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A Randomized Controlled Trial of Posaconazole (SCH 56592) Vs. Standard Azole Therapy for the Prevention of Invasive Fungal Infections Among High-Risk Neutropenic Patients


Phase 3
13 Years
N/A
Not Enrolling
Both
Leukemia, Myelocytic, Acute, Myelodysplastic Syndromes, Neutropenia

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Trial Information

A Randomized Controlled Trial of Posaconazole (SCH 56592) Vs. Standard Azole Therapy for the Prevention of Invasive Fungal Infections Among High-Risk Neutropenic Patients


This study is designed to determine the safety, tolerance and efficacy of POZ used as
prophylaxis if IFI in high-risk subjects with prolonged profound neutropenia. The primary
objective is to assess the efficacy of SCH 56592 vs fluconazole and itraconazole in
preventing proven or probable IFI during neutropenic episodes.


Inclusion Criteria:



- Adults or adolescents (age>13 years) and weight> 34kg, either gender

- Disease definition: Anticipated or documented prolonged neutropenia (ANC<500/mm3 2)
Eastern Cooperative Oncology Group (ECOG) performance score of less than 3.

- Female subjects of childbearing age must be using a medically accepted method of
birth control before beginning study-drug treatment and agree to continue its use
during the study or be surgically sterilized (eg, hysterectomy or tubal ligation).

- Female subjects of childbearing potential must have a negative serum pregnancy test
(beta-hcG) at Baseline or within 72 hours before the start of the study drug.

Exclusion Criteria:

- Female subjects who are pregnant, intend to become pregnant, or are nursing.

- Excluded prior treatments: Subjects previously treated with AMB, FLZ, or ITZ for
proven or probable IFI within 30 days of enrollment.

- Excluded treatments prior to specific study phases: Subjects who have taken the
following drugs: those known to interact with azoles and that may lead to
life-threatening side effects.

- Subjects who have used any investigational drugs or biologic agents other than their
chemotherapy regimens within 30 days of study entry.

- Subjects who are participating in any other blinded clinical study within 30 days of
study entry.

- Subjects with renal insufficiency (estimated creatinine clearance less than 20
mL/minute at Baseline or likely to require dialysis during the study).

- Subjects having an ECG with a prolonged QTc interval by manual reading: QTc greater
than 450 msec for men and greater than 470 msec for women.

- Subjects with moderate or severe liver dysfunction at baseline, defined as aspartate
aminotransferase (AST), alanine aminotransferase (ALT), or alkaline phosphatase
levels greater than 5 times the upper limit of normal (ULN), or a total bilirubin
level greater than 3 times the ULN.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Authority:

United States: Food and Drug Administration

Study ID:

P01899

NCT ID:

NCT00044486

Start Date:

July 2002

Completion Date:

May 2005

Related Keywords:

  • Leukemia, Myelocytic, Acute
  • Myelodysplastic Syndromes
  • Neutropenia
  • Prophylaxis
  • neutropenia
  • AML
  • MDS
  • fungal infections
  • Acute Myelogenous Leukemia
  • Anticipated prolonged profound neutropenia
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Mycoses
  • Myelodysplastic Syndromes
  • Preleukemia
  • Neutropenia

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