Oral Posaconazole in High Risk Patients With Gastrointestinal Dysfunction (Study P05115)
Condition: Fungal Infection; Acute Myelogenous Leukemia; Neutropenia
MeSH terms: Infections; Mycoses; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Neutropenia
Intervention: Posaconazole
Intervention description: Posaconazole will be used for prophylaxis
Intervention MeSH terms: Posaconazole
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 75.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Antifungal Agents; Anti-Infective Agents

Summary:

      The purpose of this study is: to explore the potential for different dosing strategies of
      posaconazole oral suspension (POS) to increase plasma levels and to profile the
      pharmacokinetics of these dosing strategies in patients with compromised gastrointestinal
      function and at high risk for Invasive Fungal Infection.
    

Eligibility criteria:

        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
             agents.

          -  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.