 by mouth.
* Blood (about 2 teaspoons each time) will be collected for PK testing before you take the first daily dose of the study drug and then 1, 2, 4, 6, and 8 hours later. Additional blood (about 2 teaspoons each time) will also be collected for PK testing before you take the second daily dose of the study drug and then 1, 2, 4, and 12 hours later.
* Blood (about 6 teaspoons) will be collected for PD testing.
During the last week of Cycle 2, the following tests and procedures will be performed:
* You will have a physical exam, including measurement of your vital signs, height and weight.
* You will have a performance status evaluation.
* Blood (about 3-4 teaspoons) and urine will be collected for routine tests.
* You will have a CT or MRI scan to check the status of the disease.
* Women who are able to have children will have a blood (about 2 teaspoons) or urine pregnancy test.
On Day 1 of Cycles 3 and beyond you will have a physical exam, including measurement of your vital signs.
At the end of every 2 cycles beginning with Cycle 4 (Cycles 4, 6, 8, and so on) blood (about 3-4 teaspoons) and urine will be collected for routine tests. You will have a CT or MRI.
If you are enrolled in the expansion group, blood (about 2 teaspoons each time) will be collected for PK testing before you take the daily dose of the study drug and then 1, 2, 4, 6, 8 and 24 hours later on Day 1 of Cycle 1. On Days 8, 15 and 21 of Cycle 1, blood (about 2 teaspoons each time) will also be collected for PK testing before you take the daily dose of the study drug and then 1, 2, 4, 6 and 8 hours later.
If you are enrolled in the expansion group, you will also have two mandatory tumor biopsies collected within 1- 7 days before you take your daily dose of the study drug and once during Days 15-21 of Cycle 1. To collect the biopsy, your doctor will insert a needle into the tumor and withdraw a small piece of the tumor. The tumor tissue will be studied to look at special "markers" in the tumor that may help researchers predict who may benefit from the study drug.
Length of Study:
You will remain on study until the disease gets worse, you decide to come off study, your doctor decides it is in your best interest to come off the study, you have intolerable side effects, or the sponsor closes the study.
If you decided to leave the study early you must tell the study doctor in writing and return any unused study drug. You must complete the end-of-study visit.
End-of-Study Visit:
Once you are off-study, you will have an end-of-study visit within 30 days after the last dose of PBI-05204. At this visit, the following tests and procedures will be performed:
* You will have a physical exam, including a measurement of your vital signs.
* You will have a performance status evaluation.
* You will have an ECG.
* You will have your heart rate monitored by a Holter monitor.
* Blood (about 3-4 teaspoons) and urine will be collected for routine tests
* You will have a CT/MRI scan to assess your tumors.
* Women who are able to have children must have a blood (about 2 teaspoons) or urine pregnancy test.
Long-Term Follow-up:
After you complete the end-of-study visit, your study doctor will continue to contact you or your family doctor for a minimum of 30 days. You may be contacted by a phone call (less than 5 minutes), and you will be asked about your general health.
This is an investigational study. PBI-05204 is not FDA approved or commercially available. At this time, PBI-05204 is only being used in research. Up to 52 patients will take part in this study. All will be enrolled at M. D. Anderson.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: