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Phase II Study of the Pharmacokinetics of Posaconazole Prophylaxis in Relapsed or Refractory Patients With Acute Leukemia

Phase 2
18 Years
Open (Enrolling)
Leukemia, Fungal Infection

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Trial Information

Phase II Study of the Pharmacokinetics of Posaconazole Prophylaxis in Relapsed or Refractory Patients With Acute Leukemia

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.

Inclusion Criteria:

1. Patients newly diagnosed with AML or high-risk MDS undergoing induction chemotherapy
or refractory or relapsed patients with AML or high-risk MDS who will receive first
or second salvage chemotherapy. (Salvage patients are defined as patients that
achieved remission and relapsed or patients who were refractory to initial frontline

2. Age > 18 years and able to take oral intake.

3. Patients must sign an informed consent.

4. Patients agree to medically approved forms of contraception

5. Patients on prior antifungal prophylaxis with voriconazole, itraconazole or
fluconazole are eligible if they completed 3 days wash-out period if on voriconazole,
or 14 days wash-out period if on itraconazole or 7 days wash-out period if on

Exclusion Criteria:

1. Patients with history of anaphylaxis attributed to azole compounds

2. Patients with clinical or other evidence that indicates that they have proven or
probable invasive fungal infection prior to enrollment (EORTC criteria)

3. Patients with baseline total bilirubin levels > 3 times the upper normal limits (i.e.
> 3.0 mg/dl); or baseline SGPT > 5 times upper limit normal.

4. Patients receiving any medication that is contraindicated with the use of

5. Patients with baseline creatinine levels NCI grade 3 or above (> 3.0 - 6.0 X ULN)

6. Patients with baseline QTc prolongation NCI grade 1 or above (QTc > 0.45 - 0.47

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum Observed Concentration in Plasma (Cmax)

Outcome Time Frame:

Pharmacokinetics: Day 1, Day 3 and Day 10 of prophylaxis.

Safety Issue:


Principal Investigator

Jorge Cortes, MD

Investigator Role:

Study Chair

Investigator Affiliation:

UT MD Anderson Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

September 2009

Completion Date:

Related Keywords:

  • Leukemia
  • Fungal Infection
  • Cancer of the Blood
  • Cancer of Bone Marrow
  • Acute Leukemia
  • AML
  • Fungal infection
  • Prophylaxis
  • Posaconazole
  • SCH 56592
  • Noxafil
  • Chemotherapy
  • Leukemia
  • Mycoses
  • Acute Disease



UT MD Anderson Cancer Center Houston, Texas  77030