Ignite Creation Date:
2024-05-05 @ 9:38 PM
Last Modification Date:
2024-10-26 @ 10:07 AM
Study NCT ID:
NCT00936117
Status:
COMPLETED
Last Update Posted:
2019-02-27
First Post:
2009-07-07
Brief Title:
Pharmacokinetics of Posaconazole Prophylaxis in Acute Leukemia
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Phase II Study of the Pharmacokinetics of Posaconazole Prophylaxis in Relapsed or Refractory Patients With Acute Leukemia
Status:
COMPLETED
Status Verified Date:
2019-02
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 learn the amount of posaconazole that is in the body at different time points when given to patients with leukemia The safety of this drug will also be studied
Objectives
Primary
To study the plasma pharmacokinetics of posaconazole in patients with newly diagnosed acute myelogenous leukemia AML or high-risk myelodysplastic syndrome HR-MDS undergoing induction chemotherapy or relapsed or refractory patients who will receive salvage chemotherapy
Secondary
To evaluate the safety of posaconazole given as prophylaxis
Objectives
Primary
To study the plasma pharmacokinetics of posaconazole in patients with newly diagnosed acute myelogenous leukemia AML or high-risk myelodysplastic syndrome HR-MDS undergoing induction chemotherapy or relapsed or refractory patients who will receive salvage chemotherapy
Secondary
To evaluate the safety of posaconazole given as prophylaxis
Detailed Description:
Chemotherapy can lower immune system function which can cause fungal infections to occur more easily The standard treatment for prevention of such infections includes drugs such as voriconazole and liposomal amphotericin B that help prevent fungus from growing
The Study Drug
Posaconazole is designed to block the ergosterol synthesis a part of the fungal membrane This may help to prevent fungal infections
Study Drug Administration
If you are found to be eligible to take part in this study you will take posaconazole by mouth 3 times per day Posaconazole is a liquid You should take the study drug after a full meal or with a liquid nutritional supplement such as a protein shake If you are not able to eat food you should take it with a carbonated beverage such as soda
Food and Drug Diary
You will be also be given a food and drug diary where you will write down the time you took each dose You should also record the time eaten and describe what you ate or drank at each meal This information will be used to find out the number of calories and amount of protein carbohydrates and fat you have consumed You will be given a small bag where you can keep the drug and diary You should return this diary after the last blood draw
Blood Draws for Pharmacokinetics PK Testing
While you are on study blood about 1 teaspoon each time will be drawn for PK testing PK testing measures the amount of study drug in the body at different time points
Days 1 3 and 10 before your first dose of study drug and 3 5 and 10 hours after the first dose of the day
Days 2 and 4 about 24 hours after the first dose the day before
Blood about 1 teaspoon will also be drawn for PK testing 1 time at any of the following time points
Before you start a new dose of study drug if the dose needs to be raised
If you stop taking the study drug due to intolerable side effects or a fungal infection
Note that if you are not already in the hospital on the days of the PK blood draws you will need to stay at the hospital for about 10 hours on these days
Length of the Study
You will take the study drug for up to 42 days You will be taken off study if you experience intolerable side effects if you develop an invasive fungal infection or if the doctor thinks it is in your best interest
This is an investigational study Posaconazole is FDA approved and commercially available for the prevention of fungal infections
Up to 25 patients will take part in the study All will be enrolled at MD Anderson
The Study Drug
Posaconazole is designed to block the ergosterol synthesis a part of the fungal membrane This may help to prevent fungal infections
Study Drug Administration
If you are found to be eligible to take part in this study you will take posaconazole by mouth 3 times per day Posaconazole is a liquid You should take the study drug after a full meal or with a liquid nutritional supplement such as a protein shake If you are not able to eat food you should take it with a carbonated beverage such as soda
Food and Drug Diary
You will be also be given a food and drug diary where you will write down the time you took each dose You should also record the time eaten and describe what you ate or drank at each meal This information will be used to find out the number of calories and amount of protein carbohydrates and fat you have consumed You will be given a small bag where you can keep the drug and diary You should return this diary after the last blood draw
Blood Draws for Pharmacokinetics PK Testing
While you are on study blood about 1 teaspoon each time will be drawn for PK testing PK testing measures the amount of study drug in the body at different time points
Days 1 3 and 10 before your first dose of study drug and 3 5 and 10 hours after the first dose of the day
Days 2 and 4 about 24 hours after the first dose the day before
Blood about 1 teaspoon will also be drawn for PK testing 1 time at any of the following time points
Before you start a new dose of study drug if the dose needs to be raised
If you stop taking the study drug due to intolerable side effects or a fungal infection
Note that if you are not already in the hospital on the days of the PK blood draws you will need to stay at the hospital for about 10 hours on these days
Length of the Study
You will take the study drug for up to 42 days You will be taken off study if you experience intolerable side effects if you develop an invasive fungal infection or if the doctor thinks it is in your best interest
This is an investigational study Posaconazole is FDA approved and commercially available for the prevention of fungal infections
Up to 25 patients will take part in the study All will be enrolled at MD Anderson
Study Oversight
Has Oversight DMC:
None
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?:
None