Pharmacokinetics of Posaconazole Prophylaxis in Acute Leukemia

This study has been completed.
Sponsor:
Collaborator:
Schering-Plough
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00936117
First received: July 7, 2009
Last updated: September 6, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Leukemia
Fungal Infection
Drug: Posaconazole
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
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. ] [ Designated as safety issue: No ]

Enrollment: 25
Study Start Date: September 2009
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT00936117

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

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00936117     History of Changes
Other Study ID Numbers: 2008-0793
Study First Received: July 7, 2009
Last Updated: September 6, 2013
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Infection
Leukemia
Mycoses
Neoplasms
Neoplasms by Histologic Type
Posaconazole
14-alpha Demethylase Inhibitors
Anti-Infective Agents
Antifungal Agents
Antiparasitic Agents
Antiprotozoal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Trypanocidal Agents

ClinicalTrials.gov processed this record on October 23, 2014