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Pharmacokinetics of Posaconazole Prophylaxis in Acute Leukemia

This study has been completed.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center Identifier:
First received: July 7, 2009
Last updated: August 24, 2015
Last verified: May 2015

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.



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.


To evaluate the safety of posaconazole given as prophylaxis.

Condition Intervention Phase
Fungal Infection
Drug: Posaconazole
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of the Pharmacokinetics of Posaconazole Prophylaxis in Relapsed or Refractory Patients With Acute Leukemia

Resource links provided by NLM:

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Maximum Observed Concentration in Plasma (Cmax) [ Time Frame: Pharmacokinetics: Day 1, Day 3 and Day 10 of prophylaxis. ]

    Pharmacokinetic samples were obtained on day 1, day 3 and day 10 of prophylaxis. A total of 15 samples (3 ml each sample) per participant were obtained, with thrice daily dosing planned around standard meal times. On day 1 and day 3 of prophylaxis sampling was done pre dose (0), and at 3, 5, 10 and 24 hours (±10 minutes) post dose from the time of the first dose of the day. On day 10 of prophylaxis sampling was done pre dose (0), and at 3, 5, and 10 hours (±10 minutes) post dose from the time of the first dose of the day.

    Posaconazole levels were assayed by high performance liquid chromatography (HPLC). The testing range for posaconazole is from 125 - 5000 ng/ml. There are no established therapeutic ranges for posaconazole.

Enrollment: 25
Study Start Date: September 2009
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Posaconazole
Posaconazole 200 mg (liquid) by mouth 3 times per day.
Drug: Posaconazole
200 mg (liquid) by mouth 3 times per day.
Other Names:
  • SCH 56592
  • Noxafil

  Show Detailed Description


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 chemotherapy)
  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 fluconazole

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 posaconazole
  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 seconds).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00936117

United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Study Chair: Jorge Cortes, MD UT MD Anderson Cancer Center
  More Information

Additional Information:
Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00936117     History of Changes
Other Study ID Numbers: 2008-0793
Study First Received: July 7, 2009
Results First Received: May 28, 2015
Last Updated: August 24, 2015

Keywords provided by M.D. Anderson Cancer Center:
Cancer of the Blood
Cancer of Bone Marrow
Acute Leukemia
Fungal infection
SCH 56592

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Antifungal Agents
Anti-Infective Agents
Trypanocidal Agents
Antiprotozoal Agents
Antiparasitic Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs processed this record on May 23, 2017