Oral Posaconazole in High Risk Patients With Gastrointestinal Dysfunction (Study P05115AM1)
Information source: Schering-Plough
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Fungal Infection; Acute Myelogenous Leukemia; Neutropenia
Intervention: Posaconazole (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Schering-Plough Overall contact:
SP Clinical Trial Registry Call Center, Phone: 1-888-772-8734
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.
Clinical Details
Official title: 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
Study design: Prevention, Randomized, Open Label, Dose Comparison, Parallel Assignment, Pharmacokinetics Study
Primary outcome: POS concentrations obtained from plasma. The primary POS oral PK parameter to be determined is the mean plasma concentration for each patient.
Secondary outcome: Adverse events (AEs), including breakthrough IFI and premature discontinuation due to adverse events, clinical laboratory tests, and vital signs are to be assessed. Serious adverse events (SAEs) will be reported.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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 IFI based on anticipated or documented prolonged neutropenia (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.
Locations and Contacts
SP Clinical Trial Registry Call Center, Phone: 1-888-772-8734
Investigational Site 1, Leuven 3000, Belgium; Recruiting
Investigational Site 2, Koeln 50937, Germany; Recruiting
Investigational Site 3, Homburg/Saar 66424, Germany; Recruiting
Investigational Site 4, Wuerzburg 97080, Germany; Recruiting
Investigational Site 7, Atlanta, Georgia 30322, United States; Recruiting
Investigational Site 5, Detroit, Michigan 48201, United States; Recruiting
Investigational Site 10, Minneapolis, Minnesota 55455, United States; Recruiting
Investigational Site 6, New York, New York 10021, United States; Recruiting
Investigational Site 8, Durham, North Carolina 27710, United States; Recruiting
Additional Information
Starting date: December 2007
Ending date: April 2009
Last updated: January 19, 2009
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