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A Phase 4 Study of the Pharmacokinetics of Oral Posaconazole (SCH 56592) Among Patients With Compromised Gastrointestinal Function and at High Risk for Invasive Fungal Infection

Phase 4
18 Years
Not Enrolling
Fungal Infection, Acute Myelogenous Leukemia, Neutropenia

Thank you

Trial Information

A Phase 4 Study of the Pharmacokinetics of Oral Posaconazole (SCH 56592) Among Patients With Compromised Gastrointestinal Function and at High Risk for Invasive Fungal Infection

Inclusion Criteria:

- Subjects >=18 years of age

- High risk of poor enteral medication absorption, based on the effects of cytotoxic
chemotherapy, as evidenced by, but not limited to, mucositis, nausea, vomiting, and
diarrhea, at baseline.

- High risk of invasive fungal infection (IFI) based on anticipated or documented
prolonged neutropenia (absolute neutrophil count [ANC] <500/mm^3 [0.5 x 10^9/L]).

- Clinical laboratory safety tests within normal limits or clinically acceptable to the
investigator or sponsor.

- Free of any clinically significant disease (other than the primary hematologic
disease) that would interfere with the study evaluations.

- Subjects must be willing to give written informed consent and able to adhere to
dosing, study visit schedule, and mandatory procedures.

Exclusion Criteria:

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

- Excluded prior treatments. Subjects receiving systemic antifungal therapy (oral,
intravenous, or inhaled) for the treatment of proven or probable IFI within 30 days
of Enrollment (ie, voriconazole, fluconazole [FLU], or itraconazole [ITZ]).

- Subjects receiving posaconazole for prophylaxis against IFI 10 days prior to
enrollment. (Subjects who are receiving either voriconazole or micafungin for
prophylaxis against IFI should discontinue those therapies upon enrollment.)

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

- Subjects who have taken prohibited medications more recently than the indicated
washout period prior to Enrollment.

- Subjects who must take prohibited medications during the study.

- Subjects who are in a situation or have any condition that, in the opinion of the
investigator, may interfere with optimal participation in the study.

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

- Subjects who are part of the staff personnel directly involved with this study.

- Subjects who are a family member of the investigational study staff.

- Prior enrollment in this study.

- Subjects with a history of hypersensitivity or idiosyncratic reactions to azole

- Subjects with Eastern Cooperative Oncology Group (ECOG) performance status >2 prior
to induction chemotherapy for their underlying disease.

- Subjects with proven or probable invasive or systemic fungal infection at Baseline.

- Subjects with a history of acute lymphoblastic leukemia or chronic myelogenous
leukemia without blast crisis.

Type of Study:


Study Design:

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

Outcome Measure:

Mean POS Plasma Concentrations on Days 2, 3, and 8.

Outcome Description:

Individual mean concentrations were calculated as the average of observed concentrations at 0 hour (before the morning dose) and 5 hours after the morning dose.

Outcome Time Frame:

Predose (0 hour) and 5 hours postdose on Days 2, 3, and 8

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

December 2007

Completion Date:

April 2009

Related Keywords:

  • Fungal Infection
  • Acute Myelogenous Leukemia
  • Neutropenia
  • Antifungal Agents
  • Anti-Infective Agents
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Mycoses
  • Neutropenia